Cap. 138 sub. leg. A

Pharmacy and Poisons Regulations(Cap. 138, section 29) [1 July 1978] L.N. 145 of 1978(Format changes—E.R. 3 of 2015) Part 1 Preliminary 1. Citation These regulations may be cited as the Pharmacy and Poisons Regulations. 2. Interpretation (1) In these regulations, unless the context otherwise requires—antimonial poisons (含銻毒藥) means organic and inorganic compounds of antimony;arsenical poisons (含砷毒藥) means organic and inorganic compounds of arsenic;authorized person (獲授權人) means a person whose name is entered in the register of authorized persons; (2 of 2015 s. 32)British Pharmaceutical Codex (英國藥學藥典), British Pharmacopoeia (英國藥典), British National Formulary (英國國家處方集) and British Veterinary Codex (英國獸醫藥方集) include the supplements thereto;expiry date (使用期限)—see paragraph (1A); (19 of 2020 s. 5)food (食物) includes a beverage;GMP Guide (《指引》) means the Good Manufacturing Practice Guide issued under regulation 28A as revised from time to time under that regulation; (2 of 2015 s. 32)medicine for the internal treatment of human and animal ailments (用於治療人類及動物病患的內服藥物) includes any medicine to be administered by injection, but does not include any mouth-wash, eye-drops, eye-lotion, ear-drops, nasal drops, douche or similar article;register of authorized persons (獲授權人名冊) means the register of authorized persons kept under regulation 30B; (2 of 2015 s. 32)specified form (指明格式), in relation to a purpose under these regulations, means the form specified for that purpose under regulation 38B; (2 of 2015 s. 32)Tribunal (審裁處) means the Pharmacy and Poisons Appeal Tribunal established by section 30 of the Ordinance; (L.N. 369 of 1980)veterinary institution (獸醫機構) means a veterinary hospital, veterinary clinic or other premises where sick animals are treated.(1A) For the purposes of these regulations, the expiry date of a pharmaceutical product is the date determined by the manufacturer of the product—(a) on the basis of the product’s specifications; and(b) on the assumption that the product is stored under conditions suitable to it,as the date after which the product should not be used. (19 of 2020 s. 5)(2) In these regulations any reference to an alkaloid shall include a reference to any salt of that alkaloid, and, in a case where the esters of an alkaloid are included in the Poisons List by virtue of the words “its esters”, to any esters of that alkaloid.(3) Any reference in the Schedules to these regulations to the percentage of a poison contained in any substance or preparation shall, unless otherwise expressly provided, be construed in the following manner, that is to say, a reference to a substance or preparation containing 1 per cent of any poison means—(a) in the case of a solid, that 1 gram of the poison is contained in every 100 grams of the substance or preparation; (E.R. 5 of 2020)(b) in the case of a liquid, that 1 millilitre of the poison, or, if the poison itself is a solid, 1 gram of the poison, is contained in every 100 millilitres of the substance or preparation, (E.R. 5 of 2020)and so in proportion for any greater or less percentage.(4) Substances listed in Divisions A in the Schedules to these regulations are those whose uses are essentially medicinal, whilst substances listed in Divisions B are not normally used medicinally. (L.N. 41 of 2007)(5) Where in these regulations reference is made to a numbered section the reference shall be a reference to that section of the Ordinance. (6) Where functions are conferred on a committee by any provision of these regulations, references in such provision to “the Committee” shall be construed as references to the executive committee established under section 4A of the Ordinance for the purpose of performing such functions. (L.N. 369 of 1980) 2A. Poisons List The Poisons List is set out in Schedule 10.(2 of 2015 s. 33) 3. Application of section 22 restricted to Schedule 1 (E.R. 5 of 2020)Section 22 shall only apply to those poisons included in Part 1 of the Poisons List which are also included in Schedule 1 but not included in Schedule 3.(L.N. 202 of 1999; 2 of 2015 s. 34; E.R. 3 of 2015; E.R. 5 of 2020) 4. Extension of labelling provisions and relaxation with respect to poisons in Schedule 6 (E.R. 5 of 2020)(1) Subject to paragraph (2), the provisions of section 27 and regulations 12 to 17 (which provisions relate to the labelling of poisons) shall apply to sales exempted by section 32, and shall also apply to the supply of poisons (otherwise than on sale) and references in those provisions to the sale and the seller of poisons shall be deemed to refer to the supply and the supplier of poisons respectively. (2) In the case of the sale or supply of any of the poisons included in Schedule 6 to a person who— (E.R. 5 of 2020)(a) carries on a business in the course of which poisons are regularly sold by way of wholesale dealing or are regularly used in the manufacture of other articles; and(b) requires the poison for the purpose of that business,if the outside of the package in which the poison is sold or supplied is labelled conspicuously with words indicating the dangerous properties of the poison, it shall be necessary to comply only with regulation 15 and section 27(a) and section 27(d) (as modified by regulation 17).(E.R. 3 of 2015) 5. Extension of section 22 to sales wholesale etc. and relaxation of the section (1) Section 22 shall apply to sales exempted by section 32, except sales of poisons to be exported to purchasers outside Hong Kong, and shall also apply to the supply in the form of a commercial sample, otherwise than on sale, of any substance included in Schedule 1 in like manner as if references in section 22 to the sale and seller of poisons respectively included references to the supply and the supplier of poisons in the form of commercial samples: (E.R. 5 of 2020) Provided that section 22 shall not apply to the sale or supply of any article by the licensed manufacturer thereof or by a person carrying on a business in the course of which poisons are regularly sold by way of wholesale dealing, if— (2 of 2015 s. 35) (a) the article is sold or supplied to a person carrying on a business in the course of which poisons are regularly sold or are regularly used in the manufacture of other articles; and (b) the seller or supplier is reasonably satisfied that the purchaser requires the article for the purpose of that business. (2) Section 22(1) shall, in its application to sales exempted by section 32 and to the supply in the form of commercial samples of substances included in Schedule 1, be deemed to be satisfied if the person to whom the poison or sample is sold or supplied is known by the person in charge of the department of the business through which the sale or supply is effected to be a person to whom the poison or sample may properly be sold or supplied. (E.R. 5 of 2020)(3) Subject to paragraph (4), so much of section 22(3)(b) as requires an entry in the poisons book to be signed by the purchaser of a poison shall not, as respects the sale of a poison to a person for the purpose of his trade, business or profession, apply if the following requirements are satisfied—(a) the seller shall obtain before the completion of the sale an order in writing signed by the purchaser stating his name and address, trade, business or profession, the name and quantity of the article to be purchased, and the purpose for which it is required;(b) the seller shall be reasonably satisfied that the signature is that of the person purporting to have signed the order, and that that person carries on the trade, business or profession stated in the order, being one in which the poison to be purchased is used; and(c) if the article sold is sent by post, it shall be sent by registered post.(4) Where a person represents that he urgently requires a poison for the purpose of his trade, business or profession, the seller may, if he is reasonably satisfied that the person so requires the poison and is, by reason of some emergency, unable before delivery either to furnish to the seller an order in writing duly signed or to attend and sign the entry in the book, deliver the poison to the purchaser on an undertaking by the purchaser to furnish such an order within 48 hours next following.(5) Any purchaser by whom an undertaking under paragraph (4) has been given who fails to deliver to the seller a signed order in accordance with the undertaking, or any person who for the purpose of obtaining delivery of any poison makes a statement which is to his knowledge false in any material particular shall be guilty of an offence and shall be liable on conviction to a fine at level 3 and to imprisonment for 12 months. (2 of 2015 s. 35)(6) In the case of a sale or the supplying of a poison included in Schedule 1 to an institution such of the provisions of this regulation as require the purchaser to state his trade, business or profession and the seller to be satisfied with respect thereto shall not apply and for the reference in paragraph (4) to the purposes of the purchaser’s trade, business or profession there shall be substituted in the case of any such sale a reference to the name of the institution and the full name and rank or position held at the institution of the person making the order. (E.R. 5 of 2020)(E.R. 3 of 2015) 6. Relaxation of section 28(3) in the case of certain medicines The requirements of section 28(3) (which requires particulars of medicines supplied or dispensed under that section to be entered in a book) shall be satisfied in respect of medicines included in Schedule 1, but need not be satisfied in respect of other medicines which are supplied by— (E.R. 5 of 2020)(a) a registered medical practitioner for the purposes of medical treatment; or(b) an authorized seller of poisons on and in accordance with a prescription given by a registered medical practitioner.(E.R. 3 of 2015) 7. Exemption from the provisions relating solely to Schedule 1 (E.R. 5 of 2020)The provisions of these regulations and of the Ordinance (as modified by these regulations) which apply solely to the substances in Schedule 1 shall not apply to— (E.R. 5 of 2020)(a) machine-spread plasters;(b) surgical dressings; or(c) (Repealed L.N. 262 of 1995)(d) corn paints in which the only poison is a poison included in the Poisons List under the item “Cannabis”.(E.R. 3 of 2015; E.R. 5 of 2020) 8. Complete exemption for articles and substances in Schedule 2 (E.R. 5 of 2020)(1) Subject to paragraph (2), nothing in the Ordinance or these regulations shall apply—(a) to any article in Group I of Schedule 2; or(b) to any of the articles or substances specified in the second column of Group II of Schedule 2 opposite the description of the poison specified in the first column thereof. (L.N. 85 of 1987; E.R. 5 of 2020)(2) Notwithstanding paragraph (1)(b), Parts 6, 7, 8, 9 and 10 of these regulations shall apply to every article or substance referred to in that paragraph, that is a pharmaceutical product within the meaning of the Ordinance. (L.N. 85 of 1987; 2 of 2015 s. 36)(E.R. 3 of 2015) Part 2 Additional Restrictions on the Sale of Poisons 9. Additional restriction of sale of poisons in Schedule 3 (E.R. 5 of 2020)(1) No person shall sell any poison included in Schedule 3, except on and in accordance with a prescription given by a registered medical practitioner, registered dentist or registered veterinary surgeon. (L.N. 614 of 1997; E.R. 5 of 2020)(2) This regulation shall apply to the sale of any such poison, including a medicine exempted by section 28, but shall not apply to any sale exempted by section 32.(3) For the purposes of this regulation a prescription shall—(a) be in writing and be signed by the person giving it with his usual signature and be dated by him;(b) specify the address of the person giving it;(c) specify the name and address of the person for whose treatment it is given or, if the prescription is given by a registered veterinary surgeon, of the person to whom the medicine is to be delivered; (L.N. 614 of 1997)(d) have written thereon, if given by a dentist, the words “For dental treatment only 祇限牙科醫療用”, or, if given by a registered veterinary surgeon, the words “For animal treatment only 祇限醫治禽畜用”; and (L.N. 614 of 1997)(e) indicate the total amount of the medicine to be supplied and the dose to be taken or administered.(4) The person dispensing the prescription shall comply with the following requirements—(a) the prescription shall not be dispensed more than once unless the prescriber has directed either—(i) that it may be dispensed a stated number of times; or(ii) that it may be dispensed at stated intervals;(b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals, it shall not be dispensed otherwise than in accordance with the direction;(c) at the time of dispensing there shall be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed; and(d) except in the case of a prescription which may be dispensed again, the prescription shall, for a period of 2 years, be retained and kept on the premises on which it was dispensed in such manner as to be readily available for inspection.(E.R. 3 of 2015) 10. Restriction of sales by listed sellers of poisons No listed seller of poisons shall sell any poison other than a solution of ammonia, hydrochloric acid, nitric acid, potassium quadroxalate or sulphuric acid, except in a closed container as closed by the manufacturer or other person from whom the poison was obtained. 10A. Prohibition on dispensing of prescriptions by listed sellers of poisons No listed seller of poisons shall dispense any prescription for medicine.(L.N. 85 of 1987) 11. Restriction of sale of strychnine (1) No person shall sell or supply strychnine except as an ingredient in a medicine.(2) This regulation shall extend to transactions exempted by section 32, but shall not apply to the sale of strychnine—(a) by way of wholesale dealing;(b) to be exported to purchasers outside Hong Kong;(c) for the purpose of being compounded in medicines prescribed or administered by a registered medical practitioner or registered veterinary surgeon; or (L.N. 614 of 1997)(d) to a person or institution concerned with education, scientific research or chemical analysis, for the purpose of that education, research or analysis. Part 3 Supplementary Provisions with respect to Labelling and Containers of Poisons (2 of 2015 s. 73) 12. Manner of labelling containers (1) Subject to paragraphs (2) and (3), the particulars with which the container of a poison is required to be labelled under section 27 and under these regulations, shall appear in a conspicuous position on the container in which the poison is sold and on every box or other covering of whatever nature enclosing the container, and the particulars shall be clearly and distinctly set out and not in any way obscured or obliterated.(2) Where the poison is contained in a cachet or similar article it shall not be necessary to label the article itself, if every box or other covering in which the article is enclosed is labelled in accordance with paragraph (1).(3) Nothing in section 27 or in this regulation or regulations 13 to 17 shall be deemed to require the labelling of any transparent cover or any wrapper, hamper, packing case, crate or other covering used solely for the purposes of transport or delivery. 13. Labelling of name of poison (1) For the purposes of section 27(a) and regulation 22(3)(a), the name of a poison shall be the term under which it is included in the Poisons List: Provided that, where the term describes a group of poisons and not the poison specifically, the name of the poison shall be— (a) if the poison is the subject of a monograph in either the British Pharmacopoeia, the British Pharmaceutical Codex or the British Veterinary Codex, one of the names or synonyms or abbreviated names set out at the head of the monograph; or (b) in any other case, the accepted scientific name or the name descriptive of the true nature and origin of the poison. (2) For the purposes of the proviso to paragraph (1), where—(a) a substance is the subject of a monograph in the British Pharmacopoeia, the British Pharmaceutical Codex or the British Veterinary Codex, or any dilution, concentration or admixture of such substance; or(b) a preparation is contained in the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary or the British Veterinary Codex, or any dilution, concentration or admixture of such preparation; or(c) a surgical dressing of a type for which a standard is prescribed in the British Pharmaceutical Codex,it shall be sufficient to state the name, synonym or abbreviated name used to describe the substance, preparation or surgical dressing with the addition of the letters B.P., B.P.C., B.N.F. or B. Vet. C., as the case may be. 14. Labelling of particulars as to proportions of the poison For the purpose of section 27(b) (which requires preparation containing poisons to be labelled with particulars as to the proportion of each poison therein)—(a) in the case of a preparation containing a poison specified in the first column of Schedule 4, it shall be sufficient to state on the label the particulars specified in the second column of that Schedule against the description of the poison; (E.R. 5 of 2020)(b) in the case of a substance, preparation or surgical dressing which is named in accordance with regulation 13(2), it shall not be necessary to state on the label the proportion of the poison contained in the substance, preparation or surgical dressing, and in the case of any dilution, concentration or admixture of such substance or preparation it shall be sufficient to state the proportion which the substance or preparation bears to the total ingredients of that dilution, concentration or admixture;(c) where the poison is in tablets, pills, cachets, capsules, lozenges or similar articles, it shall be sufficient to state on the label of the box or other covering in which the articles are enclosed the number of the articles and the amount of the poison, or in the case of a preparation or substance mentioned in subparagraph (b), the amount of the preparation or substance, contained in each article; (E.R. 5 of 2020)(d) where the poison is in ampoules it shall be sufficient to show the name of the poison contained in it together with, either its concentration (if in solution or in emulsified form), or the quantity (if in solid form); and(e) where any proportion is stated as a percentage, the statement shall indicate whether the percentage is calculated on the basis of weight in weight, weight in volume, or volume in volume.(E.R. 3 of 2015) 15. Poisons to be labelled “Poison 毒藥” or other bilingual text specified in Schedule 5 etc. (E.R. 1 of 2016)(1) For the purposes of section 27(c), a container of a medicine must be labelled in clear print with the text in both English and Chinese as specified in Schedule 5 in respect of the medicine or the class to which the medicine belongs.(2) For the purposes of section 27(ca), a container of a substance or mixture of substances that is not a medicine must be labelled with the following text in clear print—(a) the text in both English and Chinese as specified in Schedule 5 in respect of the substance or mixture or the class to which the substance or mixture belongs; or(b) if no text is so specified, “Poison 毒藥”.(3) The text referred to in paragraph (1) or (2) must not be modified in meaning by the addition of any other texts or marks.(2 of 2015 s. 37; E.R. 1 of 2016) 16. Special precautions in the case of certain articles (1) No person shall sell or supply any poison—(a) in the case of a liquid other than a medicine, in a container of a capacity of not more than 2 litres, unless the container is labelled with the words “Not to be taken 忌食”; and (L.N. 22 of 1982)(b) in the case of an embrocation, liniment, lotion, liquid antiseptic, or other liquid medicine for external application, unless the container is labelled with the type of preparation and the words “For external use only 祇供外用”. (L.N. 137 of 1978)(2) No person shall sell or supply any compressed hydrocyanic acid, unless the container thereof is labelled with the words “Warning. This container holds poisonous gas and should only be opened and used by persons having expert knowledge of the precautions to be taken in its use. 警告：此容器內載毒氣，祇限由具有專門知識而在使用上知所提防之人士開啟及使用。”. (E.R. 5 of 2020)(3) This regulation shall be in addition to the other requirements of the Ordinance and of these regulations with respect to labelling and shall apply to the transactions referred to in sections 28 and 32, but shall not apply to the sale or supply of poisons to be exported to purchasers outside Hong Kong. 17. Name of seller and address of premises (1) Section 27(d) (which requires the container of a poison to be labelled with the name of the seller and the address of the premises on which it was sold) shall apply to the transactions referred to in section 32, but shall not apply—(a) in the case of an article sold for the purpose of being sold again in the same container; or(b) to poisons to be exported to purchasers outside Hong Kong.(2) The requirements of section 27(d) shall be deemed to be satisfied, in the case of a poison supplied from a warehouse or depot, if the container of the poison is labelled with the address of the supplier’s principal place of business.(3) Where any poison (other than a substance included in Schedule 1) is sold in a container and outer covering, being the container and covering in which it was obtained by the seller, it shall be sufficient if the name of the seller and the address of the premises on which it was sold appear only on the outer covering. (E.R. 5 of 2020)(4) Where the names of more than one person or more than one address appear on any label, there shall also be words on the label indicating clearly which person is the seller and at which of the addresses the poison was sold.(E.R. 3 of 2015) 18. Form of containers of poisons (2 of 2015 s. 73)(1) No person shall sell, whether wholesale or retail, or supply any poison unless—(a) it is contained in a container impervious to the poison and sufficiently stout to prevent leakage arising from the ordinary risks of handling and transport; and(b) in the case of a liquid contained in a glass bottle or plastic container containing not more than 2 litres, not being a medicine made up ready to be taken for the internal treatment of human or animal ailments, the outer surface of the bottle or container is fluted vertically with ribs or grooves recognizable by touch. (L.N. 22 of 1982)(2) Paragraph (1)(a) shall apply to the transactions referred to in section 28, and paragraph (1)(b) shall apply to the transactions exempted by section 32 but shall not apply to the sale or supply of poisons to be exported to purchasers outside Hong Kong. Part 4 Storage and Transport of Poisons (2 of 2015 s. 73) 19. Storage of poisons (1) No person shall store any poison except in a container impervious to the poison and sufficiently stout to prevent leakage from the container arising from the ordinary risks of handling.(2) No person shall store any poison included in Part 1 of the Poisons List in any retail shop or premises used in connexion therewith unless the substance is stored— (2 of 2015 s. 38)(a) in a receptacle reserved solely for the storage of poisons, which receptacle shall be locked with an adequate lock the key for which shall be retained by the registered pharmacist; and (L.N. 197 of 1989; L.N. 366 of 1995)(b) in a part of the premises to which customers are not permitted to have access and which is partitioned off or otherwise separated from the remainder of the premises.(3) No food shall be stored in the part of the premises where such poison is stored. (2 of 2015 s. 38)(E.R. 3 of 2015) 20. Transport of poisons No person shall consign any poison for transport unless it is sufficiently stoutly packed to avoid leakage arising from the ordinary risks of handling and transport. 21. Special provisions with respect to the transport of poisons in Schedule 7 (E.R. 5 of 2020)(1) No person shall consign for transport by carrier any poison included in Schedule 7 unless the outside of the package containing the article is labelled conspicuously with the name or description of the poison as set forth in that Schedule and a notice indicating that it is to be kept separate from food and from empty containers in which food has been contained.(2) No person shall knowingly transport any poison included in Schedule 7, either on his own behalf or for another person, in any vehicle in which food is being transported, unless the food is carried in a part of the vehicle effectively separated from that containing the poison, or is otherwise adequately protected from the risk of contamination.(3) This regulation shall not apply to medicines.(E.R. 3 of 2015; E.R. 5 of 2020) Part 5 Special Provisions with respect to Institutions 22. Supply of medicines to out-patients from certain institutions, etc. (1) Nothing in the Ordinance or in these regulations, except regulation 16, this Part and Part 7, applies with respect to— (L.N. 262 of 1995; 19 of 2020 s. 6)(a) any medicine dispensed in an institution where the dispensing is under the supervision of a registered pharmacist or other person as may be approved by the Director of Health; or (L.N. 76 of 1989)(b) any medicine for the treatment of animals supplied from a veterinary institution which is under the superintendence of a registered veterinary surgeon, (L.N. 614 of 1997)if the requirements of this regulation are satisfied in relation thereto.(2) The medicine shall not be supplied except by, or on and in accordance with a prescription of, a duly registered medical practitioner for the purposes of medical treatment, or a registered dentist for the purposes of dental treatment, or a registered veterinary surgeon for the purposes of animal treatment. (L.N. 614 of 1997)(3) In a case where a substance included in Schedule 1 is supplied, a record shall be kept on the premises in such a way that there can readily be traced at any time during a period of 2 years after the date on which the substance was supplied the following particulars— (E.R. 5 of 2020)(a) the name and quantity of the poison supplied;(b) the date on which the poison was supplied;(c) the name and address of the person to whom the poison was supplied; and(d) the name of the person who supplied the poison or who gave the prescription upon which it was supplied.(4) The container of the medicine shall be labelled—(a) with a designation sufficient to identify the institution or veterinary institution from which it was supplied; and (L.N. 137 of 1978; 2 of 2015 s. 39)(b) (Repealed 2 of 2015 s. 39)(c) in the case of a poison supplied from a veterinary institution, with the words “For animal treatment only 祇限醫治禽畜用”.(5) The medicine shall be clearly labelled with instructions for use in either English or Chinese. (2 of 2015 s. 39)(6) In the case of a medicine to which regulation 16 applies the requirements of that regulation shall be satisfied in addition to the requirements of this regulation.(E.R. 3 of 2015) 23. Supply of medicines for use in institutions, etc. (1) In any institution in which medicines are dispensed in a dispensing or pharmaceutical department in charge of a registered pharmacist or any other person approved by the Director of Health for that purpose, no medicine containing a poison shall be supplied from that department, except in cases of emergency, for use in the wards, operating theatres or other sections of the institution, except in accordance with paragraphs (2) and (3). (L.N. 76 of 1989)(2) Subject to paragraph (4), the medicines shall not be supplied except upon a written order signed by a duly registered medical practitioner, registered dentist, or by a person authorized to be in charge of a ward, theatre or other section of the institution.(3) The container of the medicine shall be labelled with words describing its contents. (2 of 2015 s. 40)(4) In the case of an emergency, a medicine containing a poison may be supplied without a written order if the person ordering the medicine undertakes to furnish a written order in respect of that medicine within the next 24 hours. 24. Storage of poisons in institutions (1) In any institution in which medicines are dispensed in a dispensing or pharmaceutical department in the charge of a person appointed for the purpose, all poisons other than those issued for use within the institution shall be stored in that department.(2) In any institution to which paragraph (1) does not apply all poisons other than those issued for use within the institution shall be stored—(a) in the charge of a person appointed for the purpose by the governing body or person in control of the institution; and(b) in the case of substances included in Schedule 1 either in a cupboard or drawer, or on a shelf, reserved for the storage of poisons. (2 of 2015 s. 41; E.R. 5 of 2020)(3)-(4) (Repealed 2 of 2015 s. 41)(5) All places in which poisons are required by this regulation to be stored shall be inspected at regular intervals of time not exceeding three months by a registered pharmacist or registered medical practitioner appointed for the purpose by the governing body of the institution and a record of all inspections shall be made in a book kept at the institution.(E.R. 3 of 2015) Part 5A Listed Sellers of Poisons 24A. Applications to be entered on list under section 25 (1) Any application under section 25(1) shall be made in writing to the Committee and shall be accompanied by the fee specified in Schedule 9. (E.R. 5 of 2020)(2) The Committee may grant or refuse any application under this regulation and shall notify the applicant of its decision: Provided that if the Committee intends to refuse an application the Committee shall first notify the applicant and the applicant may, not later than 14 days after the date of such notification, submit representations in writing to the Committee in support of his application. (3) Where the Committee grants an application under this regulation the Committee shall notify the Board of its decision and shall state whether the applicant has paid the prescribed fee.(4) Any applicant aggrieved by a decision made in respect of the applicant under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (2 of 2015 s. 42)(Part 5A added L.N. 369 of 1980; E.R. 3 of 2015) Part 5B Registration of Premises of Authorized Sellers of Poisons (2 of 2015 s. 73) 24B. Applications to register premises under section 13 An application to register premises under section 13 shall be—(a) (Repealed 2 of 2015 s. 43)(b) submitted together with a copy of the certificate of registration of the registered pharmacist by whom or in whose presence and under whose supervision the actual sale of poisons will be conducted under section 11(1) of the Ordinance. (2 of 2015 s. 43)(L.N. 85 of 1987) 24C. (Repealed 2 of 2015 s. 44) Part 6 Wholesale Dealing in Poisons and Pharmaceutical Products (2 of 2015 s. 73) 25. Sale and supply of poisons or pharmaceutical products wholesale A person must not, by way of wholesale dealing, sell or supply at or from any premises a pharmaceutical product, or a substance or article consisting of or containing any poison, unless the person—(a) holds a wholesale dealer licence issued to the person by the Committee in respect of those premises;(b) is an authorized seller of poisons; or(c) is a licensed manufacturer selling or supplying only pharmaceutical products manufactured by the licensed manufacturer.(2 of 2015 s. 45) 26. Pharmacy and Poisons (Wholesale Licences) Committee (1) There shall be for the purposes of this Part a Committee to be called the Pharmacy and Poisons (Wholesale Licences) Committee.(2) (Repealed L.N. 369 of 1980)(3) The Committee may, subject to any conditions it thinks fit to impose, issue a wholesale dealer licence on payment of the fee prescribed in Schedule 9. (E.R. 5 of 2020)(4) The issue of a wholesale dealer licence shall be at the discretion of the Committee and shall be in the specified form.(5) In any of the circumstances specified in paragraph (5A), the Committee may—(a) revoke a wholesale dealer licence or suspend it for a period it thinks fit;(b) issue a warning letter to the licensed wholesale dealer; or(c) vary a condition of the licence imposed under paragraph (3). (2 of 2015 s. 46)(5A) The circumstances are—(a) that, in the Committee’s opinion, the licensed wholesale dealer has contravened—(i) a condition of the licence; or(ii) any of these regulations or a code of practice applicable to the licensed wholesale dealer; or(b) that the licensed wholesale dealer has been convicted of—(i) an offence under the Ordinance or any of the regulations made under section 29, the Dangerous Drugs Ordinance (Cap. 134), the Antibiotics Ordinance (Cap. 137) or the Undesirable Medical Advertisements Ordinance (Cap. 231); or(ii) an offence under section 6C or 6D of the Import and Export Ordinance (Cap. 60), section 52, 54 or 61 of the Public Health and Municipal Services Ordinance (Cap. 132) or section 7, 7A or 9 of the Trade Descriptions Ordinance (Cap. 362). (2 of 2015 s. 46)(5B) The Committee may, subject to any conditions it thinks fit to impose, suspend for a period not exceeding 3 years (suspension period) the operation of a decision made under paragraph (5)(a) so that the decision takes effect only if a condition so imposed is contravened during the suspension period, and in the case of such a contravention, the decision takes effect on the date specified by the Committee having regard to all the circumstances of the case. (2 of 2015 s. 46)(6) Any applicant or licensed wholesale dealer aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980)(7) (Repealed L.N. 369 of 1980)(8) An applicant for a wholesale dealer licence— (2 of 2015 s. 46)(a) shall nominate in writing a responsible person to be in charge of the poisons or pharmaceutical products; and(b) may nominate in writing one or more deputies to act during the temporary absence of the responsible person.