Pharmacy and Poisons Act

Section 1. Short title Section This Act may be cited as the Pharmacy and Poisons Act.

Section 2. Interpretation Section 2(1)(a) diagnosis, prevention, monitoring, treatment or alleviation of disease; Section 2(1)(a)(i) diagnosis, prevention, monitoring, treatment or alleviation of disease; Section 2(1)(a)(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; Section 2(1)(a)(iii) investigation, replacement, modification or support of the anatomy or of a physiological process; Section 2(1)(a)(iv) supporting or sustaining life; Section 2(1)(a)(v) control of conception; Section 2(1)(a)(vi) disinfection of medical devices; or Section 2(1)(a)(vii) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and Section 2(1)(b) which does not achieve its primary intended action in or on the human or animal body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means; Section 2(1)(a) treating, preventing or alleviating disease or symptoms of disease; Section 2(1)(b) diagnozing disease or ascertaining the existence, degree or extent of a physiological condition; or Section 2(1)(c) preventing or interfering with th...

Section 3. Establishment of Pharmacy and Poisons Board Section 3(1)(a) be a registered pharmacist of good standing with a degree in pharmacy; and Section 3(1)(a)(i) be a registered pharmacist of good standing with a degree in pharmacy; and Section 3(1)(a)(ii) have at least ten years' experience in the pharmaceutical sector; Section 3(1)(b) the Director of pharmaceutical services; Section 3(1)(c) the Principal Secretary in the ministry for the time being responsible for matters relating to finance or his or her representative; Section 3(1)(d) two persons representing the pharmacy training institutions, of which one shall be a pharmacist and one shall be a pharmaceutical technologist; Section 3(1)(e) one person shall be a pharmacist representing institutions of higher learning; Section 3(1)(e)(i) one person shall be a pharmacist representing institutions of higher learning; Section 3(1)(e)(ii) one person shall be a pharmaceutical technologist representing mid-level colleges; and Section 3(1)(e)(iii) one person shall be an enrolled pharmaceutical technologist with expertise in community pharmacy nominated by the Kenya Pharmaceutical Association; Section 3(1)(f) the Chief Executive Off...

Section 4. Proceedings of Board Section 4(1) The Board shall meet at such times and places as it deems necessary or expedient for the transaction of its business. Section 4(2) The Chairperson shall preside at all meetings of the Board, and in his absence for any reason at a meeting the Board shall choose one of its number who shall act in his stead during such absence. Section 4(3) The Chairperson at any meeting of the Board shall, in addition to his deliberative vote as a member of the Board, have a casting vote. Section 4(4) The quorum of the Board shall be five, of whom three shall be pharmacists. Section 4(5) The Chief Executive Officer shall cause details of all business conducted or transacted at meetings of the Board to be entered regularly in a minute book kept for the purpose under his direction. The minutes of the proceedings of each meeting shall be submitted at the meeting following, and, if then passed as correct, shall be confirmed by the signature of the Chairperson and shall, when so confirmed, be prima facie evidence in all courts and places that the minutes are an accurate record of the proceedings so recorded. Section 4(6) The powers of the Board shall not be aff...

Section 5. The Registrar Section 5(1) There shall be a Registrar of the Board who shall be the Chief Executive Officer of the Board competitively recruited and appointed by the Board upon such terms and conditions of service as shall be determined by the Board upon the advice of the Salaries and Remuneration Commission. Section 5(2) The Registrar shall perform such duties and exercise such powers, in addition to those required under the provisions of this Act to be performed and exercised, as the Board may from time to time direct. Section 5(3) The Registrar shall be responsible to the Board for the day to day management of its affairs. Section 5(4)(a) be a Kenyan citizen; Section 5(4)(b) hold at least a pharmacy degree and is registered to practice pharmacy in Kenya; Section 5(4)(c) belong to the professional body of registered pharmacists; Section 5(4)(d) have at least fifteen years of pharmacy practice experience; Section 5(4)(e) have served in a senior management position for a period of at least ten years; and Section 5(4)(f) meet the requirements of Chapter Six of the Constitution. Section 5(5) The Registrar shall hold office for a term of four years, but shall be eligible fo...

Section 3A. Powers of the Board Section formulate guidelines for regulating the manufacture, import and export, distribution, sale and use of medical products;

Section 3B. Functions of the Board Section 3B(1) The Board shall be responsible for the regulation of health products, technologies and the profession of pharmacy. Section 3B(2)(a) advise the national and county governments in all matters relating to the safety, packaging and distribution of medicines; Section 3B(2)(b) ensure that all medicinal products manufactured in, imported into or exported from the country conform to prescribed standards of quality safety and efficacy; Section 3B(2)(c) ensure that the personnel, premises and practices employed in the manufacture, storage, marketing, distribution and sale of medicinal substances comply with the defined codes of practice and other prescribed requirements; Section 3B(2)(d) enforce the prescribed standards of quality, safety and efficacy of all medicinal substances manufactured, imported into or exported out of the country; Section 3B(2)(e) grant or revoke licenses for the manufacture, importation, exportation, distribution and sale of medicinal substances; Section 3B(2)(f) maintain a register of all authorized medicinal substances; Section 3B(2)(g) publish, at least once in every three months, lists of authorized or registered m...

Section 6. Register of pharmacists Section 6(1) The registrar shall keep a register of pharmacists and specialist pharmacists in the prescribed form. Section 6(2) The registrar shall keep a Roll of pharmaceutical technologists in the prescribed form. Section 6(3) The register kept under this section shall be automated for the purposes of sharing information under the National Single Window System established under section 3 of the National Electronic Single Window System Act. [Act No. 2 of 2002 , Sch., Act No. 5 of 2019 , Sch., Act No. 25 of 2022 , Sch.]

Section 7. Application for registration as pharmacist Section 7(1) Every application by a person to be registered as a pharmacist shall be made in writing in the form prescribed and shall be addressed to the registrar. Section 7(2) Every application by a person to be entered in the Roll of pharmaceutical technologists shall be made in the prescribed form and shall be addressed to the registrar. [Act No. 2 of 2002 , Sch.]

Section 8. Qualifications for registration Section 8(1)(a) is at the commencement of this Act already registered as a pharmacist under the provisions of the Pharmacy and Poisons Act (Repealed); or Section 8(1)(b) satisfies the Board that he holds at least a bachelor of pharmacy degree (whether of Kenya or of some other country) which the Board considers acceptable, shall, Section 8(2) Any person who satisfies the Board that he holds a diploma in pharmacy from any college recognised by the Board in Kenya shall, subject to this Act, be entitled to have his or her name entered in the register. [Act No. 3 of 1968 , s. 3, Act No. 11 of 1993 , Sch., Act No. 2 of 2002 , Sch., Act No. 5 of 2019 , Sch.]

Section 9. Certificate of registration Section 9(1) Upon the registration of a pharmacist, the registrar shall, on payment of the prescribed fee, issue a certificate of registration in the prescribed form: Provided that fee shall be payable if the pharmacist was, at the commencement of this Act, already registered under the Pharmacy and Poisons Ordinance (Repealed). Section 9(2) The Registrar shall issue to every Pharmaceutical technologist whose name is entered in the Roll, a certificate of enrolment in the prescribed form, upon payment of the prescribed fee. [Act No. 2 of 2002 , Sch.]

Section 10. Corrections to the register Section 10(1)(a) to delete from the register the name of any registered pharmacist who has died; Section 10(1)(b) to delete from the register any entry which the Board direct him to delete therefrom as being in their opinion an entry which was procured by fraud; Section 10(1)(c) to correct in accordance with the Board’s directions any entry in the register which the Board direct him to correct as being in their opinion an incorrect entry; and Section 10(1)(d) to make from time to time any necessary alterations in the register, including such deletions, alterations and insertions as he may by virtue of this Act be required to make. Section 10(2) If the registrar sends by post to any registered pharmacist a registered letter addressed to him at his address on the register inquiring whether he has ceased to practice as a pharmacist or has changed his address and receives no reply to the letter within six months from the date of posting it he may delete the name of that person from the register: Provided that the Board may, on the application of the person whose name has been so deleted and on payment by him of such fee as may be prescribed, dire...