(9) An applicant shall at the time of his application submit to the Secretary the name of the person so nominated and of any deputy, and shall advise the Secretary of any change within 7 days of its occurrence.(10) If—(a) a person was issued with a wholesale poisons licence under this regulation, as in force before the commencement date* of the Pharmacy and Poisons (Amendment) Ordinance 2015 (2 of 2015) (amending Ordinance); and(b) that licence was in force immediately before that date,then, for the remainder of the period for which that licence would have continued to be valid had section 46 of the amending Ordinance not been enacted, the person is to be regarded as a licensed wholesale dealer, and the Ordinance and regulations made under section 29 apply to the person accordingly. (2 of 2015 s. 46)(2 of 2015 s. 46; E.R. 3 of 2015) Editorial Note: * Commencement Date: 6 February 2015. 27. Sales of poisons by licensed wholesale dealers or licensed manufacturers (2 of 2015 s. 47)A licensed wholesale dealer or licensed manufacturer must not sell or supply a poison to any person other than the following— (2 of 2015 s. 47)(a) a licensed wholesale dealer; (2 of 2015 s. 47)(ab) a licensed manufacturer; (2 of 2015 s. 47)(b) an authorized seller of poisons;(c) a registered pharmacist;(d) a registered medical practitioner, a registered dentist or a registered veterinary surgeon; (L.N. 614 of 1997)(e) persons who require the poison for the purpose of their trade or business;(f) a Government department or public officer requiring the article for the purposes of the public service;(g) a person or an establishment concerned with education or scientific research, if the article is required for the purposes of such education or research;(h) an institution;(i) purchasers outside Hong Kong; or(j) a listed seller of poisons, if the poison is included in the classes of poisons in Part 2 of the Poisons List that the listed seller is licensed to sell. (2 of 2015 s. 47)(E.R. 3 of 2015) 28. Records to be kept by licensed wholesale dealers or licensed manufacturers (2 of 2015 s. 48)(1) A licensed wholesale dealer or licensed manufacturer must record the following particulars for each transaction by which any poison included in Part 1 of the Poisons List or any pharmaceutical product is acquired by him whether by way of import, purchase, gift or otherwise— (L.N. 137 of 1978; 2 of 2015 s. 48)(a) the date of the transaction;(b) the name of the supplier;(c) the name of the poison or pharmaceutical product;(ca) the batch number, pack size and unit of quantity of the poison or pharmaceutical product; (2 of 2015 s. 48)(d) the total quantity of the poison or pharmaceutical product;(e) the nature of the transaction; and(f) a reference to the invoice or other documents supporting the transaction.(2) A licensed wholesale dealer or licensed manufacturer must record the following particulars for each transaction by which any poison included in Part 1 of the Poisons List or any pharmaceutical product is disposed of, whether the disposition is by way of export, sale, gift or otherwise— (L.N. 137 of 1978; 2 of 2015 s. 48)(a) the date of the transaction;(b) the nature of the transaction;(c) the name of the person to whom the poison or pharmaceutical product is supplied;(ca) for an advanced therapy product supplied for use by a registered medical practitioner or registered dentist—the name and address of the practitioner or dentist; (19 of 2020 s. 7)(d) the total quantity of the poison or pharmaceutical product;(e) a reference to the invoice or other documents supporting the transaction;(f) the name of the poison or pharmaceutical product;(fa) the batch number, pack size and unit of quantity of the poison or pharmaceutical product; (2 of 2015 s. 48)(g) the balance of the poison or pharmaceutical product remaining in his possession after the transaction.(3) For each poison in Part 1 of the Poisons List or pharmaceutical product there shall be a separate entry in the records and all transactions involving that poison or pharmaceutical product shall be entered in a part of the records reserved for that poison or pharmaceutical product.(4) Unless the Committee approves another system of recording, all records of transactions must be in the specified form.(5) Every transaction to which these regulations relate shall be recorded within 72 hours after the time it took place.(6) Records of sales or supplies maintained under this regulation shall be supported by documents signed by the purchaser.(7) In the case of an import or export transaction, the licensed wholesale dealer or licensed manufacturer must retain all shipping and other documents supporting the transaction. (L.N. 137 of 1978)(8) A licensed wholesale dealer must set up and maintain a system of control that will enable the rapid and, so far as practicable, complete recall of any lot or batch of a pharmaceutical substance or product from sale to the public in the event of the pharmaceutical substance or product being found to be dangerous or injurious to health. (L.N. 137 of 1978)(2 of 2015 s. 48; E.R. 3 of 2015) Part 7 Manufacture of Pharmaceutical Products (2 of 2015 s. 73) 28A. Good Manufacturing Practice Guide (1) The Board may issue a Good Manufacturing Practice Guide providing for the principles and guidelines of good manufacturing practice in respect of pharmaceutical products.(2) The GMP Guide—(a) may consist of a code, standard, rule, specification or any other documentary form of practical guidance prepared by the Board or any other body or authority; and(b) may apply, incorporate or refer to a document that has been formulated or published by a body or authority either as in force at the time when the document is so applied, incorporated or referred to or as amended, formulated or published from time to time.(3) If the GMP Guide is issued, the Board must by notice published in the Gazette—(a) identify the Guide; and(b) specify the date on which the Guide is to take effect.(4) The Board may from time to time revise the whole or any part of the GMP Guide.(5) If the GMP Guide is revised, the Board must by notice published in the Gazette—(a) identify the Guide or part revised; and(b) specify the date on which the revision is to take effect.(6) The Board must make a copy of the GMP Guide available for inspection by the public free of charge—(a) at the office of the Secretary during normal office hours; and(b) in any other manner the Board thinks fit.(7) The GMP Guide, and a notice published under paragraph (3) or (5), are not subsidiary legislation.(2 of 2015 s. 49) 29. Licensing of manufacturers (1) A person must not manufacture any pharmaceutical product on any premises unless he is the holder of a licence to manufacture pharmaceutical products on those premises.(1A) For the purposes of paragraph (1), a person is not regarded as manufacturing a pharmaceutical product only by affixing to the container of the product a label—(a) that does not state any of the following particulars—(i) particulars mentioned in regulation 31(1)(a), (b), (e), (f) or (g); (19 of 2020 s. 8)(ii) particulars regarding the dosage, route or frequency of administration of the product;(iii) the name of the product; and(b) that does not obscure, change or obliterate any of the following particulars labelled on the container—(i) particulars mentioned in subparagraph (a);(ii) particulars mentioned in regulation 31(1)(c). (2 of 2015 s. 50)(2) (Repealed 2 of 2015 s. 50)(3) The Committee may, subject to any conditions it thinks fit to impose, issue a licence to manufacture pharmaceutical products in the specified form on payment of the fee prescribed in Schedule 9. (E.R. 5 of 2020)(4) In any of the circumstances specified in paragraph (4A), the Committee may—(a) revoke a licence to manufacture pharmaceutical products or suspend it for a period it thinks fit;(b) issue a warning letter to the licensed manufacturer; or(c) vary a condition of the licence imposed under paragraph (3). (2 of 2015 s. 50)(4A) The circumstances are—(a) that, in the Committee’s opinion, the licensed manufacturer has contravened—(i) a condition of the licence or any of these regulations; or (ii) a code of practice applicable to the licensed manufacturer or the GMP Guide; or(b) that the licensed manufacturer has been convicted of—(i) an offence under the Ordinance or any of the regulations made under section 29, the Dangerous Drugs Ordinance (Cap. 134), the Antibiotics Ordinance (Cap. 137) or the Undesirable Medical Advertisements Ordinance (Cap. 231); or(ii) an offence under section 6C or 6D of the Import and Export Ordinance (Cap. 60), section 52, 54 or 61 of the Public Health and Municipal Services Ordinance (Cap. 132) or section 7, 7A or 9 of the Trade Descriptions Ordinance (Cap. 362). (2 of 2015 s. 50)(4B) The Committee may, subject to any conditions it thinks fit to impose, suspend for a period not exceeding 3 years (suspension period) the operation of a decision made under paragraph (4)(a) so that the decision takes effect only if a condition so imposed is contravened during the suspension period, and in the case of such a contravention, the decision takes effect on the date specified by the Committee having regard to all the circumstances of the case. (2 of 2015 s. 50)(5) For the purpose of certifying that a manufacturer is licensed under this regulation, the Committee, subject to any conditions it may impose and to the payment of the fee prescribed in Schedule 9, may issue to the manufacturer— (E.R. 5 of 2020)(a) a certificate for manufacture; or(b) an interim-certificate for manufacture,in the specified forms.(6) For the purpose of exporting pharmaceutical products manufactured by a licensed manufacturer, the Committee may, subject to any conditions it may impose and to the payment of the fee prescribed in Schedule 9, issue to the manufacturer— (2 of 2015 s. 50; E.R. 5 of 2020)(a) a free sale certificate of pharmaceutical product; or(b) a certificate of pharmaceutical product,in the specified forms. (L.N. 449 of 1991)(7) Any applicant or licensed manufacturer aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980)(L.N. 369 of 1980; 2 of 2015 s. 50; E.R. 3 of 2015) 30. Manufacture to be under supervision of a registered pharmacist (1) In all premises in which pharmaceutical products are manufactured such products shall be manufactured by or under the supervision of—(a) a registered pharmacist; or (2 of 2015 s. 51)(b) (Repealed 2 of 2015 s. 51)(c) a person having such other qualifications or sufficient experience as may be approved by the Board.(2) For the purposes of paragraph (1), supervision (監督) means the exercise by any of the persons referred to in paragraph (1) of control over the process of manufacture and of the persons engaged therein. (L.N. 137 of 1978) 30A. Authorized person to certify compliance with GMP Guide etc. (1) A licensed manufacturer must ensure that at least one authorized person is employed to be responsible for carrying out, in relation to the pharmaceutical products manufactured under the licence, the duties specified in paragraph (2).(2) An authorized person is responsible for ensuring and certifying that—(a) each batch of the pharmaceutical products has been manufactured and checked in accordance with the GMP Guide; and(b) the registrable particulars of each batch of the pharmaceutical products correspond exactly with the registered particulars of the products.(3) In this regulation—registered particulars (註冊詳情) has the meaning given by regulation 35A;registrable particulars (須註冊詳情) has the meaning given by regulation 35A.(2 of 2015 s. 52) 30B. Register of authorized persons (1) The Board must cause the Secretary to keep a register of authorized persons for the purposes of these regulations.(2) The register may be kept in a form the Board thinks fit.(3) The register must contain, for each person who is registered as an authorized person under this Part—(a) the name and address of the person; and(b) any other particulars of the person the Board thinks fit.(4) The Board may amend the register as to the name, address or any other particulars relating to an authorized person whose name appears in the register on being satisfied that the amendment is necessary for preserving the accuracy of the register.(5) The Secretary must make the register available for inspection by the public free of charge at the office of the Secretary during normal office hours, and in any other manner the Secretary thinks fit, so as to enable a member of the public—(a) to ascertain whether a person is an authorized person; and(b) to ascertain the particulars of the registration of the person.(2 of 2015 s. 52) 30C. Application for registration as authorized person (1) A person who satisfies the requirements specified in paragraph (2) may apply to the Committee for registration as an authorized person.(2) The requirements are that—(a) the person—(i) is a registered pharmacist; or(ii) holds a qualification awarded on completion of a course recognized by the Committee; and(b) the person—(i) has at least 3 years’ relevant experience in Hong Kong or a place outside Hong Kong in manufacturing pharmaceutical products in accordance with the GMP Guide or a document similar or equivalent to that Guide issued or adopted by a competent authority of a place outside Hong Kong;

or(ii) meets any other criteria that the Committee may specify.(3) The application must be in the specified form.(4) The Committee may require the applicant to provide any information or document that the Committee considers reasonably necessary for determining the application.(2 of 2015 s. 52) 30D. Registration as authorized person (1) The Committee must decide whether to grant or refuse an application for registration made under regulation 30C.(2) The Committee may grant an application on being satisfied that the applicant is a fit and proper person to be registered as an authorized person.(3) A registration under this regulation is subject to any conditions the Committee thinks fit to impose.(4) On registration, the Committee must issue to the applicant a certificate of registration in the specified form on payment of the fee prescribed in Schedule 9. (E.R. 5 of 2020)(5) Subject to regulation 30F, a registration has effect from the date on which the certificate of registration is issued until the end of the year in which the date falls.(6) An applicant aggrieved by a decision made in respect of the applicant under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision.(2 of 2015 s. 52; E.R. 3 of 2015) 30E. Renewal of registration of authorized person (1) The Committee may, on an application, renew the registration of an authorized person.(2) An application for renewal of registration must be in the specified form.(3) The Committee may require the applicant to provide any information or document that the Committee considers reasonably necessary for determining the application.(4) A registration renewed under this regulation is subject to any conditions the Committee thinks fit to impose.(5) On renewal of registration, the Committee must issue to the applicant a renewed certificate of registration in the specified form on payment of the fee prescribed in Schedule 9. (E.R. 5 of 2020)(6) Subject to regulation 30F, a renewed registration has effect from the date on which the renewed certificate of registration is issued until the end of the year in which the date falls.(7) An applicant aggrieved by a decision made in respect of the applicant under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision.(2 of 2015 s. 52; E.R. 3 of 2015) 30F. Cancellation or suspension etc. of registration as authorized person (1) The Committee may exercise any one or more of the following powers in any of the circumstances specified in paragraph (2) in respect of a person registered as an authorized person under this Part—(a) cancel the registration;(b) suspend the registration for a period specified by the Committee;(c) issue a warning letter to the person;(d) vary a condition of the registration imposed under regulation 30D(3) or 30E(4).(2) The circumstances are—(a) that the Committee is satisfied that the person is no longer a fit and proper person to be registered as an authorized person;(b) that in the Committee’s opinion, the person has contravened—(i) a condition of the registration; or(ii) any of these regulations or a code of practice applicable to the person as an authorized person; or(c) that the person has been convicted of—(i) an offence under the Ordinance or any of the regulations made under section 29, the Dangerous Drugs Ordinance (Cap. 134), the Antibiotics Ordinance (Cap. 137) or the Undesirable Medical Advertisements Ordinance (Cap. 231); or(ii) an offence under section 52, 54 or 61 of the Public Health and Municipal Services Ordinance (Cap. 132) or section 7, 7A or 9 of the Trade Descriptions Ordinance (Cap. 362).(3) The Committee may, subject to any conditions it thinks fit to impose, suspend for a period not exceeding 3 years (suspension period) the operation of a decision made under paragraph (1)(a) or (b) so that the decision takes effect only if a condition so imposed is contravened during the suspension period, and in the case of such a contravention, the decision takes effect on the date specified by the Committee having regard to all the circumstances of the case.(4) The Committee must cause the Secretary to—(a) as soon as practicable after cancelling a person’s registration under paragraph (1)(a), remove the entries relating to the person from the register of authorized persons; or(b) as soon as practicable after suspending a person’s registration under paragraph (1)(b), remove the entries relating to the person from the register of authorized persons, and restore those entries to the register as soon as practicable after the period of suspension expires.(5) A person whose registration as an authorized person is cancelled must immediately return to the Committee the certificate of registration or renewed certificate of registration issued to the person under regulation 30D or 30E.(6) A person mentioned in paragraph (1) who is aggrieved by a decision made in respect of the person under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision.(2 of 2015 s. 52) 31. Labelling by licensed manufacturers (2 of 2015 s. 53)(1) Subject to paragraph (4), a licensed manufacturer shall label or cause to be labelled the container of each pharmaceutical product, with the following particulars— (2 of 2015 s. 53)(a) the appropriate designation of—(i) the substance or substances from which the pharmaceutical product was manufactured;(ii) each of the active constituents of the product; or(iii) each of the ingredients from which the product was compounded;(b) in the case where the appropriate designation of each of the active constituents or ingredients of a product is given, the appropriate quantitative particulars of those constituents or ingredients;(c) the name and address of the manufacturer; (2 of 2015 s. 53)(d) for a pharmaceutical product registered under regulation 36—the number of the registration certificate issued under regulation 36(5); (19 of 2020 s. 9)(e) the batch number of the pharmaceutical product; (2 of 2015 s. 53; 19 of 2020 s. 9)(f) the expiry date of the pharmaceutical product; (2 of 2015 s. 53; 19 of 2020 s. 9)(g) for an advanced therapy product—(i) the product code, and the unique donation identifier, assigned in accordance with the codes of practice issued by the Board; and(ii) if the product is for autologous use only—(A) the unique recipient identifier assigned in accordance with the codes of practice issued by the Board; and(B) the English words “For autologous use only” or the Chinese characters “只供自體使用”. (19 of 2020 s. 9)(2) For the purposes of paragraph (1)—(a) the expression appropriate designation (適當稱號), in relation to a substance, constituent or ingredient, means— (i) in the case of a poison included in the Poisons List, the name with which the container of the poison is for the time being required to be labelled in accordance with regulation 13; (ii) in the case where a substance, constituent or ingredient is not a poison and is described in any of the monographs contained in the edition of the British Pharmacopoeia, the British Pharmaceutical Codex or the British Veterinary Codex which was last published before the date on which the article was sold or supplied, the description set out at the head of that monograph; and (iii) in any other case the accepted scientific name or the name descriptive of the true nature and origin of the substance, constituent or ingredient; (b) the expression appropriate quantitative particulars (適當數量詳情), in relation to the active constituent or ingredient of a pharmaceutical product, means— (i) the percentage or quantity of that constituent or ingredient contained in the pharmaceutical product sold or supplied; or (ii) in the case of a pharmaceutical product which is in pill, capsule, tablet or similar article, either the percentage or quantity of the substance or substances comprising or forming part of the pills, capsules, tablets or similar articles, or the quantity of each constituent or ingredient in each pill, capsule, tablet or article; (2 of 2015 s. 53) (c) batch number (批次編號), in relation to a pharmaceutical product, means a unique combination of numbers, letters or other symbols from which— (i) the batch or lot to which the product belongs can be identified; and (ii) the production and distribution history of the product can be determined. (2 of 2015 s. 53; 19 of 2020 s. 9) (d) (Repealed 19 of 2020 s. 9)(3) For the purposes of paragraph (1) the container to be labelled shall, where the pharmaceutical product is packed by the manufacturer in more than one container, be the container which is likely to be sold or distributed to the ultimate user of the product.(4) In the case of a pharmaceutical product intended for export it shall be a sufficient compliance with this regulation if the container of the product is labelled with the following particulars—(a) the name and address of the manufacturer; and(b) such other details as the importing country may require. (L.N. 137 of 1978) 32. Manufacturing workers not to infect products A licensed manufacturer must take adequate steps to ensure that every person engaged in the manufacturing of pharmaceutical products does not contaminate or infect such products.(2 of 2015 s. 54) 33. Duties of licensed manufacturers regarding identity, purity, safety, etc. (2 of 2015 s. 55)(1) Subject to paragraph (1A), a licensed manufacturer must test each lot or batch of raw or bulk material intended to be used in the manufacture of pharmaceutical products to ensure identity and purity. (L.N. 137 of 1978)(1A) Raw or bulk material the identity and purity of which the manufacturer thereof has certified by a certificate of analysis does not require a test by a licensed manufacturer under paragraph (1). (L.N. 137 of 1978)(2) A licensed manufacturer must ensure that the registrable particulars of each batch of pharmaceutical products in a finished form correspond exactly with the registered particulars of the products. (2 of 2015 s. 55)(3) Every parenteral product shall be manufactured in accordance with the method of preparation of injections laid down by the British Pharmacopoeia or other Pharmacopoeia with which the particular product is intended to comply.(4) Unless paragraph (4B) or (4D) applies, a licensed manufacturer must retain a control sample of each batch of finished products under conditions of storage suitable to that product for a period of not less than 1 year after the expiry date of the product. (L.N. 137 of 1978; 19 of 2020 s. 10)(4A) Paragraph (4B) applies to a licensed manufacturer in respect of a batch of pharmaceutical products if all of the following conditions are satisfied—(a) the products are enclosed in a primary container in which the products are to be sold or supplied;(b) the process of manufacture that the manufacturer carries out, in respect of the products, only involves one or more of the following—(i) adding a package insert;(ii) replacing a package insert;(iii) (if the products are intended for export) affixing a label to any labelled container of the products, and the label does not obscure, change or obliterate any of the following particulars appearing on that labelled container—(A) particulars required to be labelled under regulation 31(4);(B) the name of the products;(C) the batch number of the products;(D) the expiry date of the products;(iv) (if the products are not intended for export) affixing a label to any labelled container of the products, and the label does not obscure, change or obliterate any of the following particulars appearing on that labelled container—(A) the registered particulars of the products;(B) the batch number of the products;(C) the expiry date of the products;(c) throughout the process of manufacture, the primary container remains closed. (2 of 2015 s. 55)(4B) The manufacturer is only required to retain a sample of the following of the batch of finished products for a period of not less than 1 year after the expiry date of the products—(a) if paragraph (4A)(b)(i) applies, the package insert added;(b) if paragraph (4A)(b)(ii) applies, the replacing package insert;(c) if paragraph (4A)(b)(iii) or (iv) applies, the label affixed. (2 of 2015 s. 55)(4C) Paragraph (4D) applies to a licensed manufacturer of an advanced therapy product containing or consisting of cells or tissues. (19 of 2020 s. 10)(4D) The manufacturer is only required to keep photographs that clearly present the particulars mentioned in regulation 31(1) of each batch of finished products for a period of not less than 1 year after the expiry date of the products. (19 of 2020 s. 10)(5) A licensed manufacturer must set up and maintain a system of control that will enable the rapid and, so far as practicable, complete recall of any lot or batch of a pharmaceutical substance or product from sale to the public in the event of the pharmaceutical substance or product being found to be dangerous or injurious to health. (L.N. 137 of 1978)(6) Despite paragraphs (4), (4B)(c) and (4D), a licensed manufacturer is not required to comply with paragraph (4), (4B)(c) or (4D) (as applicable) in respect of a batch of pharmaceutical products if the manufacturer is not regarded as manufacturing the products for the purposes of regulation 29(1). (2 of 2015 s. 55; 19 of 2020 s. 10)(7) In this regulation—batch number (批次編號) has the meaning given by regulation 31(2)(c); labelled container (帶標籤容器), for a pharmaceutical product, means a container of the product on which the following particulars appear— (a) the name of the product; (b) the batch number of the product; (c) the expiry date of the product; package insert (包裝附頁) has the meaning given by regulation 36(3A);primary container (最內層容器), for a pharmaceutical product, means the container that is in direct contact with the product;registered particulars (註冊詳情) has the meaning given by regulation 35A;registrable particulars (須註冊詳情) has the meaning given by regulation 35A. (2 of 2015 s. 55)(2 of 2015 s. 55; 19 of 2020 s. 10) 34. Licensed manufacturer’s premises (2 of 2015 s. 56)(1) No pharmaceutical product shall be manufactured unless the premises and the fittings and machinery therein used in the manufacturing of such product are of such construction, materials and finish as to— (2 of 2015 s. 56)(a) permit the ready and efficient cleaning of all surfaces; and(b) avoid the contamination of the product during manufacture. (2 of 2015 s. 56)(2) All premises used in the manufacturing, testing and despatch of pharmaceutical products shall be— (2 of 2015 s. 56)(a) suitable for the purpose; and(b) maintained in a clean and orderly condition.(3) The temperature and humidity of the premises shall be controlled as appropriate to the manufacture of the product or the process being carried out therein.(4) All parenteral products shall be manufactured and put into containers in an enclosed area in which aseptic conditions can be maintained.(5) The enclosed area referred to in paragraph (4) shall be separate from the areas used for the manufacture of other pharmaceutical products. (2 of 2015 s. 56) 35. Records to be kept by licensed manufacturers (2 of 2015 s. 57)(1) A licensed manufacturer must maintain adequate records in respect of each pharmaceutical product prepared by him, showing— (2 of 2015 s. 57)(a) the quantities of all substances used in the manufacture of the product;(b) the quantity of the product manufactured;(c) the name and the address of the person to whom the pharmaceutical product was sold or supplied;(ca) for an advanced therapy product sold or supplied for use by a registered medical practitioner or registered dentist—the name and address of the practitioner or dentist; (19 of 2020 s. 11)(d) the nature and results of tests made on each lot or batch of raw or bulk materials used in the product;(e) the nature and results of tests made on each batch of finished product;(f) any complaints received relating to the product and the action taken on the complaints by the manufacturer; (g) the nature and result of any tests made on the samples retained; and (L.N. 228 of 1975)(h) for an advanced therapy product containing or consisting of cells or tissues—(i) the name and address of the person from whom the cells or tissues used for the preparation of the product were obtained; and(ii) the unique donation identifier assigned in accordance with the codes of practice issued by the Board. (19 of 2020 s. 11)(2) A record showing the matters mentioned in paragraph (1)(a), (b), (d), (e), (g) or (h) must be completed when the manufacturing process or test concerned is being carried out. (2 of 2015 s. 57)(3) A record showing the matters mentioned in paragraph (1)(c) or (ca) must be completed within 72 hours after the transaction concerned takes place. (2 of 2015 s. 57)(4) For the purposes of paragraph (1)(f)—(a) a record showing a complaint must be completed within 72 hours after the complaint is received by the licensed manufacturer; and(b) a record showing an action taken in respect of a complaint must be completed within 72 hours after the action is taken. (2 of 2015 s. 57)(19 of 2020 s. 11) Part 8 Registration of Pharmaceutical Products and Substances 35A. Interpretation (Part 8) In this Part, unless the context otherwise requires—additional particulars (附加詳情), in relation to a pharmaceutical product or substance registered before the commencement date, means those registrable particulars of the product or substance not referred to in the repealed regulation 36(3);commencement date (生效日期) means the commencement date* of section 4 of the Pharmacy and Poisons (Amendment) (No. 2) Regulation 1995 (L.N. 366 of 1995); registered particulars (註冊詳情) means— (a) in relation to a pharmaceutical product or substance registered before the commencement date—(i) such of its particulars as are registered under the repealed regulation 36(3); and(ii) its additional particulars as contained in or ascertainable from the application form, the relevant literature and supporting documents (if any) submitted to the Committee for the purpose of the registration of the product or substance, or as contained in or ascertainable from the specimen sales packs or samples (or prototypes of the packs and proposed wordings of the labels) made available for inspection by the Committee for the purpose of the registration of the product or substance; (b) in relation to a pharmaceutical product or substance registered on or after the commencement date, its registrable particulars as registered under regulation 36(3), or in either case, where from time to time any subsequent approval has been given by the Board or the Committee to change any of the registrable particulars of the product or substance as from a certain date, then as from that date, its said particulars changed in accordance with such approval; registered product or substance (註冊製品或物質) means any pharmaceutical product or substance which is the subject of a valid registration certificate issued under regulation 36(5);registrable particulars (須註冊詳情), in relation to a pharmaceutical substance, means the particulars referred to in regulation 36(3)(a), and, in relation to a pharmaceutical product, means all of the particulars referred to in regulation 36(3)(a) and (b);repealed regulation 36(3) (已廢除的第36(3)條) means the regulation 36(3) which was in force immediately before the commencement date.(L.N. 366 of 1995; E.R. 3 of 2015) Editorial Note: * Commencement date: 28 July 1995. 