Section 11. Publication of details of registered pharmacists Section 11(1) Whenever a name is added to or deleted from the register for any cause the registrar shall without undue delay publish in the Gazette the fact of such the addition or deletion and the reason therefor, together with the name and address of the person concerned. Section 11(2) The registrar shall, as soon as conveniently may be after the first day of January in every year, publish in the Gazette a list of the names, qualifications and addresses of all registered pharmacists.

Section 12. Professional misconduct Section 12(1)(a) a person applying to have his name registered; or Section 12(1)(b) a registered pharmacist or any person employed by him in the carrying on of his business; or Section 12(1)(c) a person whose name has been deleted from the register or any person employed by him as aforesaid, Section 12(1)(i) in a case falling within paragraph (a) of this subsection, direct that the applicant’s name shall not be registered, or shall not be registered until the Board otherwise directs; Section 12(1)(ii) in a case falling within paragraph (b) of this subsection, direct the registrar to delete the name of the registered pharmacist from the register; Section 12(1)(iii) in a case falling within paragraph (c) of this subsection, direct that the name removed from the register shall not be restored thereto, or shall not be restored thereto until the Board otherwise directs, Section 12(2) Where the name of any person has been deleted from the register in pursuance of a direction under paragraph (ii) of subsection (1) of this section, the Board may, either of its own motion or on the application of that person, direct the registrar to restore the name to th...

Section 13. Restriction on directions by Board Section 13(1) Where an act or omission which under subsection (1) of section 12 may be made the ground of a direction by the Board involving the cesser or restriction of the right of a person to have his name registered is an act or omission on the part of an employee of that person, the Board shall not give any such direction unless proof is given to its satisfaction of some one or more of the facts specified in the next subsection and the Board is of the opinion that, having regard to the facts so proved, the said person ought to be regarded as responsible for the act or omission. Section 13(2)(a) that the act or omission in question was instigated or connived at by the said person; Section 13(2)(b) that the person or any employee of his had been guilty at some time within twelve months before the date on which the act or omission in question took place of a similar act or omission and that the person had, or reasonably ought to have had, knowledge of that previous act or omission; Section 13(2)(c) if the act or omission in question was a continuing act or omission, that the person had, or reasonably ought to have had, knowledge of t...

Section 14. Appeal against direction, etc Section 14(1) A person aggrieved by a direction of the Board under section 12 of this Act or by the refusal of an application made under subsection (2) of that section may at any time within one month from the date on which notice of the direction or, as the case may be, of the refusal is given to him appeal to the Supreme Court against the direction or refusal, and the Board may appear as respondent in any such appeal. Section 14(2) The Supreme Court may on any such appeal make such order as it thinks fit in the matter and any order of the Supreme Court on any such appeal shall be final. Section 14(3) It shall be the duty of the registrar to make such alterations in the register as are necessary to give effect to any such order as aforesaid.

Section 15. Time of operation of direction for deletion of name Section A direction under paragraph (ii) of subsection (1) of section 12 of this Act shall not take effect until the expiration of one month from the giving of notice of the direction as required by subsection (3) of that section or, where an appeal to the Supreme Court is brought against the direction, until the appeal is determined or withdrawn.

Section 16. Registration or restoration of name where appeal dismissed Section If the Supreme Court has dismissed an appeal against a direction under subsection (1) of section 12 of this Act that a name shall be deleted from the register or shall not, until the Board otherwise directs, be registered or restored to the register, a direction by the Board authorizing the registration or restoration of the name shall not take effect unless it is approved by the Cabinet Secretary. [Act No. 25 of 2015 , Sch.]

Section 17. Deletion of name from register for conduct outside Kenya Section If by reason of a conviction or of professional misconduct the name of a pharmacist registered in Kenya (whether before or after such conviction or misconduct) is in any other country removed, deleted or struck from the register of pharmacists (by whatever name or style designated) of such country, or if by any order or other process such pharmacist is in any such country disentitled to practise as a pharmacist (by whatever name or style designated), the Board may direct the registrar to delete the name of the pharmacist from the register, but without prejudice to the provisions of subsection (2) of section 12 of this Act. [Act No. 13 of 1980 , Sch.]

Section 18. Surrender of certificate on deletion of name Section 18(1) Every person whose name is deleted from the register for any reason shall forthwith surrender his certificate of registration to the Registrar for cancellation. Section 18(2) Any person refusing or failing to comply with the provisions of this section shall be guilty of an offence and shall be liable on conviction, to a fine not exceeding ten thousand shillings, or to imprisonment for a term not exceeding one year, or to both. [Act No. 2 of 2002 , Sch.]

Section 19. General restrictions as to unregistered persons Section 19(1)(a) carry on, either on his own behalf, or on behalf of another, the business of a pharmacist; Section 19(1)(b) in the course of any trade or business, prepare, mix, compound or dispense any drug except under the immediate supervision of a registered pharmacist; Section 19(1)(c) assume, take, exhibit or in any way make use of any title, emblem or description reasonably calculated to suggest that he is registered as a pharmacist. Section 19(2) Any person who contravenes subsection (1) shall be guilty of an offence and liable to a fine not exceeding thirty thousand shillings or to imprisonment for a term not exceeding three years or to both. Section 19(3) For the purpose of paragraph (c) of subsection (1) of this section, the use of any of the words "pharmacist", "druggist", "chemist", "medical" or any similar word or combination of words in any language shall be deemed to be reasonably calculated to suggest that the owner of the business and the person having control of the business on the premises are registered pharmacists. Section 19(4) Nothing in this section shall extend to or interfere with the supply of...

Section 20. Pharmacist to display name and registration certificate Section 20(1) It shall not be lawful for any person to carry on the business of a pharmacist unless the name and certificate of registration of the person having control of the business are conspicuously exhibited in the premises in which the business is carried on. Section 20(1A) No person shall carry on the business of a pharmaceutical technologist unless the name and certificate of enrolment of the person having control of the business are conspicuously exhibited in the premises in which the business is carried on. Section 20(1B) No person shall operate the business of a pharmacist or pharmaceutical technologist without the presence of a registered pharmacist or enrolled pharmaceutical technologist in the premises where such business is being carried out. Section 20(2) Any person contravening the provisions of this section shall be guilty of an offence and shall be liable on conviction to a fine not exceeding one million shillings, or to imprisonment for a term not exceeding one year, or to both. [Act No. 7 of 1990 , Act No. 9 of 2000 , s. 79, Act No. 2 of 2002 , Sch., Act No. 5 of 2019 , Sch.]

Section 21. Bodies corporate Section 21(1)(a) a copy of the certificate of incorporation of the body corporate is lodged with the Board; Section 21(1)(b) such business is under the management of a superintendent who is a registered pharmacist and a member of the board of directors of the body corporate, and who is not acting in a similar capacity for any other body corporate; Section 21(1)(c) in each set of premises where the business is carried on, the business, so far as concerns the retail sale of drugs, is carried on by the superintendent, or, subject to the directions of the superintendent, by a manager or assistant who is a registered pharmacist; Section 21(1)(d) in each set of premises where the business is carried on, the name and certificate of registration of the person in control of the business is conspicuously displayed. Section 21(2) Any emblem, description or title which may be used by a registered pharmacist, may be used by a body corporate lawfully carrying on the business of the pharmacist.