36. Registration of pharmaceutical products and substances (1) Subject to paragraphs (1A), (1B) and (1C), no person shall sell, offer for sale or distribute or possess for the purposes of sale, distribution or other use any pharmaceutical product or substance unless the product or substance is registered with the Board— (L.N. 85 of 1987; L.N. 366 of 1995)(a) by the licensed manufacturer, or a licensed wholesale dealer who has entered into a contract with the licensed manufacturer under which the licensed manufacturer is required to manufacture the pharmaceutical product or substance, if the pharmaceutical product or substance is manufactured in Hong Kong;(b) by a person referred to in section 28A(1) or (3) who imports the pharmaceutical product or substance into Hong Kong, if the pharmaceutical product or substance is manufactured outside Hong Kong; or(c) by the local branch, subsidiary, representative, agent or distributor of a manufacturer outside Hong Kong. (L.N. 137 of 1978; 23 of 1998 s. 2; 2 of 2015 s. 58)(1A) Nothing in paragraph (1) shall apply in the case of possession or use where the pharmaceutical product or substance—(a) has been imported into Hong Kong—(i) to be exported outside Hong Kong; or (2 of 2015 s. 58)(ii) by a licensed manufacturer for the purpose of manufacture or the compounding of pharmaceutical preparations; (2 of 2015 s. 58)(iii) (Repealed 2 of 2015 s. 58)(ab) is possessed or is to be used for the purpose of treatment by a registered medical practitioner or a registered dentist of a particular patient or for the purpose of treatment by a registered veterinary surgeon of a particular animal; (2 of 2015 s. 58)(b) has been manufactured in Hong Kong to be exported outside Hong Kong; (L.N. 85 of 1987; 2 of 2015 s. 58)(c) is to be administered for the purposes of a clinical trial that is to be conducted in accordance with a clinical trial certificate issued under regulation 36B(3); or (2 of 2015 s. 58)(d) is to be administered for the purposes of a medicinal test that is to be conducted in accordance with a medicinal test certificate issued under regulation 36B(3). (2 of 2015 s. 58)(1B) For the avoidance of any doubt, a pharmaceutical product or substance is registered with the Board, for the purposes of paragraph (1), if and only if its registrable particulars are those which correspond exactly with the registered particulars of a registered product or substance. (L.N. 366 of 1995)(1C) It shall be a defence to a charge against any person for contravening paragraph (1) if the person proves that he did not know and could not with reasonable diligence have discovered that the product or substance was not registered with the Board. (L.N. 366 of 1995)(2) Application for the initial registration of a pharmaceutical product or substance shall be made in the specified form and shall be accompanied by the fee prescribed in Schedule 9. (2 of 2015 s. 58; E.R. 5 of 2020)(2A) In considering an application for registration of a pharmaceutical product which contains as active ingredients any Chinese herbal medicines or proprietary Chinese medicines as defined in section 2 of the Chinese Medicine Ordinance (Cap. 549) or other materials of herbal, animal or mineral origin customarily used by the Chinese for medicinal purpose, the Board shall seek advice from the Chinese Medicines Board established under the Chinese Medicine Ordinance (Cap. 549). (47 of 1999 s. 175)(3) The particulars to be registered shall—(a) in the case of a product or substance, be—(i) its name;(ii) its specifications;(iii) its label;(iv) its package insert, if any;(v) the name and address of the manufacturer; and(vi) the name and address of the applicant;(b) in the case of a product, further be—(i) its dose form;(ii) the quantity or quantities of the dose form contained in its unit package or unit packages;(iii) the name and quantity of all its active ingredients;(iv) the name and quantity of all its excipients; and(v) its proposed indication, dosage and route of administration. (L.N. 366 of 1995)(3A) For the purposes of paragraph (3)—active ingredient (有效成分) means an ingredient of the product which is not an excipient;excipient (賦形劑) means an ingredient of the product which does not contribute to its pharmacological action or which so contributes only by regulating the release of an active ingredient;label (標籤) means any statement forming part of or affixed to the container or package of the product or substance;package insert (包裝附頁) means any leaflet, notification or other document supplied with the container or package of the product or substance, but does not include a label. (L.N. 366 of 1995)(4) Prototypes of the sales packs, and proposed wordings of the labels, of the product or substance must be made available for inspection by the Committee. (19 of 2020 s. 12)(5) The Committee may, subject to any conditions it thinks fit to impose, register a pharmaceutical product or substance by issuing to the applicant a registration certificate in the specified form and the certificate is valid for a period of 5 years from the date of registration on payment of the fee prescribed in Schedule 9. (2 of 2015 s. 58; E.R. 5 of 2020)(6) The Committee shall advise the applicant whether the pharmaceutical product or substance appears in the Poisons List and if so, under which classification.(7) A registration certificate issued under paragraph (5) shall be renewable on— (2 of 2015 s. 58)(a) payment of the fee prescribed in Schedule 9; and (E.R. 5 of 2020)(b) providing the Committee with the up-to-date information specified by the Committee regarding the pharmaceutical product or substance. (2 of 2015 s. 58)(7A) A renewal under paragraph (7) is subject to any conditions the Committee thinks fit to impose. (2 of 2015 s. 58)(7B) The Committee may vary a condition imposed under paragraph (5) or (7A) if it thinks fit to do so. (2 of 2015 s. 58)(8) The Committee may deregister a pharmaceutical product or substance, suspend the registration of a pharmaceutical product or substance for a period specified by the Committee, or issue a warning letter to the holder of a registration certificate, if it is of the opinion that a condition of the registration is contravened or if it considers it to be in the public interest to do so. (2 of 2015 s. 58)(8A) Where the Committee refuses to register or deregisters a pharmaceutical product or substance it shall forward to the applicant or permit holder, as the case may be, a notice of refusal or of deregistration and shall state in such notice its reasons for refusal to register or for deregistration. (L.N. 137 of 1978)(9) Any applicant or holder of a registration certificate aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980; 2 of 2015 s. 58)(10) (Repealed L.N. 369 of 1980)(11) (Repealed L.N. 366 of 1995)(L.N. 137 of 1978; L.N. 369 of 1980; E.R. 3 of 2015) 36A. Application for approval to change the registered particulars of a registered product or substance (1) In this regulation—person responsible for registering a registered product or substance (負責將註冊製品或物質註冊的人) means a person who, in relation to the product or substance, belongs to any one of the classes of person described in regulation 36(1)(a), (b) or (c).(2) The person responsible for registering a registered product or substance may apply in writing to the Committee for approval to change any of the registrable particulars of the product or substance except the particulars referred to in regulation 36(3)(a)(i) and (b)(i) and (iii).(3) A person responsible for registering a registered product or substance who proposes to change the particulars referred to in regulation 36(3)(a)(i) or (b)(i) or (iii) may apply under regulation 36 for registering, as a separate product or substance, as the case may be, the product or substance with the particulars changed as proposed.(4) In dealing with an application under paragraph (2)—(a) the Committee shall take into consideration the safety, efficacy and quality of the pharmaceutical product or substance with its particulars changed as proposed, and in considering such safety and efficacy, the Committee shall observe the requirements of regulation 37(2); and(b) regulation 37(3) shall apply to such application as if it were an application for initial registration of the pharmaceutical product or substance with the particulars changed as proposed.(5) The Committee shall advise the applicant in writing whether the change is approved, and where the Committee refuses to approve a change it shall state its reasons for such refusal.(6) Where the change is approved, it shall be approved to take effect from a certain date, and the following provisions shall apply—(a) as from that date, and without limiting the generality of regulation 36(1B), the product or substance having as its registrable particulars the registered particulars which are to be changed (hereinafter referred to as the product or substance to be replaced) shall not be regarded as registered with the Board;(b) the applicant shall, prior to that date, recall or cause to be recalled any product or substance to be replaced which may still be in the possession of any person to whom he supplied the product or substance;(c) where the product or substance to be replaced is to be recalled, the applicant shall, as soon as reasonably possible, replace or cause to be replaced such product or substance with the product or substance having the particulars changed as approved, or make such alternative arrangements as are agreed with the person to whom he supplied the product or substance.(7) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision.(L.N. 366 of 1995) 36B. Clinical trials and medicinal tests (1) A person must not conduct a clinical trial on human beings, or cause or permit such a trial to be conducted, except in accordance with a clinical trial certificate issued to the person under paragraph (3). (2 of 2015 s. 59)(1A) A person must not conduct a medicinal test on animals, or cause or permit such a test to be conducted, except in accordance with a medicinal test certificate issued to the person under paragraph (3). (2 of 2015 s. 59)(1B) A person who contravenes paragraph (1) or (1A) commits an offence and is liable to a fine at level 2. (2 of 2015 s. 59)(1C) For the purpose of conducting a clinical trial on human beings or a medicinal test on animals, application shall be made in writing to the Committee and shall be accompanied by the fee prescribed in Schedule 9. (E.R. 5 of 2020)(2) A copy of the protocol for the trial or test shall accompany the application.(3) The Committee may, subject to any conditions it thinks fit to impose, issue a clinical trial certificate or medicinal test certificate in the specified form and the certificate is valid for a period not exceeding 5 years on payments of the fee prescribed in Schedule 9. (E.R. 5 of 2020)(3A) The Committee may vary a condition imposed under paragraph (3) if it thinks fit to do so. (2 of 2015 s. 59)(3B) The Committee may cancel a clinical trial certificate or medicinal test certificate, suspend it for a period specified by the Committee, or issue a warning letter to the holder of the certificate, if—(a) it is of the opinion that the holder of the certificate has contravened a condition of the certificate; or(b) it considers it to be in the public interest to do so. (2 of 2015 s. 59)(3C) If the Committee refuses an application under paragraph (1C), the Committee must give the applicant a notice of refusal and state in the notice the reasons for refusal. (2 of 2015 s. 59)(3D) If the Committee decides to cancel or suspend a certificate under paragraph (3B), the Committee must give the holder of the certificate a notice of cancellation or suspension (as the case may be) and state in the notice the reasons for its decision. (2 of 2015 s. 59)(4) Any applicant or holder of a clinical trial certificate or medicinal test certificate aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980)(L.N. 137 of 1978; L.N. 369 of 1980; 2 of 2015 s. 59; E.R. 3 of 2015) 36C. Definition of pharmaceutical product and substance for the purposes of this Part For the purposes of this Part, pharmaceutical product (藥劑製品) and substance (物質) have the meaning assigned to pharmaceutical product and medicine in the Ordinance.(L.N. 137 of 1978; E.R. 5 of 2020) 36D. Duplicate certificates (1) The Committee may issue a duplicate of any certificate issued under this Part if the Committee is satisfied that the original certificate has been lost or destroyed or that for other good reason such duplicate ought to be issued.(2) A duplicate certificate issued under this regulation shall be certified in such manner as the Committee may determine.(3) There shall be payable in respect of any duplicate certificate issued under this regulation the fee prescribed in respect thereof in Schedule 9. (E.R. 5 of 2020)(L.N. 369 of 1980; E.R. 3 of 2015) 37. Factors relevant to determination of application for registration (1) In dealing with an application for initial registration of a pharmaceutical product or substance the Committee shall in particular take into consideration—(a) the safety of the pharmaceutical product or substance to which the application relates;(b) the efficacy of the pharmaceutical product or substance for the purposes for which the product or substance is proposed to be administered; and(c) the quality of the pharmaceutical product or substance according to the specification and the method or proposed method of manufacture of the product or substance, and the provisions proposed for securing that the product or substance as sold or supplied will be of that quality.(2) In taking into consideration the efficacy for a particular purpose of a pharmaceutical product or substance to which such an application relates, the Committee shall leave out of account any question whether a pharmaceutical product or substance of another description would or might be equally or more efficacious for that purpose: Provided that nothing in this paragraph shall be construed as requiring the Committee, in considering the safety of a pharmaceutical product or substance of a particular description, in relation to a purpose for which it is proposed to be administered, to leave out of account any question whether a pharmaceutical product or substance of another description, being equally or more efficacious for that purpose, would or might be safer in relation to that purpose. (E.R. 5 of 2020) (3) In dealing with an application made in respect of a pharmaceutical product or substance manufactured outside Hong Kong, the Committee shall also take into consideration in particular the methods, standards and conditions of manufacture of the pharmaceutical product or substance in respect of which application is made and may, if it thinks fit, require the applicant to take any or all of the following actions— (2 of 2015 s. 60)(a) produce an undertaking, given by the manufacturer of any such products or substances, to permit the premises where they are to be manufactured, and the operations carried on or to be carried on in the course of manufacturing them, to be inspected by or on behalf of the Committee; (2 of 2015 s. 60)(b) produce a declaration, given by or on behalf of the manufacturer of any such products or substances, that, in relation to the manufacture of these products any requirements imposed by or under the law of the country in which they are or are to be manufactured have been or will be complied with; (2 of 2015 s. 60)(c) pay a fee determined by the Committee as representing the expenditure incurred, or likely to be incurred, by or on behalf of the Committee in carrying out an inspection mentioned in subparagraph (a). (2 of 2015 s. 60)(4) The Committee shall make arrangements for the separate processing of an application for the registration of a new pharmaceutical product or new substance so that its registration shall not be unduly delayed. (L.N. 137 of 1978)(5) For the purposes of paragraph (4), new pharmaceutical product (新藥劑製品) and new substance (新物質) mean a medicine containing an active ingredient, or a substance, having a chemical formula which has not previously been marketed or registered in Hong Kong under some other name or description. (L.N. 137 of 1978; L.N. 235 of 1996; E.R. 5 of 2020)(L.N. 369 of 1980) Part VIIIA (Repealed 2 of 2015 s. 61) 37A. (Repealed 2 of 2015 s. 61) Part 9 Sale of Medicines 38. Disclosure of composition of medicines (1) Subject to these regulations, no person shall—(a) sell any article consisting of or comprising a substance recommended as a medicine; or(b) supply any such article as a sample for the purpose of inducing persons to buy the substances of which it consists or which it comprises,unless—(i) the article is labelled as required under regulation 31; or(ii) the particulars specified under regulation 31(1) are printed so as to be clearly legible in English or Chinese on the article or a label affixed thereto. (L.N. 137 of 1978)(2) Nothing in this regulation shall apply to any article—(a) made up and supplied for the use of a particular person, being an article prescribed by reference to the needs of that person; or(b) consisting wholly of either—(i) a product resulting solely from the pharmaceutical treatment of natural products as referred to by the Chinese Herbal Materia Medica;(ii) a mixture the sole ingredients of which are two or more of such products; or(iii) a natural mineral water or an artificial imitation thereof.(3) For the purposes of this regulation—advertisement (廣告) includes any notice, circular, pamphlet, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light or sound;proprietary designation (所有人稱號), in relation to the sale of an article consisting of or comprising a substance recommended as a medicine, means words used or proposed to be used in connexion with the sale of articles consisting of or comprising the substance, for the purpose of indicating that they are the goods of a particular person by virtue of manufacture, selection, certification, dealing with or offering for sale; and proprietor (所有人) in relation to such a designation means the person whose goods are indicated or intended to be indicated by the designation;substance (物質) includes a preparation;substance recommended as a medicine (建議作為藥物的物質), in relation to the sale of an article consisting or comprising a substance so recommended, means a substance which is referred to—(a) on the article, or on any wrapper or container in which the article is sold, or on any label affixed to, or in any document enclosed in, the article or such wrapper or container; or(b) in any placard or other document exhibited at the place where the article is sold; or(c) in any advertisement published after the coming into operation of these regulations by or on behalf of the manufacturer of the article, or the person carrying on the business in the course of which the article was sold, or, in a case where the article was under a proprietary designation, the proprietor of the designation,in terms which are calculated to lead to the use of the substance for the prevention or treatment of any ailment, infirmity or injury affecting the human body, not being terms which give a definite indication that the substance is intended to be used as, or as part of, a food or drink, and not as, or as part of, a medicine. 38A. Labelling of certain medicines (1) No person shall sell or supply any medicine unless it is labelled with particulars printed so as to be clearly legible in English and Chinese, as to dosage and the route and frequency of administration.(2) This regulation shall not apply to medicine that is included in Part 1 of the Poisons List or in the Schedule to the Antibiotics Regulations (Cap. 137 sub. leg. A).(L.N. 85 of 1987; E.R. 3 of 2015) Part 10 Miscellaneous 38B. Power to specify forms (1) An executive committee established under section 4A for a provision of these regulations may specify forms to be used for that provision.(2) If a form is specified under this regulation, the Board must make copies of the form available for inspection by the public free of charge—(a) at the office of the Secretary during normal office hours; and(b) in any other manner the Board thinks fit.(2 of 2015 s. 62) 39. Keeping and transfer of records (19 of 2020 s. 13)(1) Subject to paragraph (2), all— (19 of 2020 s. 13)(a) poisons books;(b) books kept under section 28(3);(c) certificates given under section 22(1)(a) kept by authorized sellers of poisons;(d) books or other form of records and documents required to be kept or retained by licensed wholesale dealers or licensed manufacturers under regulation 28; and (2 of 2015 s. 63)(e) records and documents required to be kept or retained by licensed manufacturers under regulation 35, (2 of 2015 s. 63; 19 of 2020 s. 13)shall be preserved by the authorized seller of poisons, licensed wholesale dealer or licensed manufacturer, as the case may be, in the premises in which the transaction recorded took place— (2 of 2015 s. 63)(i) for a period of 2 years from the date of the last entry therein; or(ii) in relation to a certificate or document, for a period of 2 years from the date of the transaction.(2) For an advanced therapy product—(a) all books, records and documents required to be kept or retained in respect of the product under regulations 28 and 35(1)(a), (b), (c), (ca) and (h) (specified documents) must be preserved by the relevant licensed wholesale dealer or licensed manufacturer (specified person) for a period of 30 years after the expiry date of the product;(b) if, before the period referred to in subparagraph (a) expires—(i) for a specified person that is a natural person—the specified person becomes bankrupt or enters into a voluntary arrangement as defined by section 2 of the Bankruptcy Ordinance (Cap. 6) with the person’s creditors; or(ii) for a specified person that is a company as defined by section 2(1) of the Companies Ordinance (Cap. 622)—the specified person is commenced to be wound up or is dissolved without being wound up,the specified person must transfer the specified documents to the Board as soon as practicable after the event mentioned in sub-subparagraph (i) or (ii) occurs; and(c) if, before the period referred to in subparagraph (a) expires, the specified person ceases to operate as a licensed wholesale dealer or licensed manufacturer, the specified person must transfer the specified documents to the Board within 14 days after the cessation. (19 of 2020 s. 13) 40. Penalties Any person who contravenes any of the provisions of regulation 9(1) or (4), 10, 10A, 11, 12, 15, 16(1) or (2), 18, 19, 20, 21(1) or (2), 22(2), (3), (4) or (5), 23(1), (2) or (3), 24, 25, 27, 28, 29(1), 30(1), 31(1), 32, 33(1), (2), (3), (4), (4B), (4D) or (5), 34, 35, 36(1), 36A(6)(b), 38(1), 38A or 39 commits an offence and is liable on conviction to the penalties specified in section 34 of the Ordinance.(L.N. 262 of 1995; L.N. 366 of 1995; 2 of 2015 s. 64, 19 of 2020 s. 14) 41. Certificates, forms and fees (1) The certificate referred to in section 22(1)(a) may be given by any person known both to the intending purchaser and the intending seller and shall be in the specified form. (2 of 2015 s. 65)(2) (Repealed 2 of 2015 s. 65)(2A) The logo referred to in section 13A(1) shall be in the form prescribed in Schedule 8. (See Schedule 8, Form 17) (L.N. 85 of 1987; E.R. 5 of 2020)(3) (Repealed 2 of 2015 s. 65)(4) The fees to be paid under the Ordinance and these regulations shall be those prescribed in Schedule 9. (E.R. 5 of 2020)(E.R. 3 of 2015) 42. (Omitted as spent—E.R. 3 of 2015) Schedule 1 [regs. 3, 5, 6, 7, 17, 22& 24 & Sch. 5](2 of 2015 s. 66; E.R. 3 of 2015)Substances to which Certain Restrictions with respect to the Sale, Supply, Labelling and Storage Apply under Regulations 3, 5, 6, 22 and 24 (L.N. 41 of 2007; 2 of 2015 s. 66) Division A(L.N. 41 of 2007) Abacavir; its saltsAbataceptAbciximabAbemaciclib; its saltsAbiraterone; its saltsAbrocitinib; its saltsAcalabrutinib; its saltsAcamprosate; its saltsAcarbose; its saltsAcebutolol; its saltsAceclofenac; its saltsAcemetacin; its saltsAcetanilide; alkyl acetanilidesAcetazolamide; its saltsAcetohexamideAcetorphine; its salts; its esters and ethers; their saltsAcetylcarbromalAcetyldihydrocodeine; its saltsAciclovir; its salts; except when contained in skin creams packed in a package size of not more than 3 grams and labelled for the treatment of cold sores onlyAcipimox; its saltsAcitretin; its salts; its estersAclidinium; its saltsAdagrasib; its saltsAdalimumabAdapalene; its salts; its estersAdefovir; its salts; its esters; their saltsAfatinib; its saltsAfliberceptAfoxolaner; its saltsAgalsidase alfaAgalsidase betaAgomelatine; its saltsAlclofenac; its complexesAlcuronium; its saltsAldesleukinAlectinib; its saltsAlefaceptAlemtuzumabAlendronic acid; its saltsAlfacalcidol; its saltsAlfuzosin; its saltsAlglucosidase alfaAlirocumabAliskiren; its salts; its esters; their saltsAlizapride; its saltsAlkaloids, the following; their quaternary compounds; any salts, simple or complex, of any substance falling within the following—Calabar bean, alkaloids ofCoca, alkaloids of, except substances containing less than 0.1% of the alkaloids of cocaCocaine, except substances containing less than 0.1% of cocaineCodeineColchicum, alkaloids of; their saltsConiine, except substances containing less than 0.1% of coniineCotarnine, except substances containing less than 0.2% of cotarnineCurare, alkaloids of; curare basesEcgonine; its esters and ethers; except substances containing less than the equivalent of 0.1% of ecgonineEmetine, except substances containing less than 1% of emetineEphedrine; its optical isomers; their salts; when contained in aerosol dispensersErgot, alkaloids ofGalantamineGelsemium, alkaloids of, except substances containing less than 0.1% of the alkaloids of gelsemiumMorphine; its esters and ethers; except substances containing less than 0.2% of morphine calculated as anhydrous morphineNicotine (except when contained in (a) chewing gum or lozenges, intended to be used in nicotine replacement therapy and containing not more than 4 mg of Nicotine per piece; or (b) patches for external application, intended to be used in nicotine replacement therapy); any compound containing the chemical structure of 3-(1-methylpyrrolidin-2-yl)pyridine substituted to any degree or without substitutionPilocarpus, alkaloids of, except substances containing less than 0.5% of the alkaloids of pilocarpusRauwolfia, alkaloids of; their derivativesSabadilla, alkaloids of, except substances containing less than 1% of the alkaloids of sabadillaThebaine, except substances containing less than 1% of thebaineVeratrum, alkaloids of, except substances containing less than 1% of the alkaloids of veratrumVinca, alkaloids ofAllergen extract of Dermatophagoides farinaeAllergen extract of Dermatophagoides pteronyssinusAllopurinolAllylisopropylacetylureaAllylprodine; its saltsAlmitrine; its saltsAlogliptin; its saltsAlpelisib; its saltsAlphadolone; its estersAlphaxaloneAlprenolol; its saltsAlteplaseAlufibrateAmantadine; its saltsAmbrisentan; its salts; its esters; their saltsAmidopyrine; its saltsAmifostine; its saltsAmiloride; its saltsAmineptine; its saltsAminoglutethimide5-Aminolevulinic acid; its salts; its derivatives; their saltsAminopterin; its derivativesAminorex; its saltspara-Aminosalicylic acid; its salts; its derivatives; their salts; any compound with any substance falling within this itemAmiodarone; its saltsAmisulpride; its saltsAmitriptyline; its saltsAmivantamabAmlodipine; its saltsAmrinoneAmsacrine; its saltsAmylene hydrateAnagrelide; its saltsAnastrozole; its saltsAndexanet alfaAndrogenic, oestrogenic and progestational substances, the following—BenzoestrolDerivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their estersSteroid compounds with androgenic or oestrogenic or progestational activity; their esters;

except when contained in a preparation intended to be taken orally for contraceptive purposes only and each dose of the preparation contains not more than the following—0.15 mg of Desogestrel;3.00 mg of Drospirenone;0.05 mg of Ethinyloestradiol;0.10 mg of Gestodene;0.25 mg of Levonorgestrel;2.50 mg of Lynoestrenol;0.05 mg of Mestranol;1.00 mg of Norethisterone;0.25 mg of Norgestimate; and0.50 mg of NorgestrelAnidulafungin; its salts; its esters; their saltsAnifrolumabAnileridine; its saltsAnistreplaseAntihistamine substances, the following; their salts; any compound with any substance falling within this item—AntazolineAstemizoleBilastineDoxylamineMebhydrolinTerfenadineTripelennamineAntilymphocyte ImmunoglobulinsAntimonial poisons, except substances containing less than the equivalent of 1% of antimony trioxideAntisera, antitoxins, immunoglobulins and vaccines—(a) the following—Bacillus Calmette-Guérin (BCG)Digoxin-specific antibody fragmentsMeningococcal vaccinesNormal immunoglobulinsPneumococcal vaccinesRotavirus vaccinesSnake venom antiseraStaphylococcal vaccinesStreptococcal vaccines;(b) directed against the following diseases, viruses or organisms—Bordetella speciesBotulismCanine infectious diseaseCholeraDengue feverDiphtheriaFeline calicivirusFeline Chlamydia psittaciFeline immunodeficiency virusFeline leukemia virusFeline panleukopenia virusFeline rhinotracheitis virusHaemophilus influenzae type bHepatitis AHepatitis BHerpes simplexHerpes zosterHuman papillomavirusInfluenzaJapanese encephalitisMeaslesMumpsPertussisPlaguePoliomyelitisRabiesRespiratory syncytial virusRubellaSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)TetanusTyphoidVaricellaYellow feverAntithymocyte ImmunoglobulinApalutamide; its saltsApixaban; its saltsApomorphine; its salts; its quaternary compounds; except substances containing less than 0.2% of apomorphineApremilast; its saltsAprepitant; its saltsAprindine; its saltsAripiprazoleArsenic trioxide when contained in pharmaceutical productsArsenical poisons, except substances containing less than the equivalent of 0.01% of arsenic trioxide and except dentifrices containing less than 0.5% of acetarsol Artemether; its saltsArticaine; its saltsAsciminib; its saltsAsenapine; its salts; its isomersAsfotase alfaAsunaprevir; its saltsAtazanavir; its saltsAtenolol; its saltsAtezolizumabAtogepantAtomoxetine; its saltsAtorvastatin; its saltsAtosiban; its saltsAtovaquoneAtracurium besylateAtrasentan; its salts; its esters; their saltsAtropine; its salts; when contained in pharmaceutical products for human parenteral administration or pharmaceutical products intended to be used for slowing the progression of myopiaAuranofinAvacopan; its saltsAvalglucosidase alfaAvanafil; its saltsAvapritinib; its saltsAvatrombopag; its salts; its esters; their saltsAvelumabAxicabtagene ciloleucelAxitinib; its salts Azacitidine; its saltsAzacyclonal; its saltsAzapropazoneAzauridine; its derivativesAzilsartan; its salts; its esters; their saltsAziridine; its derivativesBaclofenBaloxavir; its salts; its esters and ethers; their saltsBambuterol and its salts when contained in aerosol dispensersBarbituric acid; its salts; its derivatives; their salts; any compound with any substance falling within this itemBaricitinib; its saltsBasiliximab; its saltsBecaplermin; its saltsBedaquiline; its saltsBefunolol; its saltsBelantamab mafodotinBelimumabBelumosudil; its saltsBelzutifan; its saltsBemiparin; its saltsBempedoic acid; its salts; its esters; their saltsBenactyzine; its saltsBenazepril; its saltsBenmelstobartBenoxaprofen; its saltsBenralizumabBenserazide; its saltsBenzbromaroneBenzethidine; its saltsBenzhexol; its saltsBenzoylmorphine; its saltsBenzquinamideBenztropine and its homologues; their saltsBenzylmorphine; its saltsBesifloxacin; its salts; its esters; their saltsBetahistine; its salts; except when contained in pharmaceutical products containing betahistine hydrochloride or betahistine mesilate (a) labelled with a maximum recommended daily dose of the pharmaceutical product having the equivalent of 48 mg of betahistine hydrochloride or 36 mg of betahistine mesilate; (b) stated for use only in patients of 18 years old or above for relief of vertigo symptoms only; and (c) to be sold in packs for a maximum of 5 days’ useBetaxolol; its saltsBethanidine; its saltsBevacizumabBexarotene; its saltsBezafibrateBezitramide; its saltsBicalutamide; its saltsBictegravir; its saltsBimekizumabBinimetinib; its saltsBiphenylacetic acid; its salts; its esters; except when contained in preparations intended for external use onlyN-[4,4-Bis(para-fluorophenyl)butyl]piperidine, 4-substituted derivatives of; their saltsBisoprolol; its saltsBitolterol and its salts when contained in aerosol dispensersBivalirudin; its saltsBlinatumomabBlood products derived from human blood or manufactured by biotechnology, the following—AlbuminAntithrombinsBlood clotting factorsFibrinFibrinogenPlasma protein fractionsThrombinBoceprevir; its saltsBortezomibBosentan; its saltsBotulinum toxin complexesBrentuximab vedotinBretylium tosylateBrexpiprazole; its saltsBrigatinib; its saltsBrimonidine; its saltsBrinzolamide; its saltsBrivaracetam; its saltsBrodalumabBrolucizumabBromocriptine; its saltsBromvaletoneBroncho-VaxomBrotizolamBucolomeBufexamacBuformin; its saltsBumadizone; its saltsBumetanide; its salts; its derivatives; their saltsBupivacaine; its saltsBupranolol; its saltsBuprenorphine; its saltsBupropion; its saltsBurosumabBuserelin; its saltsBuspirone; its saltsBusulphan; its