Section 22. Carrying on of business by personal representatives Section 22(1) Notwithstanding anything in the foregoing provisions of this Part, if a registered pharmacist dies, or becomes of unsound mind or is adjudged bankrupt or enters into an arrangement with his creditors, his representatives may, with the permission of the Board and subject to such directions and conditions as the Board may deem fit to impose, carry on the business, and it shall not be necessary for such representatives to be registered provided that such business is continued only under the personal management and control of a registered pharmacist and for such period not exceeding five years as the Board may decide, and that the provisions of subsection (1) of section 20 of this Act are complied with. Section 22(2) Any title, emblem or description which may lawfully have been used by the registered pharmacist may continue to be used by his representatives as long as they are authorized by the Board to carry on the business. Section 22(3) For the purposes of this section an arrangement with creditors means a composition or scheme made in pursuance of the law for the time being in force relating to bankruptcy...

Section 23. Premises to be registered Section 23(1) It shall not be lawful for any person to carry on the business of a pharmacist except in premises registered in accordance with this section. Section 23(1A) No person shall carry on the business of a pharmaceutical technologist except in premises registered in accordance with this section. Section 23(2) Application for registration of premises shall be made to the Board in the prescribed form, and shall be accompanied by such fee, not exceeding one hundred shillings, in respect of the registration of any set of premises, as may be prescribed. Section 23(3) The registration of any premises under this section shall become void upon the expiration of thirty days from the date of any change in the ownership of the business carried on therein. Section 23(4) The Board may, for good and sufficient reason to be stated in writing, refuse to register or may cause to be deleted from the register any premises which in the Board’s opinion are or have become unsuitable for the carrying on therein of the business of a pharmacist. Section 23(5) It shall be the duty of the registrar to keep a register in the form prescribed of all premises registe...

Section 24. Authorized seller of poisons Section Any person lawfully carrying on the business of a pharmacist in accordance with the provisions of this Part shall be an authorized seller of poisons.

Section 12A. Enquiries and Disciplinary Committee Section 12A(1) The Board shall establish an Enquiries and Disciplinary Committee which shall enquire into any matter arising under section 12 of this Act. Section 12A(2)(a) issue the pharmacist or pharmaceutical technologist with a letter of admonishment; Section 12A(2)(b) impose a fine as may be prescribed in regulations; Section 12A(2)(c) suspend the registration or enrolment of the pharmacist or pharmaceutical technologist for a specified period not exceeding five years; or Section 12A(2)(d) remove the name of the pharmacist or pharmaceutical technologist from the Register as may be appropriate. Section 12A(3) The Board may order a pharmacist or pharmaceutical technologist to reimburse costs and expenses incurred in connection with a disciplinary hearing and such costs shall be a civil debt recoverable summarily by the Board. [Act No. 5 of 2019 , Sch.]

Section 23A. Power to close premises Section 23A(1) Any premises having been deleted from the register of premises by the Board or any premises which in the Board's opinion have become unsuitable for the carrying on of the business of a pharmacist or pharmaceutical technologist shall be closed. Section 23A(2) The Board shall give the person in charge of the premises at least fourteen days' notice of the intended closure under subsection (1) and the reasons thereof in writing. Section 23A(3) If at the expiry of the period under subsection (2), the Board is not satisfied that the improvements required have been made, an authorized officer shall order closure of the premises [Act No. 5 of 2019 , Sch.]

Section 9A. Practising licence Section 9A(1) The Registrar shall issue, in accordance with rules made under this Act, a practising licence authorizing registered pharmacists or enrolled pharmaceutical technologists to practice as registered pharmacists or enrolled pharmaceutical technologists. Section 9A(2) Every practising licence shall expire at the end of the practising year in which it was issued. Section 9A(3) The practising year shall be from 1st January to 31st December. Section 9A(4) Any registered pharmacist or enrolled pharmaceutical technologist who practices without a valid practising licence in line with subsection (1) commits an act of professional misconduct. [Act No. 5 of 2019 , Sch.]

Section 9B. Application for practising licence Section A person wishing to be issued with a practising licence under section 9A shall make an application to the Registrar in the prescribed form and such application shall be accompanied by the prescribed fee. [Act No. 5 of 2019 , Sch.]

Section 9C. Issue of practising licence Section 9C(1)(a) is registered under section 6 of this Act; Section 9C(1)(b) has undertaken continuous professional development in the preceding year as prescribed by the Board; and Section 9C(1)(c) meets such other requirements as may be prescribed. Section 9C(2)(a) engages in, conducts or carries on the dispensing, manufacture, compounding of any drugs or medicines, or offers any form of pharmaceutical care or pharmaceutical services within Kenya; or Section 9C(2)(b) advertises or represents himself or herself by a title, sign, display, declaration, or other item to be a pharmacist or pharmaceutical technologist. Section 9C(3) For purposes of this Act, it shall be a requirement for every practising registered pharmacist and enrolled pharmaceutical technologist, practising in their private capacity, government, faith based institutions, non-governmental organizations, training institutions, research organizations or any other institution, to have a valid practising licence. [Act No. 5 of 2019 , Sch.]

Section 9D. Refusal to issue or renew a license Section The Board may deny or refuse to issue or renew a license under this Act if it determines after due process, that the applicant has failed to comply with the requirements of this Act or its rules. [Act No. 5 of 2019 , Sch.]

Section 9E. Renewal, cancellation and suspension of license Section 9E(1) A registered pharmacist or enrolled pharmaceutical technologist issued with a license under this Act may apply for renewal of the license in the prescribed form at least thirty days before the date of expiry thereof. Section 9E(2) A registered pharmacist or an enrolled pharmaceutical technologist who fails to renew a license within the prescribed period shall, when applying for a renewal, be required to pay such late application fee as shall be prescribed. [Act No. 5 of 2019 , Sch.]

Section 9F. Continuous professional development Section For purposes of maintaining a level of competence in his or her ongoing practice, every registered pharmacist and enrolled pharmaceutical technologist shall undertake appropriate Continuous Professional Development as prescribed by the Board. [Act No. 5 of 2019 , Sch.]

Section 25. Preparation of Poisons List Section 25(1) The Board shall prepare and submit to the Cabinet Secretary for his approval a list of the substances which are to be treated as poisons for the purposes of this Act. Section 25(2)(a) Part I of the list shall consist of those poisons which, subject to this Act, are not to be sold except by authorized sellers of poisons and by licensed wholesale dealers and dealers in mining, agricultural or horticultural accessories; Section 25(2)(b) Part II of the list shall consist of those poisons which, subject to the provisions of this Act, are not to be sold except by persons entitled to sell Part I poisons and by persons licensed under the provisions of section 32 of this Act. Section 25(3) In determining the distribution of poisons as between Part I and Part II of the list, regard shall be had to the desirability of restricting Part II to articles which are in common use, or likely to come into common use, which it is reasonably necessary to include therein if the public are to have adequate facilities for obtaining them. Section 25(4) The Cabinet Secretary may, by order, confirm the list with or without modification, and may, after cons...

Section 26. Possession of Part I poisons Section 26(1)(a) a wholesale dealer licensed under section 27 of this Act, for the purposes of the licence and on the premises so licensed; Section 26(1)(b) an authorized seller of poisons, on premises registered under section 23 of this Act; Section 26(1)(c) a person licensed under section 28 of this Act to sell poisons for mining, agricultural or horticultural purposes, for the purposes of the licence and on premises so licensed; Section 26(1)(d) any person, institution or department, to whom a Part I poison has been lawfully sold in accordance with section 29 of this Act, for the purpose for which such sale was made; Section 26(1)(e) any person for whom the poison has been lawfully supplied or dispensed by a duly qualified medical practitioner, dentist, or veterinary surgeon, or by a hospital, dispensary or similar institution under the provisions of section 31 of this Act; Section 26(1)(f) subject to any conditions which may be prescribed, a representative of a person engaged in the business of selling and supplying pharmaceutical goods, for the purpose of giving free samples of such goods, in the course of such business, to persons who...