saltsButorphanol; its saltsCabazitaxel; its salts; its esters; their saltsCabergoline; its saltsCabotegravir; its saltsCabozantinib; its saltsCalcifediolCalcipotriol; its saltsCalcitriol; its saltsCanagliflozin; its saltsCanakinumabCandesartan; its salts; its esters; their saltsCannabidiol; its salts; when contained in pharmaceutical productsCannabinol and its tetrahydro or hexahydro derivatives; their 3-alkyl homologues; any ester or ether of any substance falling within this itemCannabis; the resin of cannabis; extracts of cannabis; tinctures of cannabis; cannabin tennateCapecitabine; its saltsCapivasertib; its saltsCapmatinib; its saltsCaptodiamine; its saltsCaptoprilCarbacholCarbamazepineCarbidopa; its saltsCarbimazole; its saltsCarboplatinCarbromalCarbutamideCarfilzomib; its saltsCarglumic acid; its salts; its esters; their saltsCariprazine; its saltsCarisoprodolCarmustineCarperidine; its saltsCarprofen; its saltsCarteolol; its saltsCarvedilol; its saltsCasirivimabCaspofungin; its saltsCatequentinib (Anlotinib); its saltsCedazuridine; its saltsCelecoxib; its saltsCeliprolol; its saltsCemiplimabCenobamate; its saltsCeritinib; its saltsCerivastatin; its saltsCertolizumab pegolCetrorelix; its salts; its esters; their saltsCetuximabChlofenamic acid; its saltsChloral; its addition and its condensation products other than alphachloralose; any compound with any substance falling within this item, except when contained, in the form of chloral hydrate, in preparations intended for external application onlyChlordiazepoxide; its saltsChlormethiazole; its saltsChlormezanoneChloroform, except substances containing not more than 5% of chloroform or when in preparations not intended for the internal treatment of human ailmentsChloroquine; its saltsChlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonamide 1,1-dioxide, whether hydrogenated or not; their saltsChlorphenoxamine; its saltsChlorphentermine; its saltsChlorpropamide; its saltsChlorprothixene and other derivatives of 9-methylenethiaxanthen; their saltsChlorthalidone and other derivatives of ortho-chlorobenzene-sulphonamideChlorzoxazoneChorionic GonadotrophinChymopapainCicletanine; its saltsCidofovir; its saltsCilazapril; its saltsCilgavimabCilostazol; its saltsCinacalcet; its saltsCinepazide; its saltsCiprofibrate; its saltsCiprofloxacin; its salts; its estersCisaprideCisatracurium besylateCisplatinCitalopram; its saltsCiticoline; its salts; when contained in pharmaceutical products intended to be used for the treatment of cognitive and neurological disorders associated with cerebrovascular disease or brain injury, or bothCladribineClioquinolClobazamClodronic acid; its salts; its estersClofarabine; its salts; its esters; their saltsClofazimine; its saltsClofibrateClomiphene; its saltsClomipramine; its salts; its derivatives; their saltsClonidine; its saltsClonitazene; its saltsClopidogrel; its saltsClorexoloneCloridarolClorprenaline and its salts when contained in aerosol dispensersClothiapineClozapine; its saltsCobicistat; its saltsCobimetinib; its saltsCodergocrine mesilateColaspaseColfosceril; its saltsCollagen, purifiedContrast media, the following; their salts; any compound with any substance falling within this item; when contained in preparations for parenteral use—Acetrizoic acidDiatrizoic acidFerucarbotranGadobenic acidGadobutrolGadodiamideGadopentetic acidGadoteric acidIobitridolIocarmic acidIocetamic acidIodamideIodipamideIodised oilIodixanolIodoxamic acidIoglicic acidIoglycamic acidIohexolIomeprolIopamidolIopanoic acidIophendylateIopromideIothalamic acidIotrolanIotroxic acidIoversolIoxaglic acidIoxitalamic acidIpodic acidMetrizamidePropyliodoneSulphur hexafluorideTyropanoic acidCorifollitropin alfaCorticorelin; its saltsCorticotrophinsCorynebacterium parvumCrisaborole; its saltsCrizotinib; its salts 4-Cyano-2-dimethylamino-4,4-diphenylbutane; its salts4-Cyano-1-methyl-4-phenylpiperidine; its saltsCyclarbamateCyclobenzaprine; its saltsCyclofenilCyclosporin ACytarabine; its saltsDabigatran etexilate; its saltsDabrafenib; its saltsDacarbazineDaclatasvir; its saltsDaclizumabDacomitinib; its saltsDalteparin; its saltsDanicopan; its saltsDapagliflozin; its salts Dapoxetine; its saltsDapsoneDaratumumabDarbepoetin alfaDaridorexant; its saltsDarifenacin; its saltsDarolutamide; its saltsDarunavir; its saltsDasabuvir; its saltsDasatinib; its saltsDatopotamab deruxtecanDeanol acetamidobenzoateDebrisoquine; its saltsDecitabine; its saltsDeferasirox; its salts; its esters; their saltsDeferiprone; its saltsDefibrotideDegarelix; its saltsDehydroemetine; its saltsDelafloxacin; its salts; its esters; their saltsDelamanid; its saltsDelandistrogene moxeparvovecDemecarium bromideDenosumabDesferrioxamine; its saltsDesfluraneDesipramine; its saltsDesomorphine; its salts; its esters and ethers; their saltsDesvenlafaxine; its saltsDeucravacitinib; its saltsDexketoprofen; its saltsDexlansoprazole; its saltsDexmedetomidine; its saltsDexrazoxane; its saltsDiacerein; its salts; its estersDiampromide; its saltsDiazepam and other compounds containing the chemical structure of dihydro-1, 4-benzodiazepine substituted to any degree; their saltsDiazoxideDiclofenac; its salts; except when contained in preparations for external application onlyDidanosine; its saltsDigitalis, glycosides of; other active principles of digitalisDihydralazine; its saltsDihydrocodeine; its salts; its esters and ethers; their saltsDihydrocodeinone; its saltsDihydrocodeinone O-carboxymethyloxime; its salts; its esters; their saltsDihydrocodeinone enol acetate; its saltsDihydroergotamine; its salts, simple or complexDihydroetorphine; its saltsDihydromorphine; its salts; its esters and ethers; their salts3-(3,4-Dihydroxyphenyl)alanine; its saltsDiltiazem; its saltsDimefline; its saltsDimenoxadole; its saltsDimepheptanol; its salts; its esters and ethers; their saltsDimethyl fumarate when contained in pharmaceutical productsDinutuximab betaDioxaphetyl butyrate; its saltsDipipanone; its saltsDiprenorphine; its saltsDipyridamoleDiquafosol; its saltsDisopyramide; its saltsDistigmine; its saltsDisulfiramDithienylallylamines; dithienylalkylallylamines; their saltsDobutamine; its saltsDocetaxel; its saltsDolutegravir; its saltsDomperidone; its saltsDonanemabDonepezil; its saltsDopamine; its saltsDoravirine; its saltsDornase alfaDorzagliatin; its saltsDorzolamide; its saltsDostarlimabDothiepin; its saltsDoxapram; its saltsDoxazosin; its saltsDoxepin; its salts; its derivatives; their saltsDronedarone; its saltsDroperidolDrotrecogin alfaDulaglutideDuloxetine; its saltsDupilumabDurvalumabDutasterideDyflosEcothiopate iodideEctylureaEculizumabEdoxaban; its saltsEfalizumabEfanesoctocog alfaEfavirenz; its saltsEfinaconazole; its saltsElacestrant; its saltsEladocagene exuparvovecElapegademaseElbasvir; its saltsEletriptan; its saltsElosulfase alfaElotuzumabElranatamabEltrombopag; its salts; its esters; their saltsElvitegravir; its saltsEmbutramideEmicizumabEmpagliflozin; its saltsEmtricitabine; its saltsEmylcamateEnalapril; its saltsEnalaprilat; its saltsEncorafenib; its saltsEnfortumab vedotinEnfuvirtideEnoxacin; its salts; its estersEnoxaparin; its saltsEnoximoneEnrofloxacin; its salts; its estersEnsifentrine; its saltsEntacapone; its saltsEntecavir; its salts; its esters; their saltsEntrectinib; its saltsEnzalutamide; its saltsEpcoritamabEplerenoneEpoetin betaEprosartan; its saltsEptifibatide; its saltsEptinezumabEquecabtagene autoleucelErdafitinib; its saltsErenumabEribulin; its saltsErlotinib; its saltsErtugliflozin; its saltsEsmolol; its saltsEsomeprazole; its saltsEtafenone; its saltsEtamivan; its saltsEtanerceptEtelcalcetide; its saltsEthacrynic acid; its saltsEthambutol; its saltsEthchlorvynolEthinamateEthionamideEthoglucidEthoheptazine; its saltsEthosuximide; its saltsEthylmorphine; its salts; its esters and ethers; their salts; except substances containing less than 0.2% of ethylmorphineEtidronic acid; its salts; when contained in pharmaceutical productsEtilefrine; its saltsEtodolacEtofibrateEtomidate; its saltsEtonitazene; its saltsEtoposide; its estersEtoricoxib; its saltsEtorphine; its salts; its esters and ethers; their saltsEtoxeridine; its saltsEtranacogene dezaparvovecEtrasimod; its salts; its esters; their saltsEtravirineEtretinateEtryptamine; its saltsEverolimus; its salts; its esters; their saltsEvocalcet; its salts; its esters; their saltsEvolocumabExemestane; its saltsExenatideEzetimibeFamciclovir; its saltsFampridine; its salts FaricimabFebuxostat; its salts; its esters; their saltsFelodipineFenbufenFencamfamin; its saltsFenclofenac; its saltsFendiline; its saltsFenfluramine; its saltsFenofibrateFenoprofen; its saltsFenoterol and its salts when contained in aerosol dispensersFenoxazoline; its saltsFentanyl; its saltsFentiazac; its saltsFenticonazole; its saltsFeprazoneFesoterodine; its salts; its esters; their saltsFezolinetant; its saltsFilgotinib; its saltsFilgrastimFinasterideFinerenone; its saltsFingolimod; its salts; its esters; their saltsFirocoxib; its saltsFitusiran; its saltsFlavoxate; its saltsFlecainide; its saltsFleroxacin; its salts; its estersFluanisoneFluconazole; its saltsFludarabine; its saltsFlufenamic acid; its salts; its esters; their saltsFlumazenilFlumethrin; its saltsFluorouracil; its derivativesFluoxetine; its saltsFlupenthixol; its saltsFluralaner; its saltsFlurbiprofenFluspirileneFlutamideFluvastatinFluvoxamine; its saltsFolinic acid; its saltsFondaparinux; its saltsFormestaneFormoterol and its salts when contained in aerosol dispensersFosaprepitant; its saltsFoscarnet trisodium hexahydrateFosinopril; its saltsFosnetupitant; its saltsFosphenytoin; its saltsFostamatinib; its saltsFotemustine; its saltsFremanezumabFruquintinib; its saltsFrusemideFulvestrantFulzerasib; its saltsFurethidine; its saltsFutibatinib; its saltsGabapentin; its saltsGadoxetic acid; its saltsGalcanezumabGallamine; its salts; its quaternary compoundsGallium-68; its salts; when contained in pharmaceutical productsGallopamil; its saltsGalsulfaseGanciclovir; its saltsGanirelix; its saltsGaradacimabGatifloxacin; its salts; its estersGefitinib; its saltsGemcitabine; its saltsGemfibrozilGemtuzumab ozogamicinGermanium-68; its salts; when contained in pharmaceutical productsGilteritinib; its saltsGimeracil; its saltsGlecaprevir; its saltsGlibenclamideGlibornurideGliclazideGlimepiride; its saltsGlipizideGliquidoneGlofitamabGlucagon; its saltsGlucarpidaseGlutathione; its salts; its derivatives; when contained in products for human parenteral administrationGlutethimide; its saltsGlycerol phenylbutyrateGlycopyrronium; its saltsGlymidineGolimumabGonadorelin; its saltsGoserelin; its saltsGozetotide; its saltsGranisetron; its saltsGrazoprevir; its saltsGrepafloxacin; its salts; its estersGuanabenz; its saltsGuanethidine; its saltsGuanfacine; its saltsGuanidines, the following—Polymethylene diguanidines; di-para-anisyl-para-phenethylguanidine; their saltsGuselkumabHalofantrine; its saltsHaloperidol and other 4-substituted derivatives of N-(3-para-fluorobenzoylpropyl) piperidineHemin; its salts; its esters; their saltsHexachlorophane contained in medicinal products except (a) in the case of medicinal products for human use substances containing 0.1% or less; and (b) in the case of medicinal products for animal use (i) aerosols the contents of the container of which contain 0.1% or less; (ii) soaps and shampoos containing 2% or less; (iii) other medicinal products containing 0.75% or less; and (c) preparations for oral administration to sheep or cattle for liver fluke diseaseHexamethylmelamineHexapropymateHexobendine; its saltsHuman chondrocytes when contained in advanced therapy products indicated for the repair of symptomatic articular cartilage defectsHuman cytomegalovirus immunoglobulinHydralazine; its saltsHydrazines, the following and their alpha-methyl derivatives—Benzyl hydrazinePhenethyl hydrazinePhenoxyethyl hydrazinetheir salts; their acyl derivatives; their saltsHydrocyanic acid, except substances containing less than 0.15%, weight in weight, of hydrocyanic acid (HCN); cyanides, other than ferrocyanides and ferricyanides, except substances containing less than the equivalent of 0.1% weight in weight, of hydrocyanic acid (HCN)Hydromorphinol; its salts; its esters and ethers; their saltsHydromorphone; its salts; its esters and ethers; their saltsHydroxychloroquine; its saltsHydroxy-N,N-dimethyltryptamines; their esters and ethers; any salt of any substance falling within this item3-Hydroxy-N-methylmorphinan; its salts; its optical isomers; their salts3-Hydroxymorphinan; its salts; its optical isomers; their salts; their esters and ethers; their salts3-Hydroxy-N-phenacylmorphinan; its salts; its optical isomers; their salts; their esters and ethers; their saltsHydroxypethidine; its salts; its esters and ethers; their saltsHydroxyphenamateHydroxyureaHydroxyzine; its saltsIbandronic acid; its saltsIbritumomab tiuxetanIbrutinib; its saltsIcatibant; its salts; its esters; their saltsIcosapent ethyl when contained in pharmaceutical products indicated for the reduction of the risk of myocardial infarction, stroke, coronary revascularization, or unstable angina requiring hospitalizationIdarucizumabIdelalisib; its saltsIdursulfaseIdursulfase betaIfosfamideIloprost; its saltsImatinib; its saltsImdevimabImidapril; its saltsImigluceraseImipramine; its saltsImiquimod; its saltsInaticabtagene autoleucelInavolisib; its saltsInclisiran; its saltsIndacaterol; its salts; its esters; their saltsIndinavir; its saltsIndomethacin; its saltsIndoprofen; its saltsIndoramin; its saltsInfliximabInosineInosine pranobexInotuzumab ozogamicinInterferonsIodine-131; its salts; when contained in pharmaceutical productsIoflupane Iodine-123; its salts; when contained in pharmaceutical productsIpilimumabIprindole; its saltsIptacopan; its saltsIrbesartan; its saltsIrinotecan; its saltsIsatuximabIsavuconazole; its salts; its derivatives; their saltsIsoaminile; its saltsIsoetharine; its saltsIsofluraneIsomethadone; its saltsIsoniazid; its salts; its derivatives; their salts; any compound with any substance falling within this itemIsoprenaline; its saltsIsopyrin; its saltsIsotretinoinIsoxicam; its saltsIsradipineItraconazole; its saltsIvabradine; its saltsIvosidenib; its saltsIxazomib; its saltsIxekizumabKetamine; its saltsKetanserin; its saltsKetobemidone; its salts; its esters and ethers; their saltsKetoconazole, except when contained in preparations for external application onlyKetophenylbutazoneKetorolac; its salts; its estersLabetalol; its saltsLabuvirtideLacidipine; its saltsLacosamide; its saltsLamivudine; its saltsLamotrigine; its saltsLanadelumabLanreotide; its saltsLansoprazoleLanthanum carbonateLapatinib; its saltsLaronidaseLaropiprant; its saltsLarotrectinib; its saltsLatanoprostene bunod; its saltsLazertinib; its saltsLead, compounds of, with acids from fixed oilsLebrikizumabLecanemabLedipasvir; its saltsLeflunomide; its saltsLemborexant; its saltsLenacapavir; its saltsLenalidomide; its saltsLenvatinib; its saltsLepirudin; its saltsLercanidipine; its saltsLetermovir; its salts; its esters; their saltsLetrozoleLeuprorelin; its saltsLevallorphan; its saltsLevetiracetam; its saltsLevosimendan; its saltsLidoflazineLignocaine; its salts; when in mixture with prilocaine or in mixture with the salts of prilocaine, and intended to be used for the treatment of premature ejaculationLignocaine; its salts; when in mixture with tetracaine (being an amino alcohol esterified with a derivative of benzoic acid) or in mixture with the salts of tetracaineLinaclotide; its saltsLinagliptin; its saltsLinezolid; its saltsLipegfilgrastimLiraglutideLisdexamfetamine; its saltsLisinopril; its saltsLithium carbonateLithium sulphateLixisenatideLomefloxacin; its salts; its estersLomustineLonazolac; its saltsLoncastuximab tesirineLopinavir; its saltsLoracarbef; its saltsLorcainide; its saltsLorlatinib; its saltsLosartan; its saltsLotilaner; its saltsLovastatin when contained in pharmaceutical productsLoxapine; its saltsLumefantrine; its saltsLurasidone; its saltsLurbinectedin; its saltsLuspaterceptLutetium-177; its salts; when contained in pharmaceutical productsLutetium (177Lu) oxodotreotide; its saltsLutetium (177Lu) vipivotide tetraxetan; its saltsLysuride; its saltsMacitentan; its saltsMangafodipir; its saltsMannomustine; its saltsMaprotiline; its saltsMaralixibat; its saltsMaraviroc; its saltsMarbofloxacin; its saltsMaribavir; its saltsMarstacimabMavacamten; its saltsMazdutideMazindolMebutamateMecamylamine; its saltsMeclofenamic acid; its saltsMeclofenoxate; its saltsMedigoxinMefenamic acid; its salts; its esters; their saltsMefloquine; its saltsMefrusideMelagatran; its salts; its derivatives; their saltsMelatonin; its salts; when contained in pharmaceutical products intended to be used for the treatment of insomniaMelitracen; its saltsMeloxicam; its saltsMemantine; its saltsMephenesin; its esters; their saltsMephenoxaloneMepirizole; its saltsMepivacaine; its saltsMepolizumabMeprobamatealpha-Meprodine; its saltsbeta-Meprodine; its saltsMercaptopurine; its salts; its derivatives; their saltsMercuric chloride, except substances containing less than 1% of mercuric chloride; mercuric iodide, except substances containing less than 2% of mercuric iodide; nitrates of mercury, except substances containing less than the equivalent of 3%, weight in weight, of mercury (Hg); potassiomercuric iodides, except substances containing less than the equivalent of 1% of mercuric iodide; organic compounds of mercury, except substances, not being aerosols, containing less than the equivalent of 0.3%, weight in weight, of mercury (Hg)Meropenem; its saltsMertiatide; its salts; its esters; their saltsMesalazine; its saltsMescaline; its salts; other derivatives of phenethylamine formed by substitution in the aromatic ring; their saltsMesocarb; its saltsMetaflumizone; its saltsMetaraminol; its saltsMetaxaloneMetazocine; its salts; its esters and ethers; their saltsMetergolineMetformin; its saltsMethadone; its saltsMethadyl acetate; its saltsMethaqualone; its saltsMethimazole; its saltsMethixene; its saltsMethocarbamolMethorphan; its salts; its optical isomers; their salts; except substances containing not more than 0.1% of dextromethorphanMethoxsalenMethoxyfluraneMethyldesorphine; its salts; its esters and ethers; their saltsMethyldihydromorphine; its salts; its esters and ethers; their saltsMethyldopa; its esters; their salts2-Methyl-3-morpholino-1,1-diphenylpropane carboxylic acid; its salts; its esters; their saltsMethylnaltrexone; its saltsMethylpentynol; its derivativesalpha-Methylphenethylamine; beta-methylphenethylamine; alpha-ethylphenethylamine; beta-ethylphenethylamine; their optical isomers; any synthetic compound structurally derived from any of those substances by substitution in the aliphatic part or by ring closure therein (or by both such substitution and such closure) or by substitution in the aromatic ring (with or without substitution at the nitrogen atom), except hydroxyamphetamine, methoxyphenamine, pholedrine and N-substituted derivatives of ephedrine; any salt of any substance falling within this itemMethylphenidate; its salts1-Methyl-4-phenylpiperidine-4-carboxylic acid; its salts; its esters; their saltsMethypryloneMetipranolol; its saltsMetoclopramide; its saltsMetolazoneMetopon; its salts; its esters and ethers; their saltsMetoprolol; its saltsMetronidazole; its salts; its esters; their saltsMetyrapone; its saltsMexiletine; its saltsMianserin; its saltsMibefradil; its saltsMicafungin; its salts; its estersMidodrine; its saltsMidostaurin; its saltsMifepristone; its salts; its esters; their saltsMigalastat; its saltsMiglitol; its saltsMilnacipran; its saltsMilrinone; its saltsMinoxidil, except when contained in preparations intended for external application only and the preparations contain not more than 5% of MinoxidilMirabegron; its salts; its esters; their saltsMirogabalin; its salts; its esters; their saltsMirtazapine; its saltsMitobronitolMitopodozide; its saltsMitotaneMitoxantrone; its saltsMivacurium; its saltsMizolastine; its saltsMobocertinib; its saltsMoclobemide; its saltsMoexipril; its saltsMofebutazone; its saltsMolgramostimMolindone; its saltsMolnupiravir; its saltsMolybdate (99Mo); its salts; when contained in pharmaceutical productsMomelotinib; its saltsMontelukast; its saltsMoracizine; its saltsMoramide; its salts; its optical isomers; their saltsMoroxydine; its saltsMorpheridine; its saltsMosunetuzumabMoxifloxacin; its saltsMoxonidine; its saltsMuromonab-CD3Mustine and any other N-substituted derivative of di-(2-chloroethyl)amine; their saltsMuzolimineMycophenolic acid; its salts; its estersMyrophine; its saltsNabumetoneNadolol; its saltsNadroparin; its saltsNafarelin; its saltsNaftidrofuryl; its saltsNalbuphine; its saltsNaldemedine; its saltsNalidixic acidNalmefene; its saltsNalorphine; its saltsNaloxone; its saltsNaltrexone; its saltsalpha-Naphthylacetic acid; its saltsNaproxen; its saltsNaratriptan; its saltsNatalizumabNateglinide; its salts; its estersNaxitamabNebivolol; its saltsNecitumumabNefazodone; its saltsNefopam; its saltsNelfinavir; its saltsNeostigmine; its saltsNepafenac; its saltsNeratinib; its saltsNesiritideNetarsudil; its saltsNetupitant; its saltsNevirapine; its saltsNicardipine; its saltsNicergolineNicocodine; its saltsNicotinamide mononucleotide when contained as an active ingredient in products for human parenteral administrationNicotinic acid and its salts when contained in pharmaceutical products the recommended daily dose of which contains more than 200 mg of nicotinic acidNifedipineNifenazoneNiflumic acid; its saltsNifuratel; its saltsNifuroxazide; its saltsNilotinib; its saltsNilvadipineNimesulide; its saltsNimodipineNintedanib; its saltsNiraparib; its saltsNirmatrelvir; its saltsNirsevimabNisoldipineNitrendipineNitric oxide when contained in pharmaceutical productsNitrofural; its saltsNitrofurantoin; its saltsNitromethaqualone; its saltsNitrous oxide when contained in pharmaceutical productsNitroxoline; its saltsNivolumabNomifensine; its saltsNoracymethadol; its saltsNoramidopyrine methanesulphonate; its saltsNorcodeine; its salts; its esters and ethers; their saltsNorfloxacin; its salts; its estersNormethadone; its saltsNormorphine; its salts; its esters and ethers; their saltsNorpipanone; its saltsNortriptyline; its saltsNusinersen; its saltsObinutuzumab; its antibody drug conjugatesOclacitinib; its saltsOcrelizumabOcriplasminOctreotide; its saltsOdevixibat; its salts; its esters; their saltsOfatumumabOfloxacin; its salts; its estersOlanzapine; its saltsOlaparib; its saltsOlaratumabOlmesartan; its salts; its esters; their saltsOlodaterol; its saltsOlsalazine; its saltsOmalizumabOmbitasvir; its saltsOmega-3 fatty acids; their salts; their esters; when contained in pharmaceutical products intended to be used for the treatment of hypertriglyceridaemiaOmidenepag; its salts; its esters; their saltsOnasemnogene abeparvovecOndansetron; its saltsOpipramol; its salts; its derivatives; their saltsOpium, except substances containing less than 0.2% of morphine calculated as anhydrous morphineOrciprenaline; its saltsOrgoteinOrlistat; its salts; except when contained in a pharmaceutical product of which the recommended dose is a quantity of the product that contains not more than 60 mg of orlistat or its salts, taken 3 times a dayOrphenadrine; its saltsOseltamivir; its saltsOsimertinib; its saltsOteracil; its saltsOuabainOxaliplatin; its saltsOxanamideOxcarbazepine; its saltsOxprenolol; its saltsOxycodone; its salts; its esters and ethers; their saltsOxyfedrine; its saltsOxymorphone; its salts; its esters and ethers; their saltsOxypertineOxyphenbutazoneOxytocinsOzanimod; its saltsPaclitaxelPalbociclib; its saltsPaliperidone; its saltsPalivizumabPalonosetron; its saltsPamidronate; its saltsPancuronium; its saltsPanitumumabPanobinostat; its saltsPantethine; its saltsPantoprazole; its salts; except when contained in oral preparations with 20 mg or less per solid dosage unit, indicated with the maximum daily dose of 20 mg for relief of heartburn symptoms associated with acid reflux in patients of 18 years old or above, and in packs with the maximum supply of 7 daysParaldehydeParamethadioneParecoxib; its saltsPargyline; its saltsParicalcitol; its salts; its esters; their saltsParitaprevir; its saltsParoxetine; its saltsPasireotide; its saltsPazopanib; its saltsPefloxacin; its salts; its estersPegaptanib; its saltsPegaspargasePegfilgrastimPegunigalsidase alfaPegvisomant; its saltsPembrolizumabPemetrexed; its salts; its esters; their saltsPemigatinib; its saltsPemirolast; its saltsPemoline; its saltsPempidine; its saltsPenbutolol; its saltsPenciclovir; its saltsPenicillamine; its saltsPentamidine; its saltsPentazocine; its saltsPentolinium; its saltsPentoxifylline; its saltsPerampanelPerflubutanePergolide; its saltsPerindoprilat; its salts; its esters; their saltsPertechnetate (99mTc); its salts; when contained in pharmaceutical productsPertuzumabPharmaceutical products for human parenteral administration containing the following or their salts, as active ingredients, except in mixture with insulin—Acetic acidAcetylcholineAcetylcysteineAdenosineAdrenalineAmbroxolAmino acidsAminophyllineAnti-D (rho) immunoglobulinsAntihistamine substancesBetiatideBicisateButetamateCaffeineCarnitineCations, the following, except in preparations containing any substance to which the Antibiotics Ordinance (Cap. 137) applies—CalciumChromiumCopperIronMagnesiumManganesePotassiumSeleniumSodium, except sodium chloride 0.9%ZincCholineCimetidineCiticolineDeoxycholic acidDextromethorphanDicycloverineDifenidolDiprophyllineDisofeninEphedrineExametazimeFish oilFluoresceinGalliumGelatinGlucosamineGlucoseGlycerolGlyceryl trinitrateGuaifenesinHeparinHyaluronic acidHyaluronidaseHydroxyethyl starchHyoscineIbuprofenIcodextrinIndigo carmineIndocyanine greenIodine norcholesterolIsosorbideLactic acidLecithinLignocaineMannitolMebrofeninMedronic acidMesnaMethoxyphenamineMethylene blueMethylephedrineNoradrenalineOlive oilOmeprazoleOxidronatePapaverineParacetamolPatent blue VPentetic acidPhenolPhenylephrineProcaineProtamineRanitidineRheniumSodium chloride 0.9%Sodium pyrophosphateSodium tetradecyl sulfateSodium thiosulfateSorbitolSoya oilStonefish antivenomSuccimerTerbutalineTetrakis copper tetrafluoroborateTetrofosminThalliumTinTriglyceridesTuberculinVitaminsWaterXantinol nicotinatePhenacemidePhenacetinPhenadoxone; its saltsPhenaglycodolPhenampromide; its saltsPhenazocine; its salts; its esters and ethers; their saltsPhenbutrazatePhencyclidine; its saltsPhenetidylphenacetinPhenformin; its saltsPhenindionePhenomorphan; its salts; its esters and ethers; their saltsPhenoperidine; its salts; its esters and ethers; their saltsPhenothiazine; its salts; its derivatives (except dimethoxanate and promethazine); their salts (except salts of dimethoxanate and promethazine); any compound with any substance falling within this itemPhenoxybenzamine; its saltsPhenprenazonePhenprobamatePhentolamine; its saltsPhenylbutazone; its salts2-Phenylcinchoninic acid; 2-salicylcinchoninic acid; their salts; their esters5-Phenylhydantoin; its alkyl and aryl derivatives; their salts4-Phenylpiperidine-4-carboxylic acid ethyl ester; its saltsPholcodine; its salts; its esters and ethers; their salts; except substances containing less than 1.5% of pholcodinePhospholipid fraction; when contained in pharmaceutical products intended to be used as pulmonary surfactant for the treatment of respiratory distress syndromePibrentasvir; its saltsPicrotoxinPimecrolimusPiminodine; its saltsPimobendan; its saltsPioglitazone; its saltsPipecuronium; its saltsPipemidic acidPipobromanPiracetam; its saltsPirfenidone; its saltsPiritramide; its saltsPiromidic acid; its saltsPiroxicam, except when contained in preparations for external application onlyPirprofen; its saltsPirtobrutinib; its saltsPitavastatin; its salts; its esters; their saltsPitolisant; its saltsPituitary gland, the active principles of, other than corticotrophins, oxytocins and vasopressinsPizotifen; its saltsPlerixafor; its saltsPolatuzumab vedotinPolymethylenebistrimethylammonium saltsPomalidomide; its saltsPonatinib; its saltsPonesimod; its saltsPoractant alfaPorfimer; its saltsPosaconazole; its salts; its esters; their saltsPralidoxime; its saltsPralsetinib; its saltsPramipexole; its saltsPrasterone; its salts; when contained in pharmaceutical productsPrasugrel; its saltsPravastatin; its salts; its estersPrazosin; its saltsPregabalin; its saltsPretomanid; its saltsPridinol; its saltsPrimaquine; its saltsPrimidonePrindolol; its saltsProbenecidProbucolProcainamide; its saltsProcarbazine; its saltsProcaterol and its salts when contained in aerosol dispensersProcyclidine; its saltsalpha-Prodine; its saltsbeta-Prodine; its saltsProglumetacin; its saltsProguanil; its saltsProheptazine; its saltsPromoxolanePropafenone; its saltsPropanididPropiverine; its saltsPropofolPropoxur; its saltsPropoxyphene; its salts; its optical isomers; their saltsPropranolol; its salts; its derivatives; their saltsPropylhexedrine; its saltsPropylthiouracil; its saltsProquazoneProstaglandins, the following and their derivatives—AlprostadilBimatoprostDinoprostDinoprostoneEpoprostenolLatanoprostMisoprostolTravoprostUnoprostonetheir salts; their estersProthionamideProthipendyl; its saltsProtirelin; its saltsProtriptyline; its salts; its derivatives; their saltsPrucalopride; its saltsPrulifloxacin; its salts; its esters; their saltsPyrazinamidePyricarbate (Pyridinolcarbamate)Pyridostigmine; its saltsPyrimethaminePyriprole; its saltsPyrithyldioneQuetiapine; its saltsQuinagolide; its saltsQuinapril; its saltsQuinethazoneQuinidine; its saltsQuinine; its salts; its derivatives; their saltsQuizartinib; its saltsRabeprazole; its saltsRacecadotril; its saltsRactopamine; its saltsRadium-223; its salts; when contained in pharmaceutical productsRaloxifene; its saltsRaltegravir; its saltsRaltitrexed; its saltsRamipril; its saltsRamucirumabRanibizumabRanolazine; its salts Rasagiline; its saltsRasburicase; its saltsRavulizumabReboxetine; its saltsRecombinant human erythropoietinRegadenoson; its saltsRegorafenib; its salts Remdesivir; its saltsRemifentanil; its saltsRemoxipride; its saltsRepaglinide; its salts; its estersRepotrectinib; its saltsReproterol and its salts when contained in aerosol dispensersRescinnamineReteplaseRetigabine; its saltsRevefenacin; its saltsReviparin; its saltsRibavirin; its saltsRibociclib; its saltsRilmenidine; its saltsRilpivirine; its saltsRiluzole; its saltsRimegepant; its saltsRimiterol and its salts when contained in aerosol dispensersRimonabant; its saltsRiociguat; its saltsRipretinib; its saltsRisankizumabRisdiplam; its saltsRisedronic acid; its saltsRisperidoneRitlecitinib; its saltsRitodrine; its saltsRitonavir; its saltsRituximabRivaroxaban; its saltsRivastigmine; its saltsRizatriptan; its saltsRocuronium; its saltsRofecoxib; its saltsRoflumilast; its saltsRomiplostimRomosozumabRopeginterferon alfa-2bRopinirole; its saltsRopivacaine; its saltsRosiglitazone; its saltsRosoxacin; its saltsRosuvastatin; its saltsRotigotine; its saltsRoxadustat; its saltsRozanolixizumabRufinamide; its saltsRurioctocog alfa pegolRuxolitinib; its salts Sacituzumab govitecanSacubitril; its saltsSafinamide; its saltsSalbutamol and its salts, except when contained in aerosol dispensersSalmeterol and its salts when contained in aerosol dispensersSaquinavir; its saltsSarilumabSatralizumabSavolitinib; its saltsSaxagliptin; its saltsSebelipase alfaSecukinumabSelexipag; its saltsSelinexor; its saltsSelpercatinib; its saltsSelumetinib; its saltsSemaglutideSermorelin; its saltsSerplulimabSertindole; its saltsSertraline; its saltsSevelamer; its saltsSevofluraneSibutramine; its salts; any compound containing the chemical structure of 1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan-1-amine substituted to any degree or without substitution; its saltsSildenafil; its salts; any compound containing the chemical structure of 5-(2-ethoxyphenyl)-1-methyl-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-7(6H)-one substituted to any degree or without substitution; its saltsSilodosin; its saltsSiltuximabSimeprevir; its saltsSimvastatinSintilimabSiponimod; its salts; its esters; their saltsSirolimus; its saltsSitagliptin; its saltsSocazolimabSodium aurothiomalateSodium nitroprussideSodium zirconium cyclosilicateSofosbuvir; its saltsSolifenacin; its salts; its esters; their saltsSolriamfetol; its saltsSomapacitanSomatostatinSomatrogonSorafenib; its saltsSotalol; its saltsSotaterceptSotorasib; its saltsSparfloxacin; its salts; its estersSparteine; its saltsSpesolimabSpinosadSpironolactoneStavudine; its saltsStiripentol; its saltsStreptokinaseStrontium ranelateStrophanthus, glycosides ofStyramateSucroferric oxyhydroxideSugammadex; its salts; its esters; their saltsSulindacSulphinpyrazoneSulphonal; alkyl sulphonalsSulpirideSultoprideSumatriptan; its saltsSunitinib; its saltsSuprarenal gland, the active principles of, except adrenaline and noradrenaline (other than when contained in aerosol dispensers); their salts; except salts of adrenaline (other than when contained in aerosol dispensers); their derivatives; their salts; except hydrocortisone and its salts when contained in preparations intended for external application only at not more than 1%; except beclomethasone and its salts