Section 27. Wholesale dealer’s licence Section 27(1) If the Board is satisfied that it is in the public interest that a licence to deal as a wholesale dealer in poisons should be issued or renewed it may, on application being made to the Board in writing on such form as may be prescribed, and on payment of the prescribed fee, issue to the applicant a licence in the form prescribed, or, as the case may be, renew such licence. Section 27(2) The Board may refuse to issue or renew, or may revoke, a licence under this section, for any good and sufficient reason relating either to the applicant or licensee, or to the premises in which the business is, or is proposed to be, carried on, and an appeal shall lie from such refusal or revocation to the Cabinet Secretary, whose decision thereon shall be final. Section 27(3) A separate licence under this section shall be required in respect of each set of premises in which the business of the licensee is carried on. Section 27(4) No licence shall be issued or renewed under this section unless the person applying for or holding such licence is or has a registered pharmacist in control of the distribution of the poisons and the registered pharmaci...

Section 28. Licence to deal in poisons for mining agricultural or horticultural purposes Section 28(1) A person carrying on a regular business in mining, agricultural or horticultural accessories may apply to the Board in writing on the prescribed form for a licence to deal in poisons and any such licence, if granted, shall authorize the licensee to sell only the poisons specified therein, to persons who require them for a trade or business of mining, agriculture or horticulture. Section 28(2) A separate licence under this section shall be required in respect of each set of premises in which the business of the licensee is carried on. Section 28(3) If the Board is satisfied that it is in the public interest that a licence under this section should be issued or renewed it may, upon payment of the prescribed fee, issue to the applicant a licence in the prescribed form, or, as the case may be, renew such licence: Provided that the Board may refuse to issue or renew, or may revoke, a licence for any good and sufficient reason relating either to the applicant or licensee or to the premises in which the business is, or is proposed to be, carried on, and in case of such refusal or revocat...

Section 29. Power to sell Part I poisons Section 29(1)(a) a person lawfully carrying on the business of a wholesale dealer in poisons in Kenya; Section 29(1)(b) a person lawfully carrying on the business of a pharmacist in Kenya; Section 29(1)(c) a person lawfully carrying on the business of a dealer in poisons for mining, agricultural or horticultural purposes in Kenya; Section 29(1)(d) a duly qualified medical practitioner, dentist or veterinary surgeon for purposes of medical, dental or veterinary treatment respectively; Section 29(1)(e) the Government or a local authority or its institutions for public purposes; Section 29(1)(f) a hospital, dispensary or similar institution or a person or institution concerned with scientific education or research, whether within or outside Kenya, where such hospital, dispensary, institution or person has been approved in that behalf by an order, whether general or special, of the Cabinet Secretary: Section 29(2)(a) in possession of the prescription of a duly qualified medical practitioner, dentist or veterinary surgeon, in accordance with such prescription; or Section 29(2)(b) in possession of a written certificate to the effect that he may pr...

Section 30. Poisons Book Section 30(1)(a) he has made or caused to be made an entry in a book kept for the purpose, to be called a Poisons Book, indicating in the form prescribed the date of the sale, the name and address of the purchaser and of the person, if any, by whom the certificate required under paragraph (b) of subsection 29(2) was given, the name and quantity of poison sold, and the purpose for which it is stated by the purchaser to be required; and Section 30(1)(b) the purchaser has affixed his signature to the aforesaid entry. Section 30(2)(a) before the sale is completed the seller shall obtain an order in writing signed by the purchaser, showing the purchaser’s name, address and occupation, the name and quantity of poison to be purchased and the purpose for which it is required: Provided that where a person represents that he urgently requires a poison for the purpose of his trade, business or profession and satisfies the seller that by reason of some emergency he is unable before delivery to furnish the order in writing, the seller may forthwith deliver the poison to the purchaser who shall within twenty-four hours of the sale furnish the seller with such written ord...