when contained in aerosol dispensers and except clobetasone butyrate when contained in preparations intended for external application only at not more than 0.05%Surufatinib; its saltsSutoprofen; its saltsSuxamethonium; its saltsSyrosingopineTacrine; its saltsTacrolimusTadalafil; its salts; any compound containing the chemical structure of 6-(Benzo[1,3]dioxol-5-yl)-2,3,6,7,12,12a-hexahydropyrazino[1’,2’:1,6]pyrido[3,4-b]indole-1,4-dione substituted to any degree or without substitution; its saltsTafamidis; its saltsTafasitamabTafluprostTafolecimabTagraxofuspTalazoparib; its saltsTaletrectinib; its saltsTalquetamabTamoxifen; its saltsTapentadol; its salts TarlatamabTazarotene; its saltsTazemetostat; its saltsTeclistamabTegaserod; its saltsTelbivudine; its saltsTelmisartan; its saltsTemozolomide; its saltsTemsirolimus; its salts; its estersTenapanor; its saltsTenecteplase; its saltsTeniposideTenofovir; its salts; its derivatives; their saltsTenoxicamTepotinib; its saltsTeprotumumabTerazosin; its saltsTerbinafine; its salts; except when contained in preparations for external application onlyTerbutaline and its salts when contained in aerosol dispensersTeriflunomide; its saltsTeriparatide; its saltsTerodiline; its saltsTertatolol; its saltsTetrabenazine; its saltsTetracosactide; its saltsTezepelumabThalidomide; its saltsThallium, salts ofTheofibrateThiacetazoneThiocarlide; its saltsThioctic acid; its salts; its derivatives; when contained in pharmaceutical productsThiotepaThymosin alpha 1Thyroid gland, the active principles of; their saltsThyrotropin alfaTiagabine; its salts; its esters; their saltsTianeptine; its salts; its esters; their saltsTiapride; its saltsTicagrelor; its salts; its esters; their saltsTiclopidine; its saltsTildrakizumabTiletamine; its saltsTilidate; its saltsTiludronic acid; its saltsTimolol; its saltsTinoridine; its saltsTinzaparin; its saltsTiotropium; its saltsTipiracil; its salts; when contained in pharmaceutical productsTiratricol; its saltsTirofiban; its saltsTirzepatideTisagenlecleucelTislelizumabTisotumab vedotinTixagevimabTizanidine; its saltsTocainide; its saltsTocilizumabTodralazine; its saltsTofacitinib; its salts Tofenacin; its saltsTolazamideTolbutamideTolcapone; its saltsTolfenamic acid; its saltsTolmetin; its saltsTolperisone; its saltsTolterodine; its saltsTolvaptanpara-Tolylmethylcarbinol nicotinic acid esterTopiramate; its saltsTopotecan; its saltsTorasemideToripalimabTrabectedin; its salts; its estersTramadol; its saltsTrametinib; its saltsTrandolapril; its saltsTranexamic acid, except when contained in toothpaste at 0.05% by weightTranylcypromine; its saltsTrastuzumab; its antibody drug conjugatesTrazodone; its saltsTremelimumabTreosulfan; its saltsTreprostinil; its salts; its esters; their saltsTretamine; its saltsTretinoinTriamterene; its saltsTriaziquoneTribromoethyl alcohol2,2,2-Trichloroethyl alcohol, esters of; their saltsTrientine; its salts; when contained in pharmaceutical productsTrifarotene; its salts; its esters; their saltsTrifluridine; its saltsTrilostaneTrimeperidine; its saltsTrimetaphan; its saltsTrimetazidine; its saltsTrimethadioneTrimethoprimTrimetozineTrimetrexate; its saltsTrimipramine; its saltsTrioxsalenTriptorelin; its saltsTromantadine; its salts; except when contained in pharmaceutical products labelled for the treatment of cold sores onlyTropisetron; its saltsTrospium chlorideTrovafloxacin; its salts; its derivatives; their saltsTucatinib; its saltsTulobuterol and its salts when contained in aerosol dispensersTybamateUmeclidinium; its saltsUpadacitinib; its saltsUrapidil; its saltsUrethaneUrokinaseUstekinumabValaciclovir; its saltsValdecoxib; its saltsValganciclovir; its saltsValnoctamideValproic acid; its salts; its estersValsartan; its saltsVandetanib; its saltsVardenafil; its salts; any compound containing the chemical structure of 2-(2-ethoxyphenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one substituted to any degree or without substitution; its saltsVarenicline; its saltsVasopressinsVecuronium; its saltsVedolizumabVelmanase alfaVelpatasvir; its saltsVemurafenib; its saltsVenetoclax; its saltsVenlafaxine; its saltsVeralipride; its saltsVerapamil; its saltsVericiguat; its saltsVernakalant; its saltsVerteporfin; its saltsVidarabine; its saltsVigabatrinVilanterol; its saltsVildagliptin; its saltsViloxazine; its saltsVindesine; its saltsVinorelbine; its saltsVismodegib; its saltsVitamin A and its esters when contained in pharmaceutical products the recommended daily dose of which contains not less than 10,000 international units of vitamin AVitamin D and its salts when contained in pharmaceutical products the recommended daily dose of which contains more than 1,000 international units of vitamin DVitamin K and its salts when contained in pharmaceutical products, except products with recommended daily dose of 120 mcg or less of vitamin K1 or K2 or its saltsVonoprazan; its saltsVorasidenib; its saltsVoriconazole; its saltsVortioxetine; its salts VosoritideVoxilaprevir; its saltsVutrisiran; its saltsWarfarin; its saltsXamoterol; its saltsXylazine; its saltsZafirlukastZalcitabine; its saltsZaleplon; its saltsZanamivir; its saltsZanubrutinib; its saltsZidovudineZimelidine; its saltsZipeprol; its saltsZiprasidone; its saltsZofenopril; its saltsZolazepam; its saltsZolbetuximabZoledronic acid; its saltsZolmitriptan; its saltsZolpidem; its saltsZomepirac; its saltsZongertinib; its saltsZopicloneZoxazolamine; its salts(L.N. 137 of 1978; L.N. 369 of 1980; L.N. 415 of 1984; L.N. 129 of 1986; L.N. 130 of 1987; L.N. 197 of 1989; L.N. 128 of 1990; L.N. 384 of 1992; L.N. 262 of 1995; L.N. 130 of 1998; L.N. 22 of 1999; L.N. 202 of 1999; L.N. 30 of 2000; L.N. 138 of 2000; L.N. 235 of 2000; L.N. 296 of 2000; L.N. 51 of 2001; L.N. 143 of 2001; L.N. 173 of 2001; L.N. 287 of 2001; L.N. 56 of 2002; L.N. 112 of 2002; L.N. 132 of 2002; L.N. 170 of 2002; L.N. 237 of 2002; L.N. 73 of 2003; L.N. 179 of 2003; L.N. 181 of 2003; L.N. 273 of 2003; L.N. 276 of 2003; L.N. 74 of 2004; L.N. 135 of 2004; L.N. 191 of 2004; L.N. 11 of 2005; L.N. 72 of 2005; L.N. 114 of 2005; L.N. 212 of 2005; L.N. 25 of 2006; L.N. 122 of 2006; L.N. 178 of 2006; L.N. 223 of 2006; L.N. 277 of 2006; L.N. 41 of 2007; L.N. 98 of 2007; L.N. 143 of 2007; L.N. 208 of 2007; L.N. 239 of 2007; L.N. 61 of 2008; L.N. 113 of 2008; L.N. 197 of 2008; L.N. 234 of 2008; L.N. 282 of 2008; L.N. 90 of 2009; L.N. 147 of 2009; L.N. 199 of 2009; L.N. 258 of 2009; L.N. 11 of 2010; L.N. 32 of 2010; L.N. 81 of 2010; L.N. 104 of 2010; L.N. 140 of 2010; L.N. 23 of 2011; L.N. 127 of 2011; L.N. 33 of 2012; L.N. 124 of 2012; L.N. 179 of 2012; L.N. 19 of 2013; L.N. 94 of 2013; L.N. 98 of 2013; L.N. 125 of 2013; L.N. 158 of 2013; L.N. 195 of 2013; L.N. 39 of 2014; L.N. 134 of 2014; 2 of 2015 s. 66; L.N. 34 of 2015; L.N. 67 of 2015; L.N. 100 of 2015; L.N. 193 of 2015; L.N. 235 of 2015; L.N. 40 of 2016; L.N. 51 of 2016; L.N. 83 of 2016; L.N. 119 of 2016; L.N. 172 of 2016; L.N. 11 of 2017; L.N. 38 of 2017; L.N. 119 of 2017; L.N. 140 of 2017; L.N. 167 of 2017; L.N. 10 of 2018; L.N. 42 of 2018; L.N. 80 of 2018; L.N. 136 of 2018; L.N. 191 of 2018; L.N. 210 of 2018; L.N. 228 of 2018; L.N. 3 of 2019; L.N. 10 of 2019; L.N. 30 of 2019; L.N. 145 of 2019; L.N. 184 of 2019; L.N. 14 of 2020; L.N. 41 of 2020; L.N. 126 of 2020; E.R. 5 of 2020; L.N. 212 of 2020; L.N. 252 of 2020; L.N. 104 of 2021; L.N. 218 of 2021; L.N. 1 of 2022; L.N. 19 of 2022; L.N. 33 of 2022; L.N. 122 of 2022; L.N. 194 of 2022; L.N. 232 of 2022; L.N. 10 of 2023; L.N. 108 of 2023; L.N. 138 of 2023; L.N. 9 of 2024; L.N. 73 of 2024; L.N. 105 of 2024; L.N. 135 of 2024; L.N. 177 of 2024; L.N. 5 of 2025; L.N. 38 of 2025; L.N. 116 of 2025; L.N. 161 of 2025; L.N. 211 of 2025; L.N. 13 of 2026; L.N. 42 of 2026) Division B(L.N. 41 of 2007) Barium, salts of, except barium sulphate Dinitronaphthols; dinitrophenols; dinitrothymols meta-Nitrophenol; ortho-nitrophenol; para-nitrophenol Phosmet (L.N. 195 of 1977; L.N. 137 of 1978; L.N. 129 of 1986; L.N. 262 of 1995) Schedule 2 [reg. 8]Articles Exempted by Regulation 8 from the Provisions of the Ordinance and of these Regulations Group I General Exemptions Adhesives; anti-fouling compositions; builders’ materials; ceramics; distempers; electrical valves; enamels; explosives; fillers; fireworks; fluorescent lamps; glazes; glues; inks; lacquer solvents; loading materials; matches; motor fuels and lubricants; paints other than pharmaceutical paints; photographic paper; pigments; plastics; propellants; rubber; varnishes(L.N. 195 of 1977; L.N. 262 of 1995) Group II Special Exemptions Division A (L.N. 41 of 2007) Poison Substance or article in which exempted Alkaloids, the following— Brucine Surgical spirit containing not more than 0.015% of brucine Emetine Ipecacuanha; extracts and tinctures of ipecacuanha;

substances containing less than 0.05% of emetine Lobelia, alkaloids of Preparations for the relief of asthma in the form of cigarettes, smoking mixtures or fumigants; substances containing less than 0.1% of the alkaloids of lobelia Pilocarpus, alkaloids of Substances containing less than 0.025% of the alkaloids of pilocarpus, preparations containing not more than 2%, weight of the sulphate salt of transpilosine (L.N. 137 of 1978) Pomegranate,alkaloids of Pomegranate bark Stavesacre, alkaloids of Soaps; ointments; lotions for external use para-Aminobenzene-sulphonamide; its salts; derivatives of para-aminobenzene-sulphonamide having any of the hydrogen atoms of the para amino group or of the sulphonamide group substituted by another radical; their salts Feeding stuffs containing not more than 0.5% of total sulphonamides Androgenic, oestrogenic and progestational substances, the following— Benzoestrol Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their esters Preparations intended for external application only; except preparations containing more than 4 milligrams of oestrogenic substance per 100 grams of inert substance and preparations containing testosterone or its esters (L.N. 90 of 2009; E.R. 5 of 2020) Steroid compoundswith androgenic or oestrogenic or progestationalactivity; their esters Multivitamin preparations (with or without minerals) containing not more than the following in each dosage form— 0.01 mg of Ethinyloestradiol; and 2.50 mg of Methyltestosterone (L.N. 105 of 2024) Antihistamine substances; their salts; any compound with any substance falling within this item Preparations intended for external application only and preparations containing not more than 1% of antihistamine substances for application in the nose or eye (E.R. 5 of 2020) Arsenical poisons Poultry or pig feeding stuffs containing not more than 0.005% of 4-hydroxy-3-nitrophenylarsonic acid and not containing any other arsenical poison; animal feeding stuffs containing not more than 0.01% of arsenilic acid and not containing any other arsenical poison; poultry feeding stuffs containing not more than 0.0375% of carbarsone and not containing any other arsenical poison; medicines containing arsenic in a non-assimilable form Barbituric acid; its salts; its derivatives; their salts; any compound with anysubstance falling withinthis item Self-heating preparations, in aerosol dispensers intended for external application only, containing 1, 5-diethyl-2-thio-4, 6-pyrimidine-dione and not containing any other substance mentioned opposite hereto in the first column Chloroform Substances containing less than 1% of chloroform; solid preparations; toothpaste Clioquinol Preparations intended for external application only (L.N. 137 of 1978) Creosote obtained fromwood Substances containing less than 50% of creosote obtained from wood Diperodon; its salts Preparations intended for external application only, containing not more than 1% of diperodon, calculated as anhydrous base Hydrocyanic acid Preparations of wild cherry; in reagent kits supplied for medical or veterinary purposes; substances containing less than the equivalent of 0.1%, weight in weight, of hydrocyanic acid (HCN) Lead acetate Substances containing less than 4% of lead acetate Lead, compounds of Machine-spread plasters Lignocaine; its salts Preparations intended for external application only, containing not more than 0.7% of Lignocaine or its salts (L.N. 369 of 1980) Mercury, nitrates of Ointments containing less than the equivalent of 3%, weight in weight, of mercury (Hg) Mescaline; its salts Living plants Phenols Butylated hydroxytoluene, carvacrol, creosote obtained from coal tar; essential oils in which phenols occur naturally; medicines containing less than 1% of phenols; nasal sprays, mouth washes, pastilles, lozenges, capsules, pessaries, ointments or suppositories containing less than 2.5% of phenols, in reagent kits supplied for medical or veterinary purposes; smelling bottles; soaps for washing; solid substances, other than pastilles, lozenges, capsules, pessaries, ointments and suppositories, containing less than 60% of phenols; Tar (coal or wood), crude or refined; para-tertiary amylphenol; tertiary butylcresol; para-tertiary butylphenol; para-(1, 1, 3, 3-tetramethylbutyl) phenol; thymol Phenyl mercuric salts Toilet, cosmetic and therapeutic preparations containing not more than 0.01% of phenyl mercuric salts as preservative; antiseptic dressings on toothbrushes; in textiles containing not more than 0.01% of phenyl mercuric salts as a bacteriostat and fungicide Picric acid Substances containing less than 5% of picric acid Podophyllum resin Preparations containing not more than 1.5%, weight in weight, of podophyllum resin Procaine Feeding stuffs containing any substance to which the Antibiotics Ordinance (Cap. 137) for the time being applies Quinine; its salts; itsderivatives; their salts Preparations containing not more than 1% of quinine, its salts, its derivatives or their salts; soft drinks, wines or tonic wines; preparations containing not more than 15% of quinine, its salts, its derivatives or their salts for use in the manufacture of soft drinks, wines, tonic wines, or confectionery (L.N. 130 of 1987) Sodium ethyl mercurithio-salicylate Therapeutic substances containing less than 0.1% of sodium ethyl mercurithiosalicylate as a preservative Sodium fluoride Substances containing less than 3% of sodium fluoride as a preservative; dentifrices containing not more than 0.33% of sodium fluoride; mouth wash tablets containing not more than 0.2% of sodium fluoride and liquid mouth washes containing not more than 0.05% thereof; tablets containing not more than 0.016%, weight in weight, of sodium fluoride and intended, when chewed to prevent tooth decay (L.N. 202 of 1999; E.R. 1 of 2015) Tranexamic acid Topical preparations containing not more than 3% of tranexamic acid as cosmetic products not intended for the treatment of human ailments (L.N. 19 of 2022) (L.N. 138 of 2000) Division B(L.N. 41 of 2007) Poison Substance or article in which exempted Acetanilide; alkylacetanilides Substances not being preparations for the treatment of human ailments Ammonia Substances not being solutions of ammonia or preparations containing solutions of ammonia; substances containing less than 5%, weight in weight, of ammonia (NH3); refrigerators; smelling bottles Antimony, chlorides of Polishes Arsenical poisons Pyrites ores or sulphuric acid containing arsenical poisons as natural impurities Barium, salts of Witherite other than finely ground witherite; barium carbonate bonded to charcoal for case hardening; fire extinguishers containing barium chloride gamma-Benzenehexachloride Substances containing not more than 5% by weight of gamma-benzene hexachloride; when used in agriculture or horticulture (L.N. 195 of 1977) Diamines, the following; their salts—phenylene diamines; toluene diamines; other alkylated-benzene diamines Substances other than preparations for the dyeing of hair Dinitrophenols Substances not being preparations for the treatment of human ailments Disulfiram Substances not being preparations for the treatment of human ailments Formaldehyde Substances containing less than 5%, weight in weight, of formaldehyde (H. CHO); photographic glazing or hardening solutions Formic acid Substances containing less than 5%, weight in weight, of formic acid(H. COOH) Hydrochloric acid Substances containing less than 9%, weight in weight, of hydrochloric acid (HCl) Mercuric chloride Batteries Mercuric chloride; mercuric iodide; organic compounds of mercury Dressings on seeds or bulbs Mercury, oxides of Canker and wound paints (for trees) containing not more than 3%, weight in weight, of yellow mercuric oxide Nicotine Tobacco in any conventional smoking product (as defined by section 2(1) of the Smoking (Public Health) Ordinance (Cap. 371)) (L.N. 177 of 2024) Nitric acid Substances containing less than 9%, weight in weight, of nitric acid (HNO2) Nitrobenzene Substances containing less than 0.1% of nitrobenzene; soaps containing less than 1% of nitrobenzene; polishes para-Nitrobenzyl cyanide Photographic solutions containing less than the equivalent of 0.1%, weight in weight, of hydrocyanic acid (HCN) para-Nitrophenol Preparations for use in agriculture or horticulture containing not more than 0.5% of para-Nitrophenol as preservative Oxalic acid; metallicoxalates Laundry blue; polishes; cleaning powders or scouring products containing the equivalent of not more than 10% of oxalic acid dihydrate Phosphoric acid Substances containing phosphoric acid, not being descaling preparations containing more than 50%, weight in weight, of ortho-phosphoric acid (L.N. 137 of 1978) Potassium hydroxide Substances containing the equivalent of less than 17% of total caustic alkalinity expressed as potassium hydroxide; accumulators, batteries Sodium hydroxide Substances containing the equivalent of less than 12% of total caustic alkalinity expressed as sodium hydroxide Sodium nitrite Substances other than preparations containing more than 0.1% of sodium nitrite for the destruction of rats or mice Sodium silicofluoride Substances containing less than 3% of sodium silicofluoride as preservative Sulphaquinoxaline; its salts Preparations for the destruction of mice and rats containing not more than the equivalent of 0.5% of sulphaquinoxaline Sulphuric acid Substances containing less than 9%, weight in weight, of sulphuric acid (H2SO4); accumulators; batteries and sealed containers in which sulphuric acid is packed together with car batteries for use in those batteries; fire extinguishers (L.N. 195 of 1977; L.N. 262 of 1995) Schedule 3 [regs. 3 & 9 & Schs. 5 & 10](2 of 2015 s. 67; E.R. 3 of 2015)Substances Required by Regulation 9 to be Sold by Retail only upon a Prescription Given by a Registered Medical Practitioner, Registered Dentist or Registered Veterinary Surgeon (L.N. 614 of 1997) Division A(L.N. 39 of 2014) Abacavir; its saltsAbataceptAbciximabAbemaciclib; its saltsAbiraterone; its saltsAbrocitinib; its saltsAcalabrutinib; its saltsAcamprosate; its saltsAcarbose; its saltsAcebutolol; its saltsAceclofenac; its saltsAcemetacin; its saltsAcetanilide; alkyl acetanilidesAcetazolamide; its saltsAcetohexamideAcetorphine; its salts; its esters and ethers; their saltsAcetylcarbromalAcetyldihydrocodeine; its saltsAciclovir; its salts; except when contained in skin creams packed in a package size of not more than 3 grams and labelled for the treatment of cold sores onlyAcipimox; its saltsAcitretin; its salts; its estersAclidinium; its saltsAdagrasib; its saltsAdalimumabAdapalene; its salts; its estersAdefovir; its salts; its esters; their saltsAfatinib; its saltsAfliberceptAfoxolaner; its saltsAgalsidase alfaAgalsidase betaAgomelatine; its saltsAlclofenac; its complexesAlcuronium; its saltsAldesleukinAlectinib; its saltsAlefaceptAlemtuzumabAlendronic acid; its saltsAlfacalcidol; its saltsAlfuzosin; its saltsAlglucosidase alfaAlirocumabAliskiren; its salts; its esters; their saltsAlizapride; its saltsAlkaloids, the following; their quaternary compounds; any salt, simple or complex, of any substance falling within the following—Calabar bean, alkaloids ofCodeine, except substances containing less than 0.2% of codeineColchicum, alkaloids of; their saltsConiine, except substances containing less than 0.1% of coniineCotarnine, except substances containing less than 0.2% of cotarnineCurare, alkaloids of; curare basesEmetine, except substances containing less than 1% of emetineEphedrine; its optical isomers; their salts; when contained in aerosol dispensersErgot, alkaloids ofGalantamineGelsemium, alkaloids of, except substances containing less than 0.1% of the alkaloids of gelsemiumPilocarpus, alkaloids of, except substances containing less than 0.5% of the alkaloids of pilocarpusRauwolfia, alkaloids of; their salts; derivatives of the alkaloids of rauwolfia; their saltsSabadilla, alkaloids of, except substances containing less than 1% of the alkaloids of sabadillaVeratrum, alkaloids of, except substances containing less than 1% of the alkaloids of veratrumVinca, alkaloids ofAllergen extract of Dermatophagoides farinaeAllergen extract of Dermatophagoides pteronyssinusAllopurinolAllylisopropylacetylureaAlmitrine; its saltsAlogliptin; its saltsAlpelisib; its saltsAlphadolone; its estersAlphaxaloneAlprenolol; its saltsAlteplaseAlufibrateAmantadine; its saltsAmbrisentan; its salts; its esters; their salts Amidopyrine; its saltsAmifostine; its saltsAmiloride; its saltsAmineptine; its saltspara-Aminobenzenesulphonamide; its salts; derivatives of para-aminobenzenesulphonamide having any of the hydrogen atoms of the para-amino group or of the sulphonamide group substituted by another radical; their salts; except when contained in preparations intended for external application or surgical dressings or in preparations for the prevention and treatment of diseases in poultryAminoglutethimide5-Aminolevulinic acid; its salts; its derivatives; their saltsAminopterin; its derivativesAminorex; its saltspara-Aminosalicylic acid; its salts; its derivatives; their salts; any compound with any substance falling within this itemAmiodarone; its saltsAmisulpride; its saltsAmitriptyline; its saltsAmivantamabAmlodipine; its saltsAmrinoneAmsacrine; its saltsAmylene hydrateAnagrelide; its saltsAnastrozole; its saltsAndexanet alfaAndrogenic, oestrogenic and progestational substances, the following—BenzoestrolDerivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their estersSteroid compounds with androgenic or oestrogenic or progestational activity; their esters; except when contained in a preparation intended to be taken orally for contraceptive purposes only and each dose of the preparation contains not more than the following—0.15 mg of Desogestrel;3.00 mg of Drospirenone;0.05 mg of Ethinyloestradiol;0.10 mg of Gestodene;0.25 mg of Levonorgestrel;2.50 mg of Lynoestrenol;0.05 mg of Mestranol;1.00 mg of Norethisterone;0.25 mg of Norgestimate; and0.50 mg of NorgestrelAnidulafungin; its salts; its esters; their saltsAnifrolumabAnistreplaseAntihistamine substances, the following; their salts; any compound with any substance falling within this item—AntazolineAstemizoleBilastineDoxylamineMebhydrolinTerfenadineTripelennamineAntilymphocyte ImmunoglobulinsAntisera, antitoxins, immunoglobulins and vaccines—(a) the following—Bacillus Calmette-Guérin (BCG)Digoxin-specific antibody fragmentsMeningococcal vaccinesNormal immunoglobulinsPneumococcal vaccinesRotavirus vaccinesSnake venom antiseraStaphylococcal vaccinesStreptococcal vaccines;(b) directed against the following diseases, viruses or organisms—Bordetella speciesBotulismCanine infectious diseaseCholeraDengue feverDiphtheriaFeline calicivirusFeline Chlamydia psittaciFeline immunodeficiency virusFeline leukemia virusFeline panleukopenia virusFeline rhinotracheitis virusHaemophilus influenzae type bHepatitis AHepatitis BHerpes simplexHerpes zosterHuman papillomavirusInfluenzaJapanese encephalitisMeaslesMumpsPertussisPlaguePoliomyelitisRabiesRespiratory syncytial virusRubellaSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)TetanusTyphoidVaricellaYellow feverAntithymocyte ImmunoglobulinApalutamide; its saltsApixaban; its saltsApomorphine; its salts; its quaternary compounds; except substances containing less than 0.2% of apomorphineApremilast; its saltsAprepitant; its saltsAprindine; its saltsAripiprazoleArsenic trioxide when contained in pharmaceutical productsArtemether; its saltsArticaine; its saltsAsciminib; its saltsAsenapine; its salts; its isomersAsfotase alfaAsunaprevir; its saltsAtazanavir; its saltsAtenolol; its saltsAtezolizumabAtogepantAtomoxetine; its saltsAtorvastatin; its saltsAtosiban; its saltsAtovaquoneAtracurium besylateAtrasentan; its salts; its esters; their saltsAtropine; its salts; when contained in pharmaceutical products for human parenteral administration or pharmaceutical products intended to be used for slowing the progression of myopiaAuranofinAvacopan; its saltsAvalglucosidase alfaAvanafil; its saltsAvapritinib; its saltsAvatrombopag; its salts; its esters; their saltsAvelumabAxicabtagene ciloleucelAxitinib; its salts Azacitidine; its saltsAzacyclonol; its saltsAzapropazoneAzauridine; its derivativesAzilsartan; its salts; its esters; their saltsAziridine; its derivativesBaclofenBaloxavir; its salts; its esters and ethers; their saltsBambuterol and its salts when contained in aerosol dispensersBarbituric acid; its salts; its derivatives; their salts; any compound with any substance falling within this itemBaricitinib; its saltsBasiliximab; its saltsBecaplermin; its saltsBedaquiline; its saltsBefunolol; its saltsBelantamab mafodotinBelimumabBelumosudil; its saltsBelzutifan; its saltsBemiparin; its saltsBempedoic acid; its salts; its esters; their saltsBenactyzine; its saltsBenazepril; its saltsBenmelstobartBenoxaprofen; its saltsBenralizumabBenserazide; its saltsBenzbromaroneBenzhexol; its saltsBenzquinamideBenztropine and its homologues; their saltsBesifloxacin; its salts; its esters; their saltsBetahistine; its salts; except when contained in pharmaceutical products containing betahistine hydrochloride or betahistine mesilate (a) labelled with a maximum recommended daily dose of the pharmaceutical product having the equivalent of 48 mg of betahistine hydrochloride or 36 mg of betahistine mesilate; (b) stated for use only in patients of 18 years old or above for relief of vertigo symptoms only; and (c) to be sold in packs for a maximum of 5 days’ useBetaxolol; its saltsBethanidine; its saltsBevacizumabBexarotene; its saltsBezafibrateBicalutamide; its saltsBictegravir; its saltsBimekizumabBinimetinib; its saltsBiphenylacetic acid; its salts; its esters; except when contained in preparations intended for external use onlyN-[4,4-Bis(para-fluorophenyl)butyl]piperidine,4-substituted derivatives of; their saltsBisoprolol; its saltsBitolterol and its salts when contained in aerosol dispensersBivalirudin; its saltsBlinatumomabBlood products derived from human blood or manufactured by biotechnology, the following—AlbuminAntithrombinsBlood clotting factorsFibrinFibrinogenPlasma protein fractionsThrombinBoceprevir; its saltsBortezomibBosentan; its saltsBotulinum toxin complexesBrentuximab vedotinBretylium tosylateBrexpiprazole; its saltsBrigatinib; its saltsBrimonidine; its saltsBrinzolamide; its saltsBrivaracetam; its saltsBrodalumabBrolucizumabBromocriptine; its saltsBromvaletoneBroncho-VaxomBrotizolamBucolomeBufexamacBuformin; its saltsBumadizone; its saltsBumetanide; its salts; its derivatives; their saltsBupivacaine; its saltsBupranolol; its saltsBuprenorphine; its saltsBupropion; its saltsBurosumabBuserelin; its saltsBuspirone; its saltsBusulphan; its saltsButorphanol; its saltsCabazitaxel; its salts; its esters; their saltsCabergoline; its saltsCabotegravir; its saltsCabozantinib; its saltsCalcifediolCalcipotriol; its saltsCalcitriol; its saltsCanagliflozin; its saltsCanakinumabCandesartan; its salts; its esters; their saltsCannabidiol; its salts; when contained in pharmaceutical productsCannabinol and its tetrahydro or hexahydro derivatives; their 3-alkyl homologues; any ester or ether of any substance falling within this itemCapecitabine; its saltsCapivasertib; its saltsCapmatinib; its saltsCaptodiamine; its saltsCaptoprilCaramiphen; its salts; except tablets containing not more than the equivalent of 7.5 milligrams of caramiphen base and liquid preparations containing not more than the equivalent of 0.1% of caramiphen baseCarbacholCarbamazepineCarbidopa; its saltsCarbimazole; its saltsCarboplatinCarbromalCarbutamideCarfilzomib; its saltsCarglumic acid; its salts; its esters; their saltsCariprazine; its saltsCarisoprodolCarmustineCarperidine; its saltsCarprofen; its saltsCarteolol; its saltsCarvedilol; its saltsCasirivimabCaspofungin; its saltsCatequentinib (Anlotinib); its saltsCedazuridine; its saltsCelecoxib; its saltsCeliprolol; its saltsCemiplimabCenobamate; its saltsCeritinib; its saltsCerivastatin; its saltsCertolizumab pegolCetrorelix; its salts; its esters; their saltsCetuximabChlofenamic acid; its saltsChloral; its addition and its condensation products other than alphachloralose; any compound with any substance falling within this item, except when contained, in the form of chloral hydrate, in preparations intended for external application onlyChlordiazepoxide; its saltsChlormethiazole; its saltsChlormezanoneChloroquine; its saltsChlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonamide 1, 1-dioxide, whether hydrogenated or not; their saltsChlorphenoxamine; its saltsChlorphentermine; its saltsChlorpropamide; its saltsChlorprothixene and other derivatives of 9-methylenethiaxanthen; their saltsChlorthalidone and other derivatives of ortho-chlorobenzene sulphonamideChlorzoxazoneChorionic GonadotrophinChymopapainCicletanine; its saltsCidofovir; its saltsCilazapril; its saltsCilgavimabCilostazol; its saltsCinacalcet; its saltsCinepazide; its saltsCiprofibrate; its saltsCiprofloxacin; its salts; its estersCisaprideCisatracurium besylateCisplatinCitalopram; its saltsCiticoline; its salts; when contained in pharmaceutical products intended to be used for the treatment of cognitive and neurological disorders associated with cerebrovascular disease or brain injury, or bothCladribineClioquinolClobazamClodronic acid; its salts; its estersClofarabine; its salts; its esters; their saltsClofazimine; its saltsClofibrateClomiphene; its saltsClomipramine; its salts; its derivatives; their saltsClonidine; its saltsClopidogrel; its saltsClorexoloneCloridarolClorprenaline and its salts when contained in aerosol dispensersClothiapineClozapine; its saltsCobicistat; its saltsCobimetinib; its saltsCodergocrine mesilateColaspaseColfosceril; its saltsCollagen, purifiedContrast media, the following; their salts; and compound with any substance falling within this item; when contained in preparations for parenteral use—Acetrizoic acidDiatrizoic acidFerucarbotranGadobenic acidGadobutrolGadodiamideGadopentetic acidGadoteric acidIobitridolIocarmic acidIocetamic acidIodamideIodipamideIodised oilIodixanolIodoxamic acidIoglicic acidIoglycamic acidIohexolIomeprolIopamidolIopanoic acidIophendylateIopromideIothalamic acidIotrolanIotroxic acidIoversolIoxaglic acidIoxitalamic acidIpodic acidMetrizamidePropyliodoneSulphur hexafluorideTyropanoic acidCorifollitropin alfaCorticorelin; its saltsCorticotrophinsCorynebacterium parvumCrisaborole; its saltsCrizotinib; its saltsCyclarbamateCyclobenzaprine; its saltsCyclofenilCyclosporin ACytarabine; its saltsDabigatran etexilate; its saltsDabrafenib; its saltsDacarbazineDaclatasvir; its saltsDaclizumabDacomitinib; its saltsDalteparin; its saltsDanicopan; its saltsDapagliflozin; its saltsDapoxetine; its saltsDapsoneDaratumumabDarbepoetin alfaDaridorexant; its saltsDarifenacin; its saltsDarolutamide; its saltsDarunavir; its saltsDasabuvir; its saltsDasatinib; its saltsDatopotamab deruxtecanDeanol acetamidobenzoateDebrisoquine; its saltsDecitabine; its saltsDeferasirox; its salts; its esters; their saltsDeferiprone; its saltsDefibrotideDegarelix; its saltsDehydroemetine; its saltsDelafloxacin; its salts; its esters; their saltsDelamanid; its saltsDelandistrogene moxeparvovecDemecarium bromideDenosumabDesferrioxamine; its saltsDesfluraneDesipramine; its saltsDesvenlafaxine; its saltsDeucravacitinib; its saltsDexketoprofen; its saltsDexlansoprazole; its saltsDexmedetomidine; its saltsDexrazoxane; its saltsDiacerein; its salts; its estersDiazepam and other compounds containing the chemical structure of dihydro-1,4-benzodiazepine substituted to any degree; their saltsDiazoxideDiclofenac; its salts; except when contained in preparations for external application onlyDidanosine; its saltsDigitalis, glycosides of; other active principles of digitalisDihydralazine; its saltsDihydroergotamine; its salts, simple or complexDihydroetorphine; its salts3-(3,4-Dihydroxyphenyl)alanine; its saltsDiltiazem; its saltsDimefline; its saltsDimethyl fumarate when contained in pharmaceutical productsDinutuximab betaDiprenorphine; its saltsDipyridamoleDiquafosol; its saltsDisopyramide; its saltsDistigmine; its saltsDisulfiramDithienylallylamines; dithienylalkylallylamines; their salts; except diethylthiambutene, dimethylthiambutene and ethylmethylthiambuteneDobutamine; its saltsDocetaxel; its saltsDolutegravir; its saltsDomperidone; its saltsDonanemabDonepezil; its saltsDopamine; its saltsDoravirine; its saltsDornase alfaDorzagliatin; its saltsDorzolamide; its saltsDostarlimabDothiepin; its saltsDoxapram; its saltsDoxazosin; its saltsDoxepin; its salts; its derivatives; their saltsDronedarone; its saltsDroperidolDrotrecogin alfaDulaglutideDuloxetine; its saltsDupilumabDurvalumabDutasterideEcothiopate iodideEctylureaEculizumabEdoxaban; its saltsEfalizumabEfanesoctocog alfaEfavirenz; its saltsEfinaconazole; its saltsElacestrant; its saltsEladocagene exuparvovecElapegademaseElbasvir; its saltsEletriptan; its saltsElosulfase alfaElotuzumabElranatamabEltrombopag; its salts; its esters; their saltsElvitegravir; its saltsEmbutramideEmicizumabEmpagliflozin; its saltsEmtricitabine; its saltsEmylcamateEnalapril; its saltsEnalaprilat; its saltsEncorafenib; its saltsEnfortumab vedotinEnfuvirtideEnoxacin; its salts; its estersEnoxaparin; its saltsEnoximoneEnrofloxacin; its salts; its estersEnsifentrine; its saltsEntacapone; its saltsEntecavir; its salts; its esters; their saltsEntrectinib; its saltsEnzalutamide; its saltsEpcoritamabEplerenoneEpoetin betaEprosartan; its saltsEptifibatide; its saltsEptinezumabEquecabtagene autoleucelErdafitinib; its saltsErenumabEribulin; its saltsErlotinib; its saltsErtugliflozin; its saltsEsmolol; its saltsEsomeprazole; its saltsEtafenone; its saltsEtamivan; its saltsEtanerceptEtelcalcetide; its saltsEthacrynic acid; its saltsEthambutol; its saltsEthchlorvynolEthinamateEthionamideEthoglucidEthoheptazine; its saltsEthosuximide; its saltsEthylnoradrenaline and its salts when contained in aerosol dispensersEtidronic acid; its salts; when contained in pharmaceutical productsEtilefrine; its saltsEtodolacEtofibrateEtomidate; its saltsEtoposide; its estersEtoricoxib; its saltsEtranacogene dezaparvovecEtrasimod; its salts; its esters; their saltsEtravirineEtretinateEtryptamine; its saltsEverolimus; its salts; its esters; their saltsEvocalcet; its salts; its esters; their saltsEvolocumabExemestane; its saltsExenatideEzetimibeFamciclovir; its saltsFampridine; its salts FaricimabFebuxostat; its salts; its esters; their saltsFelodipineFenbufenFencamfamin; its saltsFenclofenac; its saltsFendiline; its saltsFenfluramine; its saltsFenofibrateFenoprofen; its saltsFenoterol and its salts when contained in aerosol dispensersFenoxazoline; its saltsFentiazac; its saltsFenticonazole; its saltsFeprazoneFesoterodine; its salts; its esters; their saltsFezolinetant; its saltsFilgotinib; its saltsFilgrastimFinasterideFinerenone; its saltsFingolimod; its salts; its esters; their saltsFirocoxib; its saltsFitusiran; its saltsFlavoxate; its saltsFlecainide; its saltsFleroxacin; its salts; its estersFluanisoneFluconazole; its saltsFludarabine; its saltsFlufenamic acid; its salts; its esters; their saltsFlumazenilFlumethrin; its saltsFluorouracil; its derivativesFluoxetine; its saltsFlupenthixol; its saltsFluralaner; its saltsFlurbiprofenFluspirileneFlutamideFluvastatinFluvoxamine; its saltsFolinic acid; its saltsFondaparinux; its saltsFormestaneFormoterol and its salts when contained in aerosol dispensersFosaprepitant; its saltsFoscarnet trisodium hexahydrateFosinopril; its saltsFosnetupitant; its saltsFosphenytoin; its saltsFostamatinib; its saltsFotemustine; its saltsFremanezumabFruquintinib; its saltsFrusemideFulvestrantFulzerasib; its saltsFutibatinib; its saltsGabapentin; its saltsGadoxetic acid; its saltsGalcanezumabGallamine; its salts; its quaternary compoundsGallium-68; its salts; when contained in pharmaceutical productsGallopamil; its saltsGalsulfaseGanciclovir; its saltsGanirelix; its saltsGaradacimabGatifloxacin; its salts; its estersGefitinib; its saltsGemcitabine; its saltsGemfibrozilGemtuzumab ozogamicinGermanium-68; its salts; when contained in pharmaceutical productsGilteritinib; its saltsGimeracil; its saltsGlecaprevir; its saltsGlibenclamideGlibornurideGliclazideGlimepiride; its saltsGlipizideGliquidoneGlofitamabGlucagon; its saltsGlucarpidaseGlutathione; its salts; its derivatives; when contained in products for human parenteral administrationGlutethimide; its saltsGlycerol phenylbutyrateGlycopyrronium; its saltsGlymidineGolimumabGonadorelin; its saltsGoserelin; its saltsGozetotide; its saltsGranisetron; its saltsGrazoprevir; its saltsGrepafloxacin; its salts; its estersGuanabenz; its saltsGuanethidine; its saltsGuanfacine; its saltsGuselkumabHalofantrine; its saltsHalofuginone; its salts; except for incorporation in feed for chickens for fattening at levels not exceeding 3 parts per millionHaloperidol and other 4-substituted derivatives of N-(3-para-fluorobenzoylpropyl) piperidineHemin; its salts; its esters; their saltsHexamethylmelamineHexapropymateHexobendine; its saltsHuman chondrocytes when contained in advanced therapy products indicated for the repair of symptomatic articular cartilage defectsHuman cytomegalovirus immunoglobulinHydralazine; its saltsHydrazines, the following and their alpha-methyl derivatives—Benzyl hydrazinePhenethyl hydrazinePhenoxyethyl hydrazinetheir salts; their acyl derivatives; their saltsHydroxychloroquine; its saltsHydroxy-N,N-dimethyltryptamines; their esters and ethers; any salt of any substance falling within this itemHydroxyphenamateHydroxyureaHydroxyzine; its saltsIbandronic acid; its saltsIbritumomab tiuxetanIbrutinib; its saltsIcatibant; its salts; its esters; their saltsIcosapent ethyl when contained in pharmaceutical products indicated for the reduction of the risk of myocardial infarction, stroke, coronary revascularization, or unstable angina requiring hospitalizationIdarucizumabIdelalisib; its saltsIdursulfaseIdursulfase betaIfosfamideIloprost; its saltsImatinib; its saltsImdevimabImidapril; its saltsImigluceraseImipramine; its saltsImiquimod; its saltsInaticabtagene autoleucelInavolisib; its saltsInclisiran; its saltsIndacaterol; its salts; its esters; their saltsIndinavir; its saltsIndomethacin; its saltsIndoprofen; its saltsIndoramin; its saltsInfliximabInosineInosine pranobexInotuzumab ozogamicinInterferonsIodine-131; its salts; when contained in pharmaceutical productsIoflupane Iodine-123; its salts; when contained in pharmaceutical productsIpilimumabIprindole; its saltsIptacopan; its saltsIrbesartan; its saltsIrinotecan; its saltsIsatuximabIsavuconazole; its salts; its derivatives; their saltsIsoaminile; its saltsIsoetharine; its saltsIsofluraneIsoniazid; its salts; its derivatives; their salts; any compound with any substance falling within this itemIsoprenaline; its saltsIsopyrin; its saltsIsotretinoinIsoxicam; its saltsIsradipineItraconazole; its saltsIvabradine; its saltsIvosidenib; its saltsIxazomib; its saltsIxekizumabKetamine; its saltsKetanserin; its saltsKetoconazole, except when contained in preparations for external application onlyKetophenylbutazoneKetoprofen; its saltsKetorolac; its salts; its estersLabetalol; its saltsLabuvirtideLacidipine; its saltsLacosamide; its saltsLamivudine; its saltsLamotrigine; its saltsLanadelumabLanreotide; its saltsLansoprazoleLanthanum carbonateLapatinib; its saltsLaronidaseLaropiprant; its saltsLarotrectinib; its saltsLatanoprostene bunod; its saltsLazertinib; its saltsLebrikizumabLecanemabLedipasvir; its saltsLeflunomide; its saltsLemborexant; its saltsLenacapavir; its saltsLenalidomide; its saltsLenvatinib; its saltsLepirudin; its saltsLercanidipine; its saltsLetermovir; its salts; its esters; their saltsLetrozoleLeuprorelin; its saltsLevallorphan; its saltsLevetiracetam; its saltsLevosimendan; its saltsLidoflazineLignocaine; its salts; when in mixture with prilocaine or in mixture with the salts of prilocaine, and intended to be used for the treatment of premature ejaculationLignocaine; its salts; when in mixture with tetracaine (being an amino alcohol esterified with a derivative of benzoic acid) or in mixture with the salts of tetracaineLinaclotide; its saltsLinagliptin; its saltsLinezolid; its saltsLipegfilgrastimLiraglutideLisdexamfetamine; its saltsLisinopril; its saltsLithium carbonateLithium sulphateLixisenatideLomefloxacin; its salts; its estersLomustineLonazolac; its saltsLoncastuximab tesirineLopinavir; its saltsLoracarbef; its saltsLorcainide; its saltsLorlatinib; its saltsLosartan; its saltsLotilaner; its saltsLovastatin when contained in pharmaceutical productsLoxapine; its saltsLumefantrine; its saltsLurasidone; its saltsLurbinectedin; its saltsLuspaterceptLutetium-177; its salts; when contained in pharmaceutical productsLutetium (177Lu) oxodotreotide; its saltsLutetium (177Lu) vipivotide tetraxetan; its saltsLysuride; its saltsMacitentan; its saltsMangafodipir; its saltsMannomustine; its saltsMaprotiline; its saltsMaralixibat; its saltsMaraviroc; its saltsMarbofloxacin; its saltsMaribavir; its saltsMarstacimabMavacamten; its saltsMazdutideMazindolMebutamateMecamylamine; its saltsMeclofenamic acid; its saltsMeclofenoxate; its saltsMedigoxinMefenamic acid; its salts; its esters; their saltsMefloquine; its saltsMefrusideMelagatran; its salts; its derivatives; their saltsMelatonin; its salts; when contained in pharmaceutical products intended to be used for the treatment of insomniaMelitracen; its saltsMeloxicam; its saltsMemantine; its saltsMephenesin; its esters; their saltsMephenoxaloneMepirizole; its saltsMepivacaine; its saltsMepolizumabMeprobamateMercaptopurine; its salts; its derivatives; their saltsMeropenem; it saltsMertiatide; its salts; its esters; their saltsMesalazine; its saltsMescaline; its salts; other derivatives of phenethylamine formed by substitution in the aromatic ring; their saltsMesocarb; its saltsMetaflumizone; its saltsMetaraminol; its saltsMetaxaloneMetergolineMetformin; its saltsMethaqualone; its saltsMethimazole; its saltsMethixene; its saltsMethocarbamolMethoxsalenMethoxyfluraneMethoxyphenamine and its salts when contained in aerosol dispensersMethylaminoheptane and its salts when contained in aerosol dispensersMethyldopa; its esters; their saltsMethylnaltrexone; its saltsMethylpentynol; its derivativesalpha-Methylphenethylamine; beta-methylphenethylamine; alpha-ethylphenethylamine; beta-ethylphenethylamine; their optical isomers; any synthetic compound structurally derived from any of those substances by substitution in the aliphatic part or by ring closure therein (or by both such substitution and such closure) or by substitution in the aromatic ring (with or without substitution at the nitrogen atom), except hydroxyamphetamine, methoxy-phenamine, phenylpropanolamine, pholedrine and N-substituted derivatives of ephedrine; any salt of any substance falling within this itemMethylphenidate; its saltsMethypryloneMetipranolol; its saltsMetoclopramide; its saltsMetolazoneMetoprolol; its saltsMetronidazole; its salts; its esters; their saltsMetyrapone; its saltsMexiletine; its saltsMianserin; its saltsMibefradil; its saltsMicafungin; its salts; its estersMidodrine; its saltsMidostaurin; its saltsMifepristone; its salts; its esters; their saltsMigalastat; its saltsMiglitol; its saltsMilnacipran; its saltsMilrinone; its saltsMinoxidil, except when contained in preparations intended for external application only and the preparations contain not more than 5% of MinoxidilMirabegron; its salts; its esters; their saltsMirogabalin; its salts; its esters; their saltsMirtazapine; its saltsMitobronitolMitopodozide; its saltsMitotaneMitoxantrone; its saltsMivacurium; its saltsMizolastine; its saltsMobocertinib; its saltsMoclobemide; its saltsMoexipril; its saltsMofebutazone; its saltsMolgramostimMolindone; its saltsMolnupiravir; its saltsMolybdate (99Mo); its salts; when contained in pharmaceutical productsMomelotinib; its saltsMontelukast; its saltsMoracizine; its saltsMoroxydine; its saltsMosunetuzumabMoxifloxacin; its saltsMoxonidine; its saltsMuromonab-CD3Mustine and any other N-substituted derivative of di-(2-chloroethyl) amine; their saltsMuzolimineMycophenolic acid; its salts; its estersNabumetoneNadolol; its saltsNadroparin; its saltsNafarelin; its saltsNaftidrofuryl; its saltsNalbuphine; its saltsNaldemedine; its saltsNalidixic acidNalmefene; its saltsNalorphine; its saltsNaloxone; its saltsNaltrexone; its saltsalpha-Naphthylacetic acid; its saltsNaproxen; its saltsNaratriptan; its saltsNatalizumabNateglinide; its salts; its estersNaxitamabNebivolol; its saltsNecitumumabNefazodone; its saltsNefopam; its saltsNelfinavir; its saltsNeostigmine; its saltsNepafenac; its saltsNeratinib; its saltsNesiritideNetarsudil; its saltsNetupitant; its saltsNevirapine; its saltsNicardipine; its saltsNicergolineNicocodine; its saltsNicotinamide mononucleotide when contained as an active ingredient in products for human parenteral administrationNicotinic acid and its salts when contained in pharmaceutical products the recommended daily dose of which contains more than 200 mg of nicotinic acidNifedipineNifenazoneNiflumic acid; its saltsNifuratel; its saltsNifuroxazide; its saltsNilotinib; its saltsNilvadipineNimesulide; its saltsNimodipineNintedanib; its saltsNiraparib; its saltsNirmatrelvir; its saltsNirsevimabNisoldipineNitrendipineNitric oxide when contained in pharmaceutical productsNitrofural; its saltsNitrofurantoin; its saltsNitromethaqualone; its saltsNitrous oxide when contained in pharmaceutical productsNitroxoline; its saltsNivolumabNomifensine; its saltsNoramidopyrine methanesulphonate; its saltsNorcodeine; its salts; its esters and ethers; their saltsNorfloxacin; its salts; its estersNortriptyline; its saltsNusinersen; its saltsObinutuzumab; its antibody drug conjugatesOclacitinib; its saltsOcrelizumabOcriplasminOctreotide; its saltsOdevixibat; its salts; its esters; their saltsOfatumumabOfloxacin; its salts; its estersOlanzapine; its saltsOlaparib; its saltsOlaratumabOlmesartan; its salts; its esters; their saltsOlodaterol; its saltsOlsalazine; its saltsOmalizumabOmbitasvir; its saltsOmega-3 fatty acids; their salts; their esters; when contained in pharmaceutical products intended to be used for the treatment of hypertriglyceridaemiaOmidenepag; its salts; its esters; their saltsOnasemnogene abeparvovecOndansetron; its saltsOpipramol; its salts; its derivatives; their saltsOrciprenaline and its salts when contained in aerosol dispensersOrgoteinOrlistat; its salts; except when contained in a pharmaceutical product of which the recommended dose is a quantity of the product that contains not more than 60 mg of orlistat or its salts, taken 3 times a dayOrphenadrine; its saltsOseltamivir; its saltsOsimertinib; its saltsOteracil; its saltsOuabainOxaliplatin; its saltsOxanamideOxcarbazepine; its saltsOxprenolol; its saltsOxyfedrine; its saltsOxypertineOxyphenbutazoneOxytocinsOzanimod; its saltsPaclitaxelPalbociclib; its saltsPaliperidone; its saltsPalivizumabPalonosetron; its saltsPamidronate; its saltsPancuronium; its saltsPanitumumabPanobinostat; its saltsPantethine; its saltsPantoprazole; its salts; except when contained in oral preparations with 20 mg or less per solid dosage unit, indicated with the maximum daily dose of 20 mg for relief of heartburn symptoms associated with acid reflux in patients of 18 years old or above, and in packs with the maximum supply of 7 daysParaldehydeParamethadioneParecoxib; its saltsPargyline; its saltsParicalcitol; its salts; its esters; their saltsParitaprevir; its saltsParoxetine; its saltsPasireotide; its saltsPazopanib; its saltsPefloxacin; its salts; its estersPegaptanib; its saltsPegaspargasePegfilgrastimPegunigalsidase alfaPegvisomant; its saltsPembrolizumabPemetrexed; its salts; its esters; their saltsPemigatinib; its saltsPemirolast; its saltsPemoline; its saltsPempidine; its saltsPenbutolol; its saltsPenciclovir; its saltsPenicillamine; its saltsPentamidine; its saltsPentazocine; its saltsPentolinium; its saltsPentoxifylline; its saltsPerampanelPerflubutanePergolide; its saltsPerindoprilat; its salts; its esters; their saltsPertechnetate (99mTc); its salts; when contained in pharmaceutical productsPertuzumabPharmaceutical products for human parenteral administration containing the following or their salts, as active ingredients, except in mixture with insulin—Acetic acidAcetylcholineAcetylcysteineAdenosineAdrenalineAmbroxolAmino acidsAminophyllineAnti-D (rho) immunoglobulinsAntihistamine substancesBetiatideBicisateButetamateCaffeineCarnitineCations, the following, except in preparations containing any substance to which the Antibiotics Ordinance (Cap. 137) applies—CalciumChromiumCopperIronMagnesiumManganesePotassiumSeleniumSodium, except sodium chloride 0.9%ZincCholineCimetidineCiticolineDeoxycholic acidDextromethorphanDicycloverineDifenidolDiprophyllineDisofeninEphedrineExametazimeFish oilFluoresceinGalliumGelatinGlucosamineGlucoseGlycerolGlyceryl trinitrateGuaifenesinHeparinHyaluronic acidHyaluronidaseHydroxyethyl starchHyoscineIbuprofenIcodextrinIndigo carmineIndocyanine greenIodine norcholesterolIsosorbideLactic acidLecithinLignocaineMannitolMebrofeninMedronic acidMesnaMethoxyphenamineMethylene blueMethylephedrineNoradrenalineOlive oilOmeprazoleOxidronatePapaverineParacetamolPatent blue VPentetic acidPhenolPhenylephrineProcaineProtamineRanitidineRheniumSodium chloride 0.9%Sodium pyrophosphateSodium tetradecyl sulfateSodium thiosulfateSorbitolSoya oilStonefish antivenomSuccimerTerbutalineTetrakis copper tetrafluoroborateTetrofosminThalliumTinTriglyceridesTuberculinVitaminsWaterXantinol nicotinatePhenacemidePhenacetinPhenaglycodolPhenbutrazatePhencyclidine; its saltsPhenetidylphenacetinPhenformin; its saltsPhenindionePhenothiazine; its salts; its derivatives (except dimethoxanate and promethazine); their salts (except salts of dimethoxanate and promethazine); any compound with any substance falling within this itemPhenoxybenzamine; its saltsPhenprenazonePhenprobamatePhentolamine; its saltsPhenylbutazone; its salts2-Phenylcinchoninic acid; 2-salicylcinchoninic acid; their salts; their esters5-Phenylhydantoin; its alkyl and aryl derivatives; their saltsPhospholipid fraction; when contained in pharmaceutical products intended to be used as pulmonary surfactant for the treatment of respiratory distress syndromePibrentasvir; its saltsPicrotoxinPimecrolimusPimobendan; its saltsPioglitazone; its saltsPipecuronium; its saltsPipemidic acidPipobromanPiracetam; its saltsPirfenidone; its saltsPiromidic acid; its saltsPiroxicam, except when contained in preparations for external application onlyPirprofen; its saltsPirtobrutinib; its saltsPitavastatin; its salts; its esters; their saltsPitolisant; its saltsPituitary gland, the active principles of, other than corticotrophins, oxytocins and vasopressins, except when contained in inhalants or in preparations intended for external application onlyPizotifen; its saltsPlerixafor; its saltsPolatuzumab vedotinPolymethylenebistrimethylammonium saltsPomalidomide; its saltsPonatinib; its saltsPonesimod; its saltsPoractant alfaPorfimer; its saltsPosaconazole; its salts; its esters; their saltsPralidoxime; its saltsPralsetinib; its salts Pramipexole; its saltsPrasterone; its salts; when contained in pharmaceutical productsPrasugrel; its saltPravastatin; its salts; its estersPrazosin; its saltsPregabalin; its saltsPretomanid; its saltsPridinol; its saltsPrimaquine; its saltsPrimidonePrindolol; its saltsProbenecidProbucolProcainamide; its saltsProcarbazine; its saltsProcaterol and its salts when contained in aerosol dispensersProglumetacin; its saltsProguanil; its saltsPromoxolanePropafenone; its saltsPropanididPropiverine; its saltsPropofolPropoxur; its saltsPropranolol; its salts; its derivatives; their saltsPropylhexedrine and its salts, except when contained in inhalersPropylthiouracil; its saltsProquazoneProstaglandins, the following and their derivatives—AlprostadilBimatoprostDinoprostDinoprostoneEpoprostenolLatanoprostMisoprostolTravoprostUnoprostonetheir salts; their estersProthionamideProthipendyl; its saltsProtirelin; its saltsProtriptyline; its salts; its derivatives; their saltsPrucalopride; its saltsPrulifloxacin; its salts; its esters; their saltsPyrazinamidePyricarbate (Pyridinolcarbamate)Pyridostigmine; its saltsPyrimethaminePyriprole; its saltsPyrithyldioneQuetiapine; its saltsQuinagolide; its saltsQuinapril; its saltsQuinethazoneQuinidine; its saltsQuinine; its salts; its derivatives; their salts; except in preparations containing less than 10% of quinine, its salts, its derivatives or their saltsQuizartinib; its saltsRabeprazole; its saltsRacecadotril; its saltsRactopamine; its saltsRadium-223; its salts; when contained in pharmaceutical productsRaloxifene; its saltsRaltegravir; its saltsRaltitrexed; its saltsRamipril; its saltsRamucirumabRanibizumabRanolazine; its saltsRasagiline; its saltsRasburicase; its saltsRavulizumabReboxetine; its saltsRecombinant human erythropoietinRegadenoson; its saltsRegorafenib; its saltsRemdesivir; its saltsRemifentanil; its saltsRemoxipride; its saltsRepaglinide; its salts; its estersRepotrectinib; its saltsReproterol and its salts when contained in aerosol dispensersRescinnamineReteplaseRetigabine; its saltsRevefenacin; its saltsReviparin; its saltsRibavirin; its saltsRibociclib; its saltsRilmenidine; its saltsRilpivirine; its saltsRiluzole; its saltsRimegepant; its saltsRimiterol and its salts when contained in aerosol dispensersRimonabant; its saltsRiociguat; its saltsRipretinib; its saltsRisankizumabRisdiplam; its saltsRisedronic acid; its saltsRisperidoneRitlecitinib; its saltsRitodrine; its saltsRitonavir; its saltsRituximabRivaroxaban; its saltsRivastigmine; its saltsRizatriptan; its saltsRocuronium; its saltsRofecoxib; its saltsRoflumilast; its saltsRomiplostimRomosozumabRopeginterferon alfa-2bRopinirole; its saltsRopivacaine; its saltsRosiglitazone; its saltsRosoxacin; its saltsRosuvastatin; its saltsRotigotine; its saltsRoxadustat; its saltsRozanolixizumabRufinamide; its saltsRurioctocog alfa pegolRuxolitinib; its saltsSacituzumab govitecanSacubitril; its saltsSafinamide; its saltsSalbutamol and its salts, except when contained in aerosol dispensersSalmeterol and its salts when contained in aerosol dispensersSaquinavir; its saltsSarilumabSatralizumabSavolitinib; its saltsSaxagliptin; its saltsSebelipase alfaSecukinumabSelexipag; its saltsSelinexor; its saltsSelpercatinib; its saltsSelumetinib; its saltsSemaglutideSermorelin; its saltsSerplulimabSertindole; its saltsSertraline; its saltsSevelamer; its saltsSevofluraneSibutramine; its salts; any compound containing the chemical structure of 1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan-1-amine substituted to any degree or without substitution; its saltsSildenafil; its salts; any compound containing the chemical structure of 5-(2-ethoxyphenyl)-1-methyl-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-7(6H)-one substituted to any degree or without substitution; its saltsSilodosin; its saltsSiltuximabSimeprevir; its saltsSimvastatinSintilimabSiponimod; its salts; its esters; their saltsSirolimus; its saltsSitagliptin; its saltsSocazolimabSodium aurothiomalateSodium nitroprussideSodium zirconium cyclosilicateSofosbuvir; its saltsSolifenacin; its salts; its esters; their saltsSolriamfetol; its saltsSomapacitanSomatostatinSomatrogonSorafenib; its saltsSotalol; its saltsSotaterceptSotorasib; its saltsSparfloxacin; its salts; its estersSparteine; its saltsSpesolimabSpinosadSpironolactoneStavudine; its saltsStiripentol;

its saltsStreptokinaseStrontium ranelateStrophanthus, glycosides of StyramateSucroferric oxyhydroxideSugammadex; its salts; its esters; their saltsSulindacSulphinpyrazoneSulphonal; alkyl sulphonalsSulpirideSultoprideSumatriptan; its saltsSunitinib; its saltsSuprarenal gland, the active principles of, except adrenaline and noradrenaline (other than when contained in aerosol dispensers); their salts; except salts of adrenaline (other than when contained in aerosol dispensers); their derivatives; their salts; except hydrocortisone and its salts when contained in preparations intended for external application only at not more than 1%; except beclomethasone and its salts when contained in aerosol dispensers and except clobetasone butyrate when contained in preparations intended for external application only at not more than 0.05%Surufatinib; its saltsSutoprofen; its saltsSuxamethonium; its saltsSyrosingopineTacrine; its saltsTacrolimusTadalafil; its salts; any compound containing the chemical structure of 6-(Benzo[1,3]dioxol-5-yl)-2,3,6,7,12,12a-hexahydropyrazino[1’,2’:1,6] pyrido[3,4-b]indole-1,4-dione substituted to any degree or without substitution; its saltsTafamidis; its saltsTafasitamabTafluprostTafolecimabTagraxofuspTalazoparib; its saltsTaletrectinib; its saltsTalquetamabTamoxifen; its saltsTapentadol; its salts TarlatamabTazarotene; its saltsTazemetostat; its saltsTeclistamabTegaserod; its saltsTelbivudine; its saltsTelmisartan; its saltsTemozolomide; its saltsTemsirolimus; its salts; its estersTenapanor; its saltsTenecteplase; its saltsTeniposideTenofovir; its salts; its derivatives; their saltsTenoxicamTepotinib; its saltsTeprotumumabTerazosin; its saltsTerbinafine; its salts; except when contained in preparations for external application onlyTerbutaline and its salts when contained in aerosol dispensersTeriflunomide; its saltsTeriparatide; its saltsTerodiline; its saltsTertatolol; its saltsTetrabenazine; its saltsTetracosactide; its saltsTezepelumabThalidomide; its saltsTheofibrateThiacetazoneThiocarlide; its saltsThioctic acid; its salts; its derivatives; when contained in pharmaceutical productsThiotepaThymosin alpha 1Thyroid gland, the active principles of; their saltsThyrotropin alfaTiagabine; its salts; its esters; their saltsTianeptine; its salts; its esters; their saltsTiapride; its saltsTicagrelor; its salts; its esters; their saltsTiclopidine; its saltsTildrakizumabTiletamine; its saltsTilidate; its saltsTiludronic acid; its saltsTimolol; its saltsTinoridine; its saltsTinzaparin; its saltsTiotropium; its saltsTipiracil; its salts; when contained in pharmaceutical productsTiratricol; its saltsTirofiban; its saltsTirzepatideTisagenlecleucelTislelizumabTisotumab vedotinTixagevimabTizanidine; its saltsTocainide; its saltsTocilizumabTodralazine; its saltsTofacitinib; its saltsTofenacin; its saltsTolazamideTolbutamideTolcapone; its saltsTolfenamic acid; its saltsTolmetin; its saltsTolperisone; its saltsTolterodine; its saltsTolvaptanpara-Tolylmethylcarbinol nicotinic acid esterTopiramate; its saltsTopotecan; its saltsTorasemideToripalimabTrabectedin; its salts; its estersTramadol; its saltsTrametinib; its saltsTrandolapril; its saltsTranexamic acid, except when contained in toothpaste at 0.05% by weightTranylcypromine; its saltsTrastuzumab; its antibody drug conjugatesTrazodone; its saltsTremelimumabTreosulfan; its saltsTreprostinil; its salts; its esters; their saltsTretamine; its saltsTretinoinTriamterene; its saltsTriaziquoneTribromoethyl alcohol2,2,2-Trichloroethyl alcohol, esters of; their saltsTrientine; its salts; when contained in pharmaceutical productsTrifarotene; its salts; its esters; their saltsTrifluridine; its saltsTrilostaneTrimetaphan; its saltsTrimetazidine; its saltsTrimethadioneTrimethoprimTrimetozineTrimetrexate; its saltsTrimipramine; its saltsTrioxsalenTriptorelin; its saltsTromantadine; its salts; except when contained in pharmaceutical products labelled for the treatment of cold sores onlyTropisetron; its saltsTrospium chlorideTrovafloxacin; its salts; its derivatives; their saltsTucatinib; its saltsTulobuterol and its salts when contained in aerosol dispensersTybamateUmeclidinium; its saltsUpadacitinib; its saltsUrapidil; its saltsUrethaneUrokinaseUstekinumabValaciclovir; its saltsValdecoxib; its saltsValganciclovir; its saltsValnoctamideValproic acid; its salts; its estersValsartan; its saltsVandetanib; its saltsVardenafil; its salts; any compound containing the chemical structure of 2-(2-ethoxyphenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one substituted to any degree or without substitution; its saltsVarenicline; its saltsVasopressinsVecuronium; its saltsVedolizumabVelmanase alfaVelpatasvir; its saltsVemurafenib; its saltsVenetoclax; its saltsVenlafaxine; its saltsVeralipride; its saltsVerapamil; its saltsVericiguat; its saltsVernakalant; its saltsVerteporfin; its saltsVidarabine; its saltsVigabatrinVilanterol; its saltsVildagliptin; its saltsViloxazine; its saltsVindesine; its saltsVinorelbine; its saltsVismodegib; its saltsVitamin A and its esters when contained in pharmaceutical products the recommended daily dose of which contains not less than 10,000 international units of vitamin AVitamin D and its salts when contained in pharmaceutical products the recommended daily dose of which contains more than 1,000 international units of vitamin DVitamin K and its salts when contained in pharmaceutical products, except products with recommended daily dose of 120 mcg or less of vitamin K1 or K2 or its saltsVonoprazan; its saltsVorasidenib; its saltsVoriconazole; its saltsVortioxetine; its saltsVosoritideVoxilaprevir; its saltsVutrisiran; its saltsWarfarin; its saltsXamoterol; its saltsXylazine; its saltsZafirlukastZalcitabine; its saltsZaleplon; its saltsZanamivir; its saltsZanubrutinib; its saltsZidovudineZimelidine; its saltsZipeprol; its saltsZiprasidone; its saltsZofenopril; its saltsZolazepam; its saltsZolbetuximabZoledronic acid; its saltsZolmitriptan; its saltsZolpidem; its saltsZomepirac; its saltsZongertinib; its saltsZopicloneZoxazolamine; its salts(L.N. 137 of 1978; L.N. 369 of 1980; L.N. 415 of 1984; L.N. 129 of 1986; L.N. 130 of 1987; L.N. 197 of 1989; L.N. 128 of 1990; L.N. 262 of 1995; L.N. 130 of 1998; L.N. 22 of 1999; L.N. 202 of 1999; L.N. 30 of 2000; L.N. 138 of 2000; L.N. 235 of 2000; L.N. 296 of 2000; L.N. 51 of 2001; L.N. 143 of 2001; L.N. 173 of 2001; L.N. 287 of 2001; L.N. 56 of 2002; L.N. 112 of 2002; L.N. 132 of 2002; L.N. 170 of 2002; L.N. 237 of 2002; L.N. 73 of 2003; L.N. 179 of 2003; L.N. 181 of 2003; L.N. 273 of 2003; L.N. 276 of 2003; L.N. 74 of 2004; L.N. 135 of 2004; L.N. 191 of 2004; L.N. 11 of 2005; L.N. 72 of 2005; L.N. 114 of 2005; L.N. 212 of 2005; L.N. 25 of 2006; L.N. 122 of 2006; L.N. 178 of 2006; L.N. 223 of 2006; L.N. 277 of 2006; L.N. 41 of 2007; L.N. 98 of 2007; L.N. 143 of 2007; L.N. 208 of 2007; L.N. 239 of 2007; L.N. 61 of 2008; L.N. 113 of 2008; L.N. 197 of 2008; L.N. 234 of 2008; L.N. 282 of 2008; L.N. 90 of 2009; L.N. 147 of 2009; L.N. 199 of 2009; L.N. 258 of 2009; L.N. 11 of 2010; L.N. 32 of 2010; L.N. 81 of 2010; L.N. 104 of 2010; L.N. 140 of 2010; L.N. 23 of 2011; L.N. 127 of 2011; L.N. 33 of 2012; L.N. 124 of 2012; L.N. 179 of 2012; L.N. 19 of 2013; L.N. 94 of 2013; L.N. 98 of 2013; L.N. 125 of 2013; L.N. 158 of 2013; L.N. 195 of 2013; L.N. 39 of 2014; L.N. 134 of 2014; 2 of 2015 s. 67; L.N. 34 of 2015; L.N. 67 of 2015; L.N. 100 of 2015; L.N. 193 of 2015; L.N. 235 of 2015; L.N. 40 of 2016; L.N. 51 of 2016; L.N. 83 of 2016; L.N. 119 of 2016; L.N. 172 of 2016; L.N. 11 of 2017; L.N. 38 of 2017; L.N. 119 of 2017; L.N. 140 of 2017; L.N. 167 of 2017; L.N. 10 of 2018; L.N. 42 of 2018; L.N. 80 of 2018; L.N. 136 of 2018; L.N. 191 of 2018; L.N. 210 of 2018; L.N. 228 of 2018; L.N. 3 of 2019; L.N. 10 of 2019; L.N. 30 of 2019; L.N. 145 of 2019; L.N. 184 of 2019; L.N. 14 of 2020; L.N. 41 of 2020; L.N. 126 of 2020; E.R. 5 of 2020; L.N. 212 of 2020; L.N. 252 of 2020; L.N. 104 of 2021; L.N. 218 of 2021; L.N. 1 of 2022; L.N. 19 of 2022; L.N. 33 of 2022; L.N. 122 of 2022; L.N. 194 of 2022; L.N. 232 of 2022; L.N. 10 of 2023; L.N. 108 of 2023; L.N. 138 of 2023; L.N. 9 of 2024; L.N. 73 of 2024; L.N. 105 of 2024; L.N. 135 of 2024; L.N. 177 of 2024; L.N. 5 of 2025; L.N. 38 of 2025; L.N. 116 of 2025; L.N. 161 of 2025; L.N. 211 of 2025; L.N. 13 of 2026; L.N. 42 of 2026)Division B(L.N. 41 of 2007) Dinitronaphthols; dinitrophenols; dinitrothymolsHexachlorophane; preparations containing more than 0.1% for human or animal use in aerosol containers; preparations in the form of a cake, tablet or bar of soap for human use containing more than 2%; preparations in the form of soaps or shampoos for animal use containing more than 2%; medicinal preparations for human or animal use (except those for oral administration to sheep or cattle for liver fluke disease) containing more than 0.75%.