Section 31. Supply and dispensing of Part I poisons by doctors, hospitals, etc. Section 31(1)(a) the poison shall be distinctly labelled with the name and address of the person by whom it is supplied or dispensed; Section 31(1)(b) the date on which the poison was supplied or dispensed; Section 31(1)(b)(i) the date on which the poison was supplied or dispensed; Section 31(1)(b)(ii) the ingredients and the quantity supplied; Section 31(1)(b)(iii) the name and address of the person to whom the poison was supplied; Section 31(1)(b)(iv) the name and address of the person by whom the prescription was given, Section 31(2) An authorized seller of poisons may supply a Part I poison prescribed and dispensed by himself, and in every case in which he supplies a Part I poison on prescription (whether the prescription has been drawn up by himself or not) shall enter the particulars in his Prescription Book in accordance with this section, but shall not in respect of such supply be required to make any entry in the Poisons Book in accordance with section 30 of this Act. Section 31(3) Any person to whom subsection (1) of this section apply who supplies or dispenses any Part I poison otherwise than...

Section 32. Licence to sell Part II poisons Section 32(1) Every person who, not being otherwise empowered so to do, desires to sell Part II poisons may make application for a licence in writing in the manner prescribed to the Board or a person appointed by it in writing for the purpose. Section 32(2) If the Board or the person appointed by it is satisfied that it is necessary for a licence under this section to be issued or renewed in order that the public may have adequate facilities for obtaining Part II poisons and that the applicant is a fit and proper person to sell the poisons, and that the premises in which this business is to be carried on are suitable, he may, on payment of the fee prescribed, issue or renew the licence. Section 32(3) A licence granted under this section may be made subject to such conditions and limitations as the Board or the person appointed by it may think fit to impose. Section 32(4) Every licence granted under this section shall be in the prescribed form and shall expire on the 31st December of the year in which it is granted. Section 32(5) The Board or the person appointed by it may refuse to issue or renew a licence, or may revoke the licence of an...

Section 33. Power to sell Part II poisons Section 33(1)(a) a person licensed under section 27 to deal as a wholesale dealer in poisons, to the persons and others to whom he is entitled under section 29 to sell Part I poisons, and to persons licensed under section 32 of this Act in accordance with their licences; Section 33(1)(b) an authorized seller of poisons; Section 33(1)(c) a person licensed under section 28 to sell poisons for mining, agricultural or horticultural purposes, in accordance with such licence; Section 33(1)(d) a person licensed under section 32 to sell Part II poisons, in accordance with that licence. Section 33(2) Nothing in subsection (1) shall make it illegal for a person to sell or resell to a wholesale dealer licensed under section 27 , or to an authorised seller of poisons, stocks of Part II poisons which are found to be surplus to requirements, or for a person whose licence has been revoked or has expired to sell the poisons in his possession at the time of revocation or expiry, if the sale takes place within three months after the time of revocation or expiry or such longer time as the Board may allow. Section 33(3) A person who sell a Part II poison excep...

Section 34. Labelling of containers Section 34(1)(a) with the name of the poison; and Section 34(1)(b) in the case of a preparation which contains a poison as one of the ingredients thereof, with the prescribed particulars as to the proportion which the poison contained in the preparation bears to the total ingredients; and Section 34(1)(c) with the word "Poison" or other prescribed indication of the character of the article; and Section 34(1)(d) if supplied on sale (other than wholesale), with the name of the seller and the address of the premises on which it is sold; and Section 34(1)(e) if supplied otherwise than on sale, with the name and address of the supplier: Section 34(2) The provisions of paragraphs (a), (b) and (c) of subsection (1) shall not apply in respect of a poison made up and supplied for the use of a particular person being a poison prescribed by reference to the needs of that person. Section 34(3) Any person who commits an offence under this section shall be liable to a fine not exceeding twenty thousand shillings, or to imprisonment