(L.N. 262 of 1995) Schedule 4 [reg. 14]Statement of Particulars as to Proportion of Poison in Certain Cases Permitted by Regulation 14(a) Division A(L.N. 41 of 2007) Name of Poison Particulars Alkaloids Aconite, alkaloids of The proportion of any one alkaloid of aconite that the preparation would be calculated to contain on the assumption that all the alkaloids of aconite in the preparation were that alkaloid. Belladonna, alkaloids of Calabar bean, alkaloids of Coca, alkaloids of Colchicum, alkaloids of Ephedra, alkaloids of Ergot, alkaloids of Gelsemium, alkaloids of Lobelia, alkaloids of Pilocarpus, alkaloids of Pomegranate, alkaloids of Quebracho, alkaloids of, other than the alkaloids of red quebracho Sabadilla, alkaloids of Stavesacre, alkaloids of Veratrum, alkaloids of Yohimba, alkaloids of } The same as above, with the substitution for the reference to aconite of a reference to balladonna, calabar bean or such other of the said poisons as the case may require. (L.N. 137 of 1978) Antimonial poisons The proportion of antimony trioxide (Sb2O3) or antimony pentoxide (Sb2O5) that the preparation would be calculated to contain on the assumption that the antimony (Sb) in the poison had been wholly converted into antimony trioxide or antimony pentoxide as the case may be. Arsenical poisons The proportion of arsenic trioxide (As2O3) or arsenic pentoxide (As2O5) that the preparation would be calculated to contain on the assumption that the arsenic (As) in the poison had been wholly converted into arsenic trioxide or arsenic pentoxide as the case may be. Digitalis, glycosides of; other active principles of digitalis The number of units of activity as defined in the British Pharmacopoeia contained in a specified quantity of the preparation. Hydrocyanic acid ; cyanides other than ferrocyanides and ferricyanides The proportion of hydrocyanic acid (HCN) that the preparation would be calculated to contain on the assumption that the cyanides in the poison had been wholly converted into hydrocyanic acid. Insulin The number of units of activity as defined in the British Pharmacopoeia contained in a specified quantity of the preparation. Lead, compounds of, with acids from fixed oils The proportion of lead oxide (PbO) that the preparation would be calculated to contain on the assumption that the lead in the poison had been wholly converted into lead oxide. Mercury, organic compounds of The proportion of organically-combined mercury (Hg) contained in the preparation. Nux Vomica The proportion of strychnine contained in the preparation. Opium The proportion of morphine contained in the preparation. Phenols The proportion of phenols (added together) contained in the preparation. Compounds of a phenol with a metal The proportion of phenols (added together) that the preparation would be calculated to contain on the assumption that the compounds of phenols with a metal had been wholly converted into the corresponding phenols. Pituitary gland, the active principles of Either— (a) The number of units of activity as defined in the British Pharmacopoeia contained in a specified quantity of the preparation; or (b) the proportion of pituitary gland, or of anterior or of posterior lobe of the gland, as the case may be, contained in the preparation; or (c) the amount of pituitary gland, or of anterior or of posterior lobe of the gland, as the case may be, from which a specified quantity of the preparation was obtained, together with an indication whether the amount relates to fresh or to dried gland substance. Strophanthus, glycosides of The amount of Standard Tincture of Strophanthus as defined in the British Pharmacopoeia 1948 which possesses the same activity as a specified quantity of the preparation when assayed by the method described in the said Pharmacopoeia. Suprarenal gland, the active principles of; their salts; their derivatives; their salts Either— (a) the proportion of Suprarenal gland or of the cortex or of the medulla of the gland, as the case may be, contained in the preparation; or (b) the amount of Suprarenal gland, or of the cortex or of the medulla of the gland, as the case may be, from which a specified quantity of the preparation was obtained, together with an indication whether the amount relates to fresh or to dried gland substance. Thyroid gland, the active principles of; their salts Either— (a) the proportion of thyroid gland contained in the preparation; or (b) the amount of thyroid gland from which a specified quantity of the preparation was obtained together with an indication whether the amount relates to fresh or to dried gland. Division B(L.N. 41 of 2007) Name of Poison Particulars Barium, salts of The proportion of one particular barium salt which the preparation would be calculated to contain on the assumption that the barium (Ba) in the preparation had been wholly converted into that salt. Potassium hydroxide The proportion of potassium monoxide (K2O) which the preparation would be calculated to contain on the assumption that the potassium hydroxide in the preparation had been wholly converted into potassium monoxide. Sodium hydroxide The proportion of sodium monoxide (Na2O) which the preparation would be calculated to contain on the assumption that the sodium hydroxide in the preparation had been wholly converted into sodium monoxide. Schedule 5 [reg. 15](2 of 2015 s. 68)Texts Prescribed by Regulation 15 for Purposes of Section 27(c) or (ca) (2 of 2015 s. 68)(Format changes—E.R. 1 of 2016) 1. To be labelled with the text “Caution. It is dangerous to take this preparation except under medical supervision.” 「注意：非經醫生指示，服食此藥有危險。」——Medicines made up ready for the internal treatment of human ailments and containing insulin 2. To be labelled with the text “Caution. It is dangerous to exceed the stated dose.” 「注意：服食過量有危險。」——Medicines (other than medicines containing insulin and medicines mentioned in paragraph 8 of this Schedule) made up ready for the internal treatment of human ailments except in the case of a substance included in Schedule 1 (E.R. 3 of 2015; E.R. 5 of 2020) 3. To be labelled with the text “Poison. For animal treatment only.” 「毒藥：祇限醫治禽畜用。」——Medicines made up ready for the treatment of animals 4. To be labelled with the text “Caution. This preparation may cause serious inflammation of the skin in certain persons and should be used only in accordance with expert advice.” 「注意：此藥可使某些人士皮膚嚴重發炎，須照專家指示使用。」——Preparations for the dyeing of hair containing phenylene diamines, toluene diamines or other alkylated-benzene diamines or their salts 5. To be labelled with the text “Caution. This substance is caustic.” 「注意：此物質有腐蝕作用。」——Potassium hydroxide, sodium hydroxide, and articles containing either of those substances 6. To be labelled with the text “Caution. This substance is poisonous. The inhalation of its vapour, mist, spray or dust may have harmful consequences. It may also be dangerous to let it contact the skin or clothing.” 「注意：此物質有毒。吸入其蒸氣、煙霧、噴霧或粉末，可能有害。如觸及皮膚或衣服，亦可能有危險。」——Diethyl para-nitrophenyl phosphateOrganic compounds of mercury in aerosols (L.N. 195 of 1977; L.N. 262 of 1995) 7. To be labelled with the text “Caution. This preparation should be administered only under medical supervision. The vapour is dangerous.” 「注意：此藥之蒸氣有危險，須經醫生指示，方可使用。」——Medicines made up ready for the internal or external treatment of human ailments and containing dyflos 8. To be labelled with the text “Caution. This may cause drowsiness. If affected, do not drive or operate machinery.” 「注意：此藥可使人昏昏欲睡，服後如有此情形，不得駕駛或動用機械。」——Medicines made up ready for the internal treatment of human ailments containing any of the antihistamine substances (except Astemizole, Bilastine, Cetirizine, Desloratadine, Fexofenadine, Loratadine and Terfenadine), their salts or their compounds with any other substance (L.N. 262 of 1995; L.N. 202 of 1999; L.N. 132 of 2002; L.N. 66 of 2015) 9. To be labelled with the text “Caution. Not to be taken internally.” 「注意：忌食。」——Preparations for external use containing mercuric ammonium chlorides 10. (a) To be labelled with the text “Not to be used for babies” 「嬰兒禁用。」 or “This preparation should not be administered, except on medical advice, to a child under 2 years of age.” 「非經醫生指示，此藥不可用於兩歲以下兒童。」—— Hexachlorophane (b) To be labelled with the text “Not to be used for whole body bathing except on medical advice.” 「非經醫生指示不可用作全身沐浴。」—— Soap for human use containing 2% or more of hexachlorophane (c) To be labelled with the text “For animal treatment only.” 「祇限醫治禽畜用。」—— Medicine containing hexachlorophane for the treatment of animal (d) To be labelled with the text “Not for use for lactating cattle.” 「不得用於授乳牛隻。」—— Medicine containing hexachlorophane for oral administration for the prevention or treatment of liver fluke disease in cattle (e) To be labelled with the text “Protective clothing must be worn by the operator when this product is being administered.” 「使用此藥之人員必須穿着防護性衣服。」—— Medicine containing hexachlorophane for oral administration for the prevention or treatment of liver fluke disease in sheep or cattle 11. (Repealed L.N. 262 of 1995) 12. To be labelled with the text “Prescription Drug 處方藥物”—Medicine containing a poison included in Schedule 3 (2 of 2015 s. 68; E.R. 1 of 2016) 13. To be labelled with the text “Drug under Supervised Sales 監督售賣藥物”—Medicine containing a poison included in Part 1 of the Poisons List but not containing a poison included in Schedule 3 (2 of 2015 s. 68; E.R. 1 of 2016)(2 of 2015 s. 68) Schedule 6 [reg. 4(2)]Poisons Exempted by Regulation 4 from Labelling Provisions when Sold or Supplied in Certain Circumstances Division A(L.N. 41 of 2007) Antimony, chlorides of; oxides of; sulphides of; antimonates; antimonites Chloroform Glyceryl trinitrate Lead acetates; compounds of lead with acids from fixed oils Mercuric chloride; mercuric iodide; organic compounds of mercury Mercury, nitrates of; oxides of Oxalic acid; metallic oxalates Phenols; compounds of phenol with a metal Picric acid Division B(L.N. 41 of 2007)Alkali fluorides Ammonia Dinitronaphthols; dinitrophenols; dinitrothymols Formaldehyde Formic acid Hydrochloric acid Hydrofluoric acid; sodium silicofluoride Nitric acid Nitrobenzene meta-Nitrophenol; ortho-nitrophenol; para-nitrophenol Phosphorus, yellow Potassium hydroxide Sodium hydroxide Sulphuric acid(L.N. 262 of 1995; E.R. 5 of 2020) Schedule 7 [reg. 21]Poisons Required by Regulation 21 to be Specially Labelled for Transport Division A(L.N. 41 of 2007) Arsenical poisons Diethyl para-nitrophenyl phosphate Hydrocyanic acid; cyanides, other than ferrocyanides and ferricyanides, except preparations containing less than the equivalent of 0.1%, weight in weight, of hydrocyanic acid (HCN) Nicotine Strychnine; its salts Thallium, salts of(L.N. 195 of 1977) Division B(L.N. 41 of 2007) Barium, salts of, except barium sulphate (L.N. 137 of 1978; L.N. 262 of 1995) Schedule 8 Forms 1—5 (Repealed 2 of 2015 s. 69) _ Form 5A (Repealed 2 of 2015 s. 69) _ Forms 6—10 (Repealed 2 of 2015 s. 69) _ Form 11 (Spent) _ Forms 12—16 (Repealed 2 of 2015 s. 69) _ Form 17 [reg. 41] Form of Logo Prescribed for Section 13A (2 of 2015 s. 69) Schedule 9 [regs. 24A, 26, 29, 30D, 30E, 36, 36B, 36D & 41](2 of 2015 s. 70)Fees Item Particular Fee $ 1. Examination in each subject prescribed by the Board (L.N. 60 of 2001) 1,110 2. Issue of a certificate of registration as a pharmacist (L.N. 60 of 2001) 790 3. Issue of a duplicate certificate of registration as a pharmacist 395 4. Registration of premises of an authorized seller of poisons 1,000 5. Renewal of registration of premises of an authorized seller of poisons (2 of 2015 s. 70) 1,310 6. Application for entry on the list of listed sellers of poisons 455 7. Retention on the list of listed sellers of poisons, each year 430 8. Any alteration to the register of premises or to the list of listed sellers 250 9. An annual wholesale dealer licence (2 of 2015 s. 70) 625 10. Annual licence for manufacturers 2,680 10A. Certificate of registration of an authorized person (2 of 2015 s. 70) 1,420 10B. Renewed certificate of registration of an authorized person (2 of 2015 s. 70) 1,420 11. Application for registration of a product 1,100 12. Certificate of registration of a product 1,370 13. Renewal of a certificate of registration of a product 575 14. Free Sale Certificate of Pharmaceutical Product 180 15. Certificate of Pharmaceutical Product 140 16. Certificate and Interim Certificate for Manufacturer 2,020 17. Annual practising certificate for a registered pharmacist (34 of 1995 s. 43; L.N. 60 of 2001) 520 18. Application for a clinical trial or medicinal test 1,420 19. Certificate for clinical trial or medicinal test 1,420 20. (Repealed 2 of 2015 s. 70) 21. Duplicate of any certificate 220 22. Issue of a certificate of good standing (L.N. 60 of 2001) 415 (L.N. 597 of 1994; L.N. 214 of 1997; L.N. 126 of 2006) Schedule 10 [reg. 2A]Poisons List 1. Interpretation (1) In the Poisons List, a reference to a substance includes—(a) that substance prepared either from natural sources or artificially; and(b) that substance when contained as such in a preparation, solution, mixture or natural substance.(2) In the Poisons List— derivative (衍生物) means an organic compound of the following descriptions— (a) it is related to another organic compound (parent compound) because it has— (i) the same elemental ring, chain, nucleus or skeleton; and (ii) similar pharmaceutical activity; (b) it may have a molecular weight which may be the same as, or higher or lower (for example, after formation of a derivative by the process commonly known as dehydrogenation) than that of the parent compound; and (c) its preparation may or may not require the presence of the parent compound. (3) In the Poisons List—(a) substances listed in Divisions A are those whose uses are essentially medicinal; and(b) substances listed in Divisions B are not normally used medicinally. 2. Poisons List The Poisons List is set out in the Table. Table Part 1 Division A Abacavir; its saltsAbataceptAbciximabAbemaciclib; its saltsAbiraterone; its saltsAbrocitinib; its saltsAcalabrutinib; its saltsAcamprosate; its saltsAcarbose; its saltsAcebutolol; its saltsAceclofenac; its saltsAcemetacin; its saltsAcetanilide; alkyl acetanilidesAcetazolamide; its saltsAcetohexamideAcetorphine; its salts; its esters and ethers; their saltsAcetylcarbromalAcetyldihydrocodeine; its saltsAciclovir; its saltsAcipimox; its saltsAcitretin; its salts; its estersAclidinium; its saltsAdagrasib; its saltsAdalimumabAdapalene; its salts; its estersAdefovir; its salts; its esters; their saltsAfatinib; its saltsAfliberceptAfoxolaner; its saltsAgalsidase alfaAgalsidase betaAgomelatine; its saltsAlclofenac; its complexesAlcuronium; its saltsAldesleukinAlectinib; its saltsAlefaceptAlemtuzumabAlendronic acid; its saltsAlfacalcidol; its saltsAlfuzosin; its saltsAlglucosidase alfaAlirocumabAliskiren; its salts; its esters; their saltsAlizapride; its saltsAlkaloids, the following; their quaternary compounds; any salt, simple or complex, of any substance falling within the following—Aconite, alkaloids ofAtropineBelladonna, alkaloids ofBrucineCalabar bean, alkaloids ofCoca, alkaloids ofCocaineCodeine; its esters and ethersColchicum, alkaloids of; their saltsConiineCotarnineCurare, alkaloids of; curare basesEcgonine; its esters and ethersEmetineEphedra, alkaloids ofErgot, alkaloids ofGalantamineGelsemium, alkaloids ofHomatropineHyoscineHyoscyamineLobelia, alkaloids ofMorphine; its esters and ethersNicotine (except when contained in (a) chewing gum or lozenges, intended to be used in nicotine replacement therapy and containing not more than 4 mg of Nicotine per piece; or (b) patches for external application, intended to be used in nicotine replacement therapy); any compound containing the chemical structure of 3-(1-methylpyrrolidin-2-yl)pyridine substituted to any degree or without substitutionNux Vomica, alkaloids ofPapaverinePilocarpus, alkaloids ofPomegranate, alkaloids ofQuebracho, alkaloids ofRauwolfia, alkaloids of; their derivativesSabadilla, alkaloids ofStavesacre, alkaloids ofStrychnineThebaineVeratrum, alkaloids ofVinca, alkaloids ofYohimba, alkaloids ofAllergen extract of Dermatophagoides farinaeAllergen extract of Dermatophagoides pteronyssinusAllopurinolAllylisopropylacetylureaAllylprodine; its saltsAlmitrine; its saltsAlogliptin; its saltsAlpelisib; its saltsAlphadolone; its estersAlphaxaloneAlprenolol; its saltsAlteplaseAlufibrateAmantadine; its saltsAmbrisentan; its salts; its esters; their salts Amidopyrine; its saltsAmifostine; its saltsAmiloride; its saltsAmineptine; its saltsAmino-alcohols esterified with benzoic acid, phenylacetic acid, phenylpropionic acid, cinnamic acid or the derivatives of these acids; their salts (except procaine when in a preparation containing any substance to which the Antibiotics Ordinance (Cap. 137) for the time being applies)para-Aminobenzenesulphonamide; its salts; derivatives of para-aminobenzenesulphonamide having any of the hydrogen atoms of the para-amino group or of the sulphonamide group substituted by another radical; their saltspara-Aminobenzoic acid, esters of; their salts; except benzocaine when contained in condomsAminoglutethimide5-Aminolevulinic acid; its salts; its derivatives; their saltsAminophylline; its saltsAminopterin; its derivativesAminorex; its saltspara-Aminosalicylic acid; its salts; its derivatives; their salts; any compound with any substance falling within this itemAmiodarone; its saltsAmisulpride; its saltsAmitriptyline; its saltsAmivantamabAmlodipine; its saltsAmrinoneAmsacrine; its saltsAmyl nitriteAmylene hydrateAnagrelide; its saltsAnastrozole; its saltsAndexanet alfaAndrogenic, oestrogenic and progestational substances, the following—BenzoestrolDerivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their estersSteroid compounds with androgenic or oestrogenic or progestational activity; their esters; except when contained in a preparation intended to be taken orally for contraceptive purposes only and each dose of the preparation contains not more than the following—0.15 mg of Desogestrel;3.00 mg of Drospirenone;0.05 mg of Ethinyloestradiol;0.10 mg of Gestodene;0.25 mg of Levonorgestrel;2.50 mg of Lynoestrenol;0.05 mg of Mestranol;1.00 mg of Norethisterone;0.25 mg of Norgestimate; and0.50 mg of NorgestrelAnidulafungin; its salts; its esters; their saltsAnifrolumabAnileridine; its saltsAnistreplaseAntihistamine substances, the following; their salts; any compound with any substance falling within this item—AcrivastineAntazolineAstemizoleAzelastineBilastineBromodiphenhydramineBuclizineChlorcyclizineCyclizineDesloratadine3-Di-n-butylaminomethyl-4,5,6-trihydroxyphthalideDimethothiazineDiphenhydramineDoxylamineEbastineFexofenadineIsothipendylKetotifenLoratadine (except Loratadine; its salts; when contained in pharmaceutical products labelled for the relief of the symptoms of allergic rhinitis only)MebhydrolinMeclozineMethdilazinePhenindaminePromethazineTerfenadineThenalidineTrimeprazineTripelennamineSubstances being tetra-substituted N derivatives of ethylene-diamine or propylenediamineAntihistamine substances other than the above; their salts; any compounds with such substances; when contained in preparations for parenteral useAntilymphocyte ImmunoglobulinsAntimony, chlorides of; organic compounds of; antimonates; antimonitesAntisera, antitoxins, immunoglobulins and vaccines—(a) the following—Bacillus Calmette-Guérin (BCG)Digoxin-specific antibody fragmentsMeningococcal vaccinesNormal immunoglobulinsPneumococcal vaccinesRotavirus vaccinesSnake venom antiseraStaphylococcal vaccinesStreptococcal vaccines;(b) directed against the following diseases, viruses or organisms—Bordetella speciesBotulismCanine infectious diseaseCholeraDengue feverDiphtheriaFeline calicivirusFeline Chlamydia psittaciFeline immunodeficiency virusFeline leukemia virusFeline panleukopenia virusFeline rhinotracheitis virusHaemophilus influenzae type bHepatitis AHepatitis BHerpes simplexHerpes zosterHuman papillomavirusInfluenzaJapanese encephalitisMeaslesMumpsPertussisPlaguePoliomyelitisRabiesRespiratory syncytial virusRubellaSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)TetanusTyphoidVaricellaYellow feverAntithymocyte Immunoglobulin Apalutamide; its salts Apixaban; its salts Apomorphine; its salts; its quaternary compounds Apraclonidine; its salts Apremilast; its salts Aprepitant; its salts Aprindine; its salts Aripiprazole Arsenic trioxide when contained in pharmaceutical productsArsenical substances, the following: halides of arsenic; organic compounds of arsenic; oxides of arsenic; sulphides of arsenic; arsenates; arsenites; thioarsenatesArtemether; its salts Articaine; its salts Asciminib; its saltsAsenapine; its salts; its isomers Asfotase alfaAsunaprevir; its salts Atazanavir; its salts Atenolol; its salts Atezolizumab AtogepantAtomoxetine; its salts Atorvastatin; its salts Atosiban; its salts Atovaquone Atracurium besylate Atrasentan; its salts; its esters; their saltsAuranofin Avacopan; its saltsAvalglucosidase alfaAvanafil; its salts Avapritinib; its saltsAvatrombopag; its salts; its esters; their saltsAvelumab Axicabtagene ciloleucelAxitinib; its salts Azacitidine; its salts Azacyclonol; its salts Azapropazone Azauridine; its derivatives Azelaic acidAzilsartan; its salts; its esters; their salts Aziridine; its derivatives Baclofen Baloxavir; its salts; its esters and ethers; their salts Bambuterol; its salts Barbituric acid; its salts; its derivatives; their salts; any compound with any substance falling within this itemBaricitinib; its salts Basiliximab; its salts Becaplermin; its salts Bedaquiline; its salts Befunolol; its salts Belantamab mafodotinBelimumab Belumosudil; its saltsBelzutifan; its saltsBemiparin; its salts Bempedoic acid; its salts; its esters; their saltsBenactyzine; its salts Benazepril; its salts BenmelstobartBenoxaprofen; its saltsBenralizumab Benserazide; its salts Benzbromarone Benzethidine; its salts Benzhexol; its salts Benzoylmorphine; its salts Benzquinamide Benztropine and its homologues; their salts Benzydamine; its salts Benzylmorphine; its salts Besifloxacin; its salts; its esters; their salts Betahistine; its saltsBetaxolol; its salts Bethanidine; its salts Bevacizumab Bexarotene; its saltsBezafibrate Bezitramide; its saltsBicalutamide; its salts Bictegravir; its salts Bifonazole; its salts BimekizumabBinimetinib; its saltsBiperiden; its salts Biphenylacetic acid; its salts; its esters N-[4,4-Bis(para-fluorophenyl)butyl]piperidine,4-substituted derivatives of; their saltsBisoprolol; its saltsBitolterol; its saltsBivalirudin; its saltsBlinatumomabBlood products derived from human blood or manufactured by biotechnology, the following—Albumin Antithrombins Blood clotting factors Fibrin Fibrinogen Plasma protein fractions Thrombin Boceprevir; its salts Bortezomib Bosentan; its salts Botulinum toxin complexes Brentuximab vedotin Bretylium tosylate Brexpiprazole; its salts Brigatinib; its salts Brimonidine; its salts Brinzolamide; its salts Brivaracetam; its salts Brodalumab BrolucizumabBromocriptine; its salts Bromvaletone Broncho-Vaxom Brotizolam Bucolome Bufexamac Buformin; its salts Bumadizone; its salts Bumetanide; its salts; its derivatives; their salts Bupivacaine; its salts Bupranolol; its salts Buprenorphine; its salts Bupropion; its salts Burosumab Buserelin; its salts Buspirone; its salts Busulphan; its salts Butorphanol; its salts Butylchloral hydrate Cabazitaxel; its salts; its esters; their salts Cabergoline; its salts Cabotegravir; its saltsCabozantinib; its salts CalcifediolCalcipotriol; its salts Calcitriol; its salts Canagliflozin; its salts Canakinumab Candesartan; its salts; its esters; their salts Cannabidiol; its salts; when contained in pharmaceutical productsCannabinol and its tetrahydro or hexahydro derivatives; their 3-alkyl homologues; any ester or ether of any substance falling within this itemCannabis; the resin of cannabis; extracts of cannabis; tinctures of cannabis; cannabin tannateCantharidin; cantharidates Capecitabine; its salts Capivasertib; its saltsCapmatinib; its saltsCaptodiamine; its salts Captopril Caramiphen; its salts Carbachol Carbamazepine Carbidopa; its salts Carbimazole; its salts Carboplatin Carbromal Carbutamide Carfilzomib; its salts Carglumic acid; its salts; its esters; their saltsCariprazine; its saltsCarisoprodol Carmustine Carperidine; its salts Carprofen; its salts Carteolol; its salts Carvedilol; its salts CasirivimabCaspofungin; its salts Catequentinib (Anlotinib); its saltsCedazuridine; its saltsCelecoxib; its salts Celiprolol; its salts CemiplimabCenobamate; its saltsCeritinib; its salts Cerivastatin; its salts Certolizumab pegol Cetrorelix; its salts; its esters; their salts Cetuximab Chlofenamic acid; its salts Chloral; its addition and its condensation products; any compound with any substance falling within this itemChlordiazepoxide; its saltsChlormethiazole; its saltsChlormezanoneChloroformChloroquine; its salts; its derivatives; their saltsChlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonamide 1,1-dioxide, whether hydrogenated or not; their saltsChlorphenoxamine; its saltsChlorphentermine; its saltsChlorpropamide; its saltsChlorprothixene and other derivatives of 9-methylenethiaxanthen; their saltsChlorthalidone and other derivatives of ortho-chlorobenzenesulphonamideChlorzoxazone Chorionic Gonadotrophin Chymopapain Cicletanine; its salts Cidofovir; its salts Cilazapril; its salts CilgavimabCilostazol; its salts Cinacalcet; its salts Cinepazide; its salts Ciprofibrate; its salts Ciprofloxacin; its salts; its esters Cisapride Cisatracurium besylate Cisplatin Citalopram; its salts Citicoline; its salts; when contained in pharmaceutical products intended to be used for the treatment of cognitive and neurological disorders associated with cerebrovascular disease or brain injury, or bothCladribine Clioquinol Clobazam Clodronic acid; its salts; its esters Clofarabine; its salts; its esters; their salts Clofazimine; its salts Clofibrate Clomiphene; its salts Clomipramine; its salts; its derivatives; their salts Clonidine; its salts Clonitazene; its salts Clopidogrel; its salts Clorexolone Cloridarol Clorprenaline; its salts Clothiapine Clotrimazole; its salts; except when contained in pharmaceutical products labelled only for the treatment of tinea pedis or tinea cruris, or bothClozapine; its salts Cobicistat; its salts Cobimetinib; its salts Codergocrine mesilateColaspase Colfosceril; its salts Collagen, purified Contrast media, the following; their salts; any compound with any substance falling within this item; when contained in preparations for parenteral use—Acetrizoic acid Diatrizoic acid Ferucarbotran Gadobenic acid Gadobutrol Gadodiamide Gadopentetic acid Gadoteric acid Iobitridol Iocarmic acid Iocetamic acid Iodamide Iodipamide Iodised oil Iodixanol Iodoxamic acid Ioglicic acid Ioglycamic acid Iohexol Iomeprol Iopamidol Iopanoic acid Iophendylate Iopromide Iothalamic acid Iotrolan Iotroxic acid Ioversol Ioxaglic acid Ioxitalamic acid Ipodic acid Metrizamide Propyliodone Sulphur hexafluoride Tyropanoic acid Corifollitropin alfaCorticorelin; its saltsCorticotrophinsCorynebacterium parvumCreosote obtained from woodCrisaborole; its saltsCrizotinib; its saltsCroton, oil of4-Cyano-2-dimethylamino-4,4-diphenylbutane; its salts4-Cyano-1-methyl-4-phenylpiperidine; its saltsCyclarbamateCyclobenzaprine; its saltsCyclofenil1-Cyclohexyl-3-para-toluenesulphonylurea (tolcyclamide)Cyclosporin A Cycrimine; its salts Cytarabine; its salts Dabigatran etexilate; its salts Dabrafenib; its salts Dacarbazine Daclatasvir; its salts Daclizumab Dacomitinib; its salts Dalteparin; its salts Danicopan; its saltsDapagliflozin; its salts Dapoxetine; its salts Dapsone Daratumumab Darbepoetin alfa Daridorexant; its salts Darifenacin; its salts Darolutamide; its saltsDarunavir; its salts Dasabuvir; its salts Dasatinib; its salts Datopotamab deruxtecanDeanol acetamidobenzoate Debrisoquine; its salts Decitabine; its salts Deferasirox; its salts; its esters; their salts Deferiprone; its salts DefibrotideDegarelix; its salts Dehydroemetine; its salts Delafloxacin; its salts; its esters; their saltsDelamanid; its salts Delandistrogene moxeparvovecDemecarium bromide Denosumab Desferrioxamine; its salts Desflurane Desipramine; its salts Desomorphine; its salts; its esters and ethers; their salts Desvenlafaxine; its salts Deucravacitinib; its saltsDexketoprofen; its salts Dexlansoprazole; its salts Dexmedetomidine; its salts Dexrazoxane; its salts Diacerein; its salts; its esters Diacetylnalorphine; its salts Diampromide; its salts Diazepam and other compounds containing the chemical structure of dihydro-1,4-benzodiazepine substituted to any degree; their saltsDiazoxide Diclofenac; its salts Didanosine; its salts Diethylaminoethylephedrine; its salts Diethyl para-nitrophenyl phosphate Difenoxin; its salts Diflunisal Digitalis, glycosides of; other active principles of digitalis Dihydralazine; its salts Dihydrocodeine; its salts; its esters and ethers; their salts Dihydrocodeinone; its salts Dihydrocodeinone O-carboxymethyloxime; its salts; its esters; their saltsDihydrocodeinone enol acetate; its salts Dihydroergotamine; its salts, simple or complex Dihydroetorphine; its salts Dihydromorphine; its salts; its esters and ethers; their salts 3-(3,4-Dihydroxyphenyl)alanine; its saltsDiltiazem; its salts Dimefline; its salts Dimenoxadole; its salts Dimepheptanol; its salts; its esters and ethers; their salts Dimethyl fumarate when contained in pharmaceutical productsDinutuximab betaDioxaphetyl butyrate; its saltsDiperodon; its saltsDiphenoxylate; its saltsDipipanone; its saltsDiprenorphine; its saltsDiprophylline; its saltsDipyridamoleDiquafosol; its saltsDisopyramide; its saltsDistigmine; its saltsDisulfiramDithienylallylamines; dithienylalkylallylamines; their saltsDobutamine; its salts Docetaxel; its salts Dolutegravir; its salts Domperidone; its salts DonanemabDonepezil; its salts Dopamine; its salts Doravirine; its salts Dornase alfa Dorzagliatin; its saltsDorzolamide; its salts DostarlimabDothiepin; its salts Doxapram; its salts Doxazosin; its salts Doxepin; its salts; its derivatives; their salts Dronedarone; its salts Droperidol Drotrecogin alfa Dulaglutide Duloxetine; its salts Dupilumab Durvalumab Dutasteride Dyflos Econazole; its salts Ecothiopate iodide Ectylurea Eculizumab Edoxaban; its salts Efalizumab Efanesoctocog alfaEfavirenz; its salts Efinaconazole; its salts Elacestrant; its saltsEladocagene exuparvovecElapegademaseElaterin Elbasvir; its salts Eletriptan; its salts Elosulfase alfa Elotuzumab ElranatamabEltrombopag; its salts; its esters; their salts Elvitegravir; its salts Embutramide Emicizumab Empagliflozin; its salts Emtricitabine; its salts Emylcamate Enalapril; its salts Enalaprilat; its salts Encorafenib; its saltsEnfortumab vedotinEnfuvirtide Enoxacin; its salts; its esters Enoxaparin; its salts Enoximone Enrofloxacin; its salts; its esters Ensifentrine; its saltsEntacapone; its salts Entecavir; its salts; its esters; their salts Entrectinib; its salts Enzalutamide; its salts EpcoritamabEplerenone Epoetin beta Eprosartan; its salts Eptifibatide; its salts EptinezumabEquecabtagene autoleucelErdafitinib; its salts Erenumab Eribulin; its salts Erlotinib; its salts Ertugliflozin; its salts Erythrityl tetranitrate Esmolol; its salts Esomeprazole; its salts Etafedrine; its salts Etafenone; its salts Etamivan; its salts Etanercept Etelcalcetide; its salts Ethacrynic acid; its salts Ethambutol; its salts Ethchlorvynol Ethinamate Ethionamide Ethoglucid Ethoheptazine; its salts Ethosuximide; its salts Ethylmorphine; its salts; its esters and ethers; their salts Ethylnoradrenaline; its salts Etidronic acid; its salts; when contained in pharmaceutical products Etilefrine; its salts Etodolac EtofibrateEtomidate; its salts Etonitazene; its salts Etoposide; its esters Etoricoxib; its salts Etorphine; its salts; its esters and ethers; their salts Etoxeridine; its saltsEtranacogene dezaparvovecEtrasimod; its salts; its esters; their saltsEtravirine Etretinate Etryptamine; its salts Everolimus; its salts; its esters; their salts Evocalcet; its salts; its esters; their saltsEvolocumab Exemestane; its salts Exenatide Ezetimibe Famciclovir; its salts Fampridine; its salts FaricimabFebuxostat; its salts; its esters; their salts Felodipine Fenbufen Fencamfamin; its salts Fenclofenac; its salts Fendiline; its salts Fenfluramine; its salts Fenofibrate Fenoprofen; its salts Fenoterol; its salts Fenoxazoline; its salts Fentanyl; its salts Fentiazac; its salts Fenticonazole; its salts Feprazone Fesoterodine; its salts; its esters; their salts Fezolinetant; its saltsFilgotinib; its saltsFilgrastim Finasteride Finerenone; its saltsFingolimod; its salts; its esters; their salts Firocoxib; its salts Fitusiran; its salts Flavoxate; its salts Flecainide; its salts Fleroxacin; its salts; its esters Fluanisone Fluconazole; its salts Flucytosine Fludarabine; its salts Flufenamic acid; its salts; its esters; their salts Flumazenil Flumethrin; its salts Fluorouracil; its derivatives Fluoxetine; its salts Flupenthixol; its salts Fluralaner; its salts Flurbiprofen Fluspirilene Flutamide Fluvastatin Fluvoxamine; its salts Folinic acid; its salts Fondaparinux; its salts Formestane Formoterol; its salts Fosaprepitant; its salts Foscarnet trisodium hexahydrate Fosinopril; its salts Fosnetupitant; its saltsFosphenytoin; its salts Fostamatinib; its saltsFotemustine; its salts FremanezumabFruquintinib; its saltsFrusemide Fulvestrant Fulzerasib; its saltsFurethidine; its salts Futibatinib; its saltsGabapentin; its salts Gadoxetic acid; its salts Galcanezumab Gallamine; its salts; its quaternary compounds Gallium-68; its salts; when contained in pharmaceutical productsGallopamil; its salts Galsulfase Ganciclovir; its salts Ganirelix; its salts GaradacimabGatifloxacin; its salts; its esters Gefitinib; its salts Gemcitabine; its salts Gemfibrozil Gemtuzumab ozogamicin Germanium-68; its salts; when contained in pharmaceutical productsGilteritinib; its saltsGimeracil; its salts Glecaprevir; its salts Glibenclamide Glibornuride GliclazideGlimepiride; its salts Glipizide Gliquidone GlofitamabGlucagon; its salts GlucarpidaseGlutathione; its salts; its derivatives; when contained in products for human parenteral administrationGlutethimide; its salts Glycerol phenylbutyrateGlyceryl trinitrate Glycopyrronium; its salts Glymidine Golimumab Gonadorelin; its salts Goserelin; its salts Gozetotide; its saltsGranisetron; its salts Grazoprevir; its salts Grepafloxacin; its salts; its esters Guanabenz; its salts Guanethidine; its salts Guanfacine; its salts Guanidines, the following—Polymethylene diguanidines; di-para-anisyl-para-phenethylguanidine; their saltsGuselkumabHalofantrine; its saltsHalofuginone; its saltsHaloperidol and other 4-substituted derivatives of N-(3-para-fluorobenzoylpropyl) piperidineHemin; its salts; its esters; their saltsHexamethylmelamineHexapropymateHexobendine; its saltsHuman chondrocytes when contained in advanced therapy products indicated for the repair of symptomatic articular cartilage defectsHuman cytomegalovirus immunoglobulinHydralazine; its saltsHydrazines, the following and their alpha-methyl derivatives—Benzyl hydrazinePhenethyl hydrazinePhenoxyethyl hydrazinetheir salts; their acyl derivatives; their saltsHydrocyanic acid; cyanides, other than ferrocyanides and ferricyanidesHydromorphinol; its salts; its esters and ethers; their saltsHydromorphone; its salts; its esters and ethers; their saltsHydroxycinchoninic acids; derivatives of; their salts; their estersHydroxy-N,N-dimethyltryptamines; their esters and ethers; any salt of any substance falling within this item3-Hydroxy-N-methylmorphinan; its salts; its optical isomers; their salts3-Hydroxymorphinan; its salts; its optical isomers; their salts; their esters and ethers; their salts3-Hydroxy-N-phenacylmorphinan; its salts; its optical isomers; their salts; their esters and ethers; their saltsHydroxypethidine; its salts; its esters and ethers; their saltsHydroxyphenamate Hydroxyurea Hydroxyzine; its salts Ibandronic acid; its salts Ibritumomab tiuxetan Ibrutinib; its salts Ibuprofen; its salts Icatibant; its salts; its esters; their saltsIcosapent ethyl when contained in pharmaceutical products indicated for the reduction of the risk of myocardial infarction, stroke, coronary revascularization, or unstable angina requiring hospitalizationIdarucizumab Idelalisib; its salts Idursulfase Idursulfase betaIfosfamide Iloprost; its salts Imatinib; its salts ImdevimabImidapril; its salts Imiglucerase Imipramine; its salts Imiquimod; its salts Inaticabtagene autoleucelInavolisib; its saltsInclisiran; its saltsIndacaterol; its salts; its esters; their salts Indinavir; its salts Indomethacin; its salts Indoprofen; its salts Indoramin; its salts Infliximab Inosine Inosine pranobex Inotuzumab ozogamicin Insulin Interferons Iodine-131; its salts; when contained in pharmaceutical products Ioflupane Iodine-123; its salts; when contained in pharmaceutical productsIpilimumab Iprindole; its salts Iptacopan; its saltsIrbesartan; its salts Irinotecan; its salts IsatuximabIsavuconazole; its salts; its derivatives; their salts Isoaminile; its salts Isoconazole; its salts Isoetharine; its salts Isoflurane Isomethadone; its salts Isoniazid; its salts; its derivatives; their salts; any compound with any substance falling within this itemIsoprenaline; its salts Isopyrin; its salts Isosorbide; its nitrates Isotretinoin Isoxicam; its salts Isradipine Itraconazole; its salts Ivabradine; its salts Ivosidenib; its saltsIxazomib; its salts Ixekizumab Ketamine; its salts Ketanserin; its salts Ketobemidone; its salts; its esters and ethers; their salts Ketoconazole Ketophenylbutazone Ketoprofen; its salts Ketorolac; its salts; its esters Labetalol; its salts LabuvirtideLacidipine; its salts Lacosamide; its salts Lamivudine; its salts Lamotrigine; its salts LanadelumabLanreotide; its salts Lansoprazole Lanthanum carbonate Lapatinib; its salts Laronidase Laropiprant; its salts Larotrectinib; its salts Latanoprostene bunod; its salts Laudexium; its salts Lazertinib; its saltsLead acetates; compounds of lead with acids from fixed oils LebrikizumabLecanemabLedipasvir; its salts Leflunomide; its salts Lemborexant; its saltsLenacapavir; its saltsLenalidomide; its salts Lenvatinib; its salts Lepirudin; its salts Lercanidipine; its salts Letermovir; its salts; its esters; their salts Letrozole Leuprorelin; its salts Levallorphan; its salts Levetiracetam; its salts Levodropropizine; its salts Levosimendan; its salts Lidoflazine Lignocaine; its salts Linaclotide; its salts Linagliptin; its salts Linezolid; its salts Lipegfilgrastim Liraglutide Lisdexamfetamine; its salts Lisinopril;

its salts Lithium carbonate Lithium sulphate Lixisenatide Lodoxamide tromethamine Lomefloxacin; its salts; its esters Lomustine Lonazolac; its salts Loncastuximab tesirineLopinavir; its salts Loracarbef; its salts Lorcainide; its salts Lorlatinib; its salts Losartan; its salts Lotilaner; its saltsLovastatin when contained in pharmaceutical products Loxapine; its salts Lumefantrine; its salts Lurasidone; its salts Lurbinectedin; its saltsLuspaterceptLutetium-177; its salts; when contained in pharmaceutical productsLutetium (177Lu) oxodotreotide; its saltsLutetium (177Lu) vipivotide tetraxetan; its saltsLysergamide; its salts, simple or complex; its quaternary compoundsLysergic acid; its salts, simple or complex; its quaternary compoundsLysergide; its salts, simple or complex; its quaternary compoundsLysuride; its salts Macitentan; its salts Mangafodipir; its salts Mannityl hexanitrate Mannomustine; its salts Maprotiline; its salts Maralixibat; its saltsMaraviroc; its salts Marbofloxacin; its salts Maribavir; its saltsMarstacimabMavacamten; its saltsMazdutideMazindol Mebezonium iodide Mebutamate Mecamylamine; its salts Meclofenamic acid; its salts Meclofenoxate; its salts Medigoxin Mefenamic acid; its salts; its esters; their salts Mefloquine; its salts Mefruside Melagatran; its salts; its derivatives; their salts Melatonin; its salts; when contained in pharmaceutical products intended to be used for the treatment of insomniaMelitracen; its salts Meloxicam; its salts Memantine; its saltsMephenesin; its esters; their salts Mephenoxalone Mepirizole; its salts Mepivacaine; its salts Mepolizumab Meprobamate alpha-Meprodine; its salts beta-Meprodine; its salts Mercaptopurine; its salts; its derivatives; their salts Mercury, nitrates of; organic compounds of; oxides of; mercuric ammonium chloride; mercuric chloride; mercuric iodide; mercuric oxycyanide; mercuric thiocyanate; potassiomercuric iodidesMeropenem; its saltsMertiatide; its salts; its esters; their saltsMesalazine; its saltsMescaline; its salts; other derivatives of phenethylamine formed by substitution in the aromatic ring; their saltsMesocarb; its salts Metaflumizone; its salts Metaraminol; its salts Metaxalone Metazocine; its salts; its esters and ethers; their salts Metergoline Metformin; its salts Methadone; its salts Methadyl acetate; its salts Methaqualone; its salts Methimazole; its salts Methixene; its salts Methocarbamol Methorphan; its salts; its optical isomers; their salts Methoxsalen Methoxyflurane Methoxyphenamine; its salts Methylaminoheptane; its salts Methyldesorphine; its salts; its esters and ethers; their saltsMethyldihydromorphine; its salts; its esters and ethers; their saltsMethyldopa; its esters; their salts2-Methyl-3-morpholino-1,1-diphenylpropane carboxylic acid; its salts; its esters; their saltsMethylnaltrexone; its saltsMethylpentynol; its derivativesalpha-Methylphenethylamine; beta-methylphenethylamine; alpha-ethylphenethylamine; beta-ethylphenethylamine; their optical isomers; any synthetic compound structurally derived from any of those substances by substitution in the aliphatic part or by ring closure therein (or by both such substitution and such closure) or by substitution in the aromatic ring (with or without substitution at the nitrogen atom), except hydroxyamphetamine, methoxyphenamine, pholedrine and N-substituted derivatives of ephedrine; any salt of any substance falling within this itemMethylphenidate; its salts1-Methyl-4-phenylpiperidine-4-carboxylic acid; its salts; its esters; their saltsMethyprylone Metipranolol; its salts Metoclopramide; its salts Metolazone Metopon; its salts; its esters and ethers; their salts Metoprolol; its salts Metronidazole; its salts; its esters; their saltsMetyrapone; its salts Mexiletine; its salts Mianserin; its salts Mibefradil; its salts Micafungin; its salts; its esters Miconazole; its salts Midodrine; its salts Midostaurin; its salts Mifepristone; its salts; its esters; their salts Migalastat; its saltsMiglitol; its salts Milnacipran; its salts Milrinone; its salts Minoxidil Mirabegron; its salts; its esters; their salts Mirogabalin; its salts; its esters; their saltsMirtazapine; its salts Mitobronitol Mitopodozide; its salts Mitotane Mitoxantrone; its salts Mivacurium; its salts Mizolastine; its salts Mobocertinib; its saltsMoclobemide; its salts Moexipril; its salts Mofebutazone; its salts Molgramostim Molindone; its salts Molnupiravir; its saltsMolybdate (99Mo); its salts; when contained in pharmaceutical productsMomelotinib; its saltsMontelukast; its salts Moracizine; its salts Moramide; its salts; its optical isomers; their salts Moroxydine; its salts Morpheridine; its salts MosunetuzumabMoxifloxacin; its salts Moxonidine; its salts Muromonab-CD3 Mustine and any other N-substituted derivative of di-(2- chloroethyl)amine; their saltsMuzolimine Mycophenolic acid; its salts; its esters Myrophine; its salts Myrtecaine; its salts Nabumetone Nadolol; its salts Nadroparin; its salts Nafarelin; its salts Naftidrofuryl; its salts Nalbuphine; its salts Naldemedine; its saltsNalidixic acid Nalmefene; its salts Nalorphine; its salts Naloxone; its salts Naltrexone; its salts alpha-Naphthylacetic acid; its salts Naproxen; its salts Naratriptan; its salts Natalizumab Nateglinide; its salts; its esters NaxitamabNebivolol; its salts Necitumumab Nedocromil; its salts Nefazodone; its salts Nefopam; its salts Nelfinavir; its salts Neostigmine; its salts Nepafenac; its salts Neratinib; its salts Nesiritide Netarsudil; its saltsNetupitant; its salts Nevirapine; its salts Nicardipine; its salts Nicergoline Niclofolan Nicocodine; its salts Nicotinamide mononucleotide when contained as an active ingredient in products for human parenteral administrationNicotinic acid and its salts when contained in pharmaceutical products the recommended daily dose of which contains more than 200 mg of nicotinic acidNifedipine Nifenazone Niflumic acid; its salts Nifuratel; its saltsNifuroxazide; its saltsNilotinib; its salts Nilvadipine Nimesulide; its salts Nimodipine Nintedanib; its salts Niraparib; its salts Nirmatrelvir; its saltsNirsevimabNisoldipine Nitrendipine Nitric oxide when contained in pharmaceutical productsNitrofural; its saltsNitrofurantoin; its saltsNitromethaqualone; its saltsNitrous oxide when contained in pharmaceutical productsNitroxoline; its saltsNivolumab Nomifensine; its salts Noracymethadol; its salts Noramidopyrine methanesulphonate; its salts Norcodeine; its salts; its esters and ethers; their salts Norfloxacin; its salts; its esters Normethadone; its salts Normorphine; its salts; its esters and ethers; their salts Norpipanone; its salts Nortriptyline; its salts Nusinersen; its salts Obinutuzumab; its antibody drug conjugates Oclacitinib; its saltsOcrelizumabOcriplasmin Octreotide; its salts Odevixibat; its salts; its esters; their saltsOfatumumabOfloxacin; its salts; its esters Olanzapine; its salts Olaparib; its salts Olaratumab Olmesartan; its salts; its esters; their salts Olodaterol; its salts Olsalazine; its salts Omalizumab Ombitasvir; its salts Omega-3 fatty acids; their salts; their esters; when contained in pharmaceutical products intended to be used for the treatment of hypertriglyceridaemiaOmeprazole; its salts Omidenepag; its salts; its esters; their saltsOmoconazole; its salts Onasemnogene abeparvovecOndansetron; its salts Opipramol; its salts; its derivatives; their salts Opium Orciprenaline; its salts Orgotein Orlistat; its salts Orphenadrine; its salts Orthocaine; its salts Oseltamivir; its salts Osimertinib; its salts Oteracil; its salts Ouabain Oxalic acid; its salts other than quadroxalates Oxaliplatin; its salts Oxanamide Oxcarbazepine; its salts Oxethazaine; its salts Oxiconazole; its salts Oxolamine; its salts Oxprenolol; its salts Oxycinchoninic acid; its derivatives; their salts; their esters Oxycodone; its salts; its esters and ethers; their salts Oxyfedrine; its salts Oxymorphone; its salts; its esters and ethers; their salts Oxypertine Oxyphenbutazone Oxytocins Ozanimod; its saltsPaclitaxel Palbociclib; its salts Paliperidone; its salts Palivizumab Palonosetron; its salts Pamidronate; its salts Pancuronium; its salts Panitumumab Panobinostat; its salts Pantethine; its salts Pantoprazole; its salts Paraldehyde Paramethadione Parecoxib; its salts Pargyline; its salts Paricalcitol; its salts; its esters; their salts Paritaprevir; its salts Paroxetine; its salts Pasireotide; its salts Pazopanib; its salts Pefloxacin; its salts; its esters Pegaptanib; its salts PegaspargasePegfilgrastim Pegunigalsidase alfa Pegvisomant; its salts Pembrolizumab Pemetrexed; its salts; its esters; their salts Pemigatinib; its saltsPemirolast; its salts Pemoline; its salts Pempidine; its salts Penbutolol; its salts Penciclovir; its salts Penicillamine; its salts Pentaerythritol tetranitrate Pentamidine; its salts Pentazocine; its salts Pentolinium; its salts Pentoxifylline; its saltsPerampanel PerflubutanePergolide; its salts Perindoprilat; its salts; its esters; their salts Pertechnetate (99mTc); its salts; when contained in pharmaceutical productsPertuzumab Pharmaceutical products for human parenteral administration containing the following or their salts, as active ingredients, except in mixture with insulin—Acetic acidAcetylcholineAcetylcysteineAdenosineAdrenalineAmbroxolAmino acidsAminophyllineAnti-D (rho) immunoglobulinsAntihistamine substancesBetiatideBicisateButetamateCaffeineCarnitineCations, the following, except in preparations containing any substance to which the Antibiotics Ordinance (Cap. 137) applies—CalciumChromiumCopperIronMagnesiumManganesePotassiumSeleniumSodium, except sodium chloride 0.9%ZincCholineCimetidineCiticolineDeoxycholic acidDextromethorphanDicycloverineDifenidolDisofeninEphedrineExametazimeFish oilFluoresceinGalliumGelatinGlucosamineGlucoseGlycerolGlyceryl trinitrateGuaifenesinHeparinHyaluronic acidHyaluronidaseHydroxyethyl starchHyoscineIcodextrinIndigo carmineIndocyanine greenIodine norcholesterolIsosorbideLactic acidLecithinLignocaineMannitolMebrofeninMedronic acidMesnaMethoxyphenamineMethylene blueMethylephedrineNoradrenalineOlive oilOmeprazoleOxidronatePapaverineParacetamolPatent blue VPentetic acidPhenolPhenylephrineProcaineProtamineRanitidineRheniumSodium chloride 0.9%Sodium pyrophosphateSodium tetradecyl sulfateSodium thiosulfateSorbitolSoya oilStonefish antivenomSuccimerTerbutalineTetrakis copper tetrafluoroborateTetrofosminThalliumTinTriglyceridesTuberculinVitaminsWaterXantinol nicotinatePhenacemide Phenacetin Phenadoxone; its salts Phenaglycodol Phenampromide; its salts Phenazocine; its salts; its esters and ethers; their salts Phenazopyridine; its saltsPhenbutrazate Phencyclidine; its salts Phenetidylphenacetin Phenformin; its salts Phenindione Phenols (any member of the series of phenols of which the first member is phenol and of which the molecular composition varies from member to member by 1 atom of carbon and 2 atoms of hydrogen) except in substances containing less than 60%, weight in weight, of phenols; compounds of phenol with a metal, except in substances containing less than the equivalent of 60%, weight in weight, of phenolsPhenomorphan; its salts; its esters and ethers; their saltsPhenoperidine; its salts; its esters and ethers; their saltsPhenothiazine; its salts; its derivatives (except dimethoxanate); their salts (except salts of dimethoxanate); any compound with any substance falling within this itemPhenoxybenzamine; its saltsPhenprenazonePhenprobamatePhentolamine; its saltsPhenylbutazone; its salts2-Phenylcinchoninic acid; 2-salicylcinchoninic acid; their salts; their esters5-Phenylhydantoin; its alkyl and aryl derivatives; their salts4-Phenylpiperidine-4-carboxylic acid ethyl ester; its saltsPholcodine; its salts; its esters and ethers; their saltsPhospholipid fraction; when contained in pharmaceutical products intended to be used as pulmonary surfactant for the treatment of respiratory distress syndromePibrentasvir; its salts Picric acid Picrotoxin Pimecrolimus Piminodine; its salts Pimobendan; its salts Pioglitazone; its salts Pipecuronium; its salts Pipemidic acid Pipobroman Piracetam; its saltsPirfenidone; its salts Piritramide; its salts Piromidic acid; its salts Piroxicam Pirprofen; its salts Pirtobrutinib; its saltsPitavastatin; its salts; its esters; their saltsPitolisant; its saltsPituitary gland, the active principles of, other than corticotrophins, oxytocins and vasopressinsPizotifen; its salts Plerixafor; its salts Podophyllum resin Polatuzumab vedotin Polymethylenebistrimethylammonium salts Pomalidomide; its salts Ponatinib; its salts Ponesimod; its saltsPoractant alfa Porfimer; its salts Posaconazole; its salts; its esters; their salts Pralidoxime; its salts Pralsetinib; its saltsPramipexole; its salts Pramoxine; its salts Prasterone; its salts; when contained in pharmaceutical products Prasugrel; its salts Pravastatin; its salts; its esters Prazosin; its salts Pregabalin; its salts Pretomanid; its saltsPridinol; its salts Primaquine; its salts Primidone Prindolol; its salts ProbenecidProbucol Procainamide; its salts Procarbazine; its salts Procaterol; its salts Procyclidine; its salts alpha-Prodine; its salts beta-Prodine; its salts Proglumetacin; its salts Proguanil; its salts Proheptazine; its salts Promoxolane Propafenone; its salts Propanidid Propiverine; its salts Propofol Propoxur; its salts Propoxyphene; its salts; its optical isomers; their salts Propranolol; its salts; its derivatives; their salts Propylhexedrine; its salts Propylthiouracil; its salts Proquazone Prostaglandins, the following and their derivatives—AlprostadilBimatoprostDinoprostDinoprostone Epoprostenol Latanoprost Misoprostol Travoprost Unoprostone their salts; their estersProthionamide Prothipendyl; its salts Protirelin; its salts Protriptyline; its salts; its derivatives; their salts Prucalopride; its salts Prulifloxacin; its salts; its esters; their salts Pseudoephedrine; its salts Pyrazinamide Pyricarbate (Pyridinolcarbamate) Pyridostigmine; its salts Pyrimethamine Pyriprole; its salts Pyrithyldione Quetiapine; its salts Quinagolide; its salts Quinapril; its salts Quinethazone Quinidine; its salts Quinine; its salts; its derivatives; their salts Quizartinib; its saltsRabeprazole; its salts Racecadotril; its salts Ractopamine; its salts Radium-223; its salts; when contained in pharmaceutical productsRaloxifene; its salts Raltegravir; its salts Raltitrexed; its salts Ramipril; its salts Ramucirumab Ranibizumab Ranolazine; its salts Rasagiline; its salts Rasburicase; its salts RavulizumabReboxetine; its salts Recombinant human erythropoietin Regadenoson; its salts Regorafenib; its salts Remdesivir; its saltsRemifentanil; its salts Remoxipride; its salts Repaglinide; its salts; its esters Repotrectinib; its saltsReproterol; its salts Rescinnamine Reteplase Retigabine; its salts Revefenacin; its saltsReviparin; its salts Ribavirin; its salts Ribociclib; its salts Rilmenidine; its salts Rilpivirine; its salts Riluzole; its salts Rimegepant; its saltsRimiterol; its salts Rimonabant; its salts Riociguat; its salts Ripretinib; its saltsRisankizumabRisdiplam; its saltsRisedronic acid; its salts Risperidone Ritlecitinib; its saltsRitodrine; its salts Ritonavir; its salts Rituximab Rivaroxaban; its salts Rivastigmine; its salts Rizatriptan; its salts Rocuronium; its salts Rofecoxib; its salts Roflumilast; its salts Romiplostim Romosozumab Ropeginterferon alfa-2bRopinirole; its salts Ropivacaine; its salts Rosiglitazone; its salts Rosoxacin; its salts Rosuvastatin; its salts Rotigotine; its salts Roxadustat; its saltsRozanolixizumabRufinamide; its salts Rurioctocog alfa pegolRuxolitinib; its salts Sacituzumab govitecanSacubitril; its salts Safinamide; its saltsSalbutamol; its salts Salmeterol; its salts Saquinavir; its salts Sarilumab SatralizumabSavin, oil of Savolitinib; its saltsSaxagliptin; its salts Sebelipase alfaSecukinumab Selexipag; its salts Selinexor; its saltsSelpercatinib; its saltsSelumetinib; its saltsSemaglutide Sermorelin; its salts SerplulimabSertaconazole; its salts Sertindole; its salts Sertraline; its salts Sevelamer; its salts SevofluraneSibutramine; its salts; any compound containing the chemical structure of 1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan-1-amine substituted to any degree or without substitution; its saltsSildenafil; its salts; any compound containing the chemical structure of 5-(2-ethoxyphenyl)-1-methyl-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-7(6H)-one substituted to any degree or without substitution; its saltsSilodosin; its saltsSiltuximabSimeprevir; its saltsSimvastatin SintilimabSiponimod; its salts; its esters; their saltsSirolimus; its salts Sitagliptin; its salts SocazolimabSodium aurothiomalate Sodium cromoglycate Sodium nitroprusside Sodium zirconium cyclosilicate Sofosbuvir; its salts Solifenacin; its salts; its esters; their salts Solriamfetol; its saltsSomapacitanSomatostatin SomatrogonSorafenib; its salts Sotalol; its salts SotaterceptSotorasib; its saltsSparfloxacin; its salts; its esters Sparteine; its salts SpesolimabSpinosad Spironolactone Stavudine; its salts Stiripentol; its saltsStreptokinase Strontium ranelate Strophanthus, glycosides of Styramate Sucroferric oxyhydroxide Sugammadex; its salts; its esters; their salts Sulconazole; its salts Sulindac Sulphinpyrazone Sulphonal; alkyl sulphonals Sulpiride Sultopride Sumatriptan; its salts Sunitinib; its salts Suprarenal gland, the active principles of; their salts; their derivatives; their saltsSurufatinib; its saltsSutoprofen; its saltsSuxamethonium; its saltsSyrosingopineTacrine; its saltsTacrolimusTadalafil; its salts; any compound containing the chemical structure of 6-(Benzo[1,3]dioxol-5-yl)-2,3,6,7,12,12a-hexahydropyrazino [1’,2’:1,6]pyrido[3,4-b]indole-1,4-dione substituted to any degree or without substitution; its salts Tafamidis; its salts TafasitamabTafluprost TafolecimabTagraxofuspTalazoparib; its salts Taletrectinib; its saltsTalquetamabTamoxifen; its salts Tapentadol; its salts TarlatamabTazarotene; its salts Tazemetostat; its saltsTeclistamabTegaserod; its salts Telbivudine; its salts Telmisartan; its salts Temozolomide; its salts Temsirolimus; its salts; its esters Tenapanor; its saltsTenecteplase; its salts Teniposide Tenofovir; its salts; its derivatives; their salts Tenoxicam Tepotinib; its saltsTeprotumumabTerazosin; its salts Terbinafine; its salts; except when contained in preparations for external application only with no more than 1% of Terbinafine and not to be administered as a single application and when labelled only for the treatment of tinea pedis or tinea cruris, or bothTerbutaline; its salts Terconazole; its salts Teriflunomide; its salts Teriparatide; its salts Terodiline; its salts Tertatolol; its salts Tetrabenazine; its salts Tetracosactide; its salts TezepelumabThalidomide; its salts Thallium, salts of Theofibrate Theophylline; its salts Thiacetazone Thiocarlide; its salts Thioctic acid; its salts; its derivatives; when contained in pharmaceutical productsThiotepa Thymosin alpha 1 Thyroid gland, the active principles of; their salts Thyrotropin alfa Tiagabine; its salts; its esters; their salts Tianeptine; its salts; its esters; their salts Tiapride; its salts Ticagrelor; its salts; its esters; their salts Ticlopidine; its salts TildrakizumabTiletamine; its salts Tilidate; its salts Tiludronic acid; its salts Timolol; its salts Tinidazole; its salts Tinoridine; its salts Tinzaparin; its salts Tioconazole; its salts Tiotropium; its salts Tipiracil; its salts; when contained in pharmaceutical productsTiratricol; its salts Tirofiban; its salts TirzepatideTisagenlecleucel TislelizumabTisotumab vedotinTixagevimabTizanidine; its salts Tocainide; its salts Tocilizumab Todralazine; its salts Tofacitinib; its salts Tofenacin; its salts Tolazamide Tolbutamide Tolcapone; its salts Tolfenamic acid; its salts Tolmetin; its salts Tolperisone; its salts Tolterodine; its salts Tolvaptan para-Tolylmethylcarbinol nicotinic acid ester Topiramate; its salts Topotecan; its salts Torasemide ToripalimabTrabectedin; its salts; its esters Tramadol; its salts Trametinib; its salts Trandolapril; its salts Tranexamic acid Tranylcypromine; its salts Trastuzumab; its antibody drug conjugates Trazodone; its salts TremelimumabTreosulfan; its saltsTreprostinil; its salts; its esters; their saltsTretamine; its salts Tretinoin Tretoquinol; its salts Triamterene; its salts Triaziquone Tribromoethyl alcohol 2,2,2-Trichloroethyl alcohol, esters of; their salts Trientine; its salts; when contained in pharmaceutical productsTrifarotene; its salts; its esters; their saltsTrifluridine; its salts Trilostane Trimeperidine; its salts Trimetaphan; its salts Trimetazidine; its salts Trimethadione Trimethoprim Trimetozine Trimetrexate; its salts Trimipramine; its salts Trioxsalen Triptorelin; its salts Tromantadine; its salts Tropisetron; its salts Trospium chlorideTrovafloxacin; its salts; its derivatives; their salts Tucatinib; its saltsTulobuterol; its salts Tybamate Umeclidinium; its salts Upadacitinib; its saltsUrapidil; its salts Urethane Urokinase Ustekinumab Valaciclovir; its salts Valdecoxib; its salts Valganciclovir; its salts Valnoctamide Valproic acid; its salts; its esters Valsartan; its salts Vandetanib; its salts Vardenafil; its salts; any compound containing the chemical structure of 2-(2-ethoxyphenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one substituted to any degree or without substitution; its saltsVarenicline; its salts Vasopressins Vecuronium; its salts Vedolizumab Velmanase alfaVelpatasvir; its salts Vemurafenib; its salts Venetoclax; its salts Venlafaxine; its salts Veralipride; its salts Verapamil; its salts Vericiguat; its saltsVernakalant; its salts Verteporfin; its salts Vidarabine; its salts Vigabatrin Vilanterol; its salts Vildagliptin; its salts Viloxazine; its salts Vindesine; its salts Vinorelbine; its salts Vismodegib; its salts Vitamin A and its esters when contained in pharmaceutical products the recommended daily dose of which contains not less than 10 000 international units of vitamin AVitamin D and its salts when contained in pharmaceutical products the recommended daily dose of which contains more than 1 000 international units of vitamin DVitamin K and its salts when contained in pharmaceutical products, except products with recommended daily dose of 120 mcg or less of vitamin K1 or K2 or its saltsVonoprazan; its saltsVorasidenib; its saltsVoriconazole; its salts Vortioxetine; its salts VosoritideVoxilaprevir; its salts Vutrisiran; its saltsWarfarin; its salts Xamoterol; its salts Xylazine; its salts Zafirlukast Zalcitabine; its salts Zaleplon; its salts Zanamivir; its salts Zanubrutinib; its saltsZidovudine Zimelidine; its salts Zipeprol; its salts Ziprasidone; its salts Zofenopril; its salts Zolazepam; its salts ZolbetuximabZoledronic acid; its salts Zolmitriptan; its salts Zolpidem; its salts Zomepirac; its salts Zongertinib; its saltsZopiclone Zoxazolamine; its salts (L.N. 34 of 2015; L.N. 67 of 2015; L.N. 100 of 2015; L.N. 193 of 2015; L.N. 235 of 2015; L.N. 40 of 2016; L.N. 51 of 2016; L.N. 83 of 2016; L.N. 119 of 2016; L.N. 172 of 2016; L.N. 11 of 2017; L.N. 38 of 2017; L.N. 119 of 2017; L.N. 140 of 2017; L.N. 167 of 2017; L.N. 10 of 2018; L.N. 42 of 2018; L.N. 80 of 2018; L.N. 136 of 2018; L.N. 191 of 2018; L.N. 210 of 2018; L.N. 228 of 2018; L.N. 3 of 2019; L.N. 10 of 2019; L.N. 30 of 2019; L.N. 145 of 2019; L.N. 184 of 2019; L.N. 14 of 2020; L.N. 41 of 2020; L.N. 126 of 2020; E.R. 5 of 2020; L.N. 212 of 2020; L.N. 252 of 2020; L.N. 104 of 2021; L.N. 218 of 2021; L.N. 1 of 2022; L.N. 19 of 2022; L.N. 33 of 2022; L.N. 122 of 2022; L.N. 194 of 2022; L.N. 232 of 2022; L.N. 10 of 2023; L.N. 108 of 2023; L.N. 138 of 2023; L.N. 9 of 2024; L.N. 73 of 2024; L.N. 105 of 2024; L.N. 135 of 2024; L.N. 177 of 2024; L.N. 5 of 2025; L.N. 38 of 2025; L.N. 116 of 2025; L.N. 161 of 2025; L.N. 211 of 2025; L.N. 13 of 2026; L.N. 42 of 2026) Division B Alkali fluorides other than those specified in Part 2 of this ListBarium, salts of, except barium sulphatealpha-Chlorohydrin (3-chloro-1,2-Propanediol)Dinitronaphthols; dinitrophenols; dinitrothymolsHexachlorophane, the following—(a) medicinal products for human use containing more than 0.1% hexachlorophane;(b) preparations for animal use—(i) aerosols the contents of the container of which contain more than 0.1% hexachlorophane;(ii) soaps and shampoos containing more than 2% hexachlorophane;(iii) other medicinal products (except those for oral administration to sheep or cattle for liver fluke disease) containing more than 0.75% hexachlorophanemeta-Nitrophenol; ortho-nitrophenol; para-nitrophenolPhosmetPhosphorus, yellowSulphuric acid, except substances containing not more than 70%, weight in weight, of sulphuric acid Part 2 Division A Antihistamine substances not included in Part 1 of this List; their salts; their compounds with any other substanceAspirin; its salts; when contained in pharmaceutical productsBenzocaine when contained in condomsalpha-ChloraloseClotrimazole; its salts; when contained in pharmaceutical products labelled only for the treatment of tinea pedis or tinea cruris, or bothEthenzamide; its saltsLoratadine; its salts; when contained in pharmaceutical products labelled for the relief of the symptoms of allergic rhinitis onlyNicotine when contained in (a) chewing gum or lozenges, intended to be used in nicotine replacement therapy and containing not more than 4 mg of Nicotine per piece; or (b) patches for external application, intended to be used in nicotine replacement therapyParacetamol; its salts; when contained in pharmaceutical productsPharmaceutical products retailed in the form as supplied by the manufacturer, containing a poison included in Division A of Part 1 of this List, where the proportion of the poison does not exceed the equivalent of—(a) 0.01% by weight of arsenic trioxide, cantharidin, cocaine, coniine, ecgonine, hydrocyanic acid, strychnine, alkaloids of aconite, alkaloids of coca or alkaloids of gelsemium;(b) 2%, weight in volume, of mercurochrome when contained in solutions for external use only; and(c) 0.1% by weight in the case of other poisons,except pharmaceutical products containing any poison—(d) included in Schedule 3; or (E.R. 5 of 2020)(e) in the following list—Acetyldihydrocodeine; its saltsAlkaloids of belladonna; their saltsAlkaloids of ephedra; their saltsAtropine; its saltsBambuterol; its saltsBenzydamine; its saltsButropium; its saltsCodeine; its saltsDextromethorphan; its saltsDiclofenac; its saltsDihydrocodeine; its saltsEthylmorphine; its saltsFenoterol; its saltsFormoterol; its saltsHomatropine; its saltsHyoscine; its saltsHyoscyamine; its saltsIpratropium; its saltsMethylaminoheptane; its saltsMorphine; its saltsNicocodine; its saltsNicotine (except when contained in (a) chewing gum or lozenges, intended to be used in nicotine replacement therapy and containing not more than 4 mg of Nicotine per piece; or (b) patches for external application, intended to be used in nicotine replacement therapy); any compound containing the chemical structure of 3-(1-methylpyrrolidin-2-yl)pyridine substituted to any degree or without substitutionNorcodeine; its saltsOrciprenaline; its saltsPapaverine; its saltsPhenylpropanolamine; its saltsPholcodine; its saltsProcaterol; its saltsSalmeterol; its saltsTerbutaline; its saltsTretoquinol; its saltsPhenazone; its saltsPhenols as defined in Part 1 of this List in substances containing less than 60%, weight in weight, of phenols; compounds of phenol with a metal in substances containing less than the equivalent of 60%, weight in weight, of phenolsPropyphenazone; its saltsSalicylamide; its salts; when contained in pharmaceutical productsSteroid compounds with androgenic or oestrogenic or progestational activity; their esters; when contained in a preparation intended to be taken orally for contraceptive purposes only and each dose of the preparation contains not more than the following—0.15 mg of Desogestrel;3.00 mg of Drospirenone;0.05 mg of Ethinyloestradiol;0.10 mg of Gestodene;0.25 mg of Levonorgestrel;2.50 mg of Lynoestrenol;0.05 mg of Mestranol;1.00 mg of Norethisterone;0.25 mg of Norgestimate; and0.50 mg of NorgestrelTerbinafine; its salts; when contained in preparations for external application only with no more than 1% of Terbinafine and not to be administered as a single application and when labelled only for the treatment of tinea pedis or tinea cruris, or both(L.N. 234 of 2015; L.N. 235 of 2015; L.N. 194 of 2022; L.N. 105 of 2024; L.N. 177 of 2024)Division B Ammoniagamma-Benzene hexachloride (1,2,3,4,5,6-hexachlorocyclo-hexane)Diamines, the following; their salts—Phenylene diamines; toluene diamines; other alkylated-benzene diaminesFormaldehydeFormic acidHydrochloric acidHydrofluoric acid; alkali fluorides; alkali metal bifluorides; ammonium bifluorides; sodium silicofluorideMetallic oxalatesNitric acidNitrobenzenePhosphoric acidPotassium hydroxideProducts retailed in the form as supplied by the manufacturer, containing a poison included in Division B of Part 1 of this List, where the proportion of such poison does not exceed the equivalent of 0.1%Sodium hydroxideSodium nitrite(Schedule 10 added 2 of 2015 s. 71. E.R. 3 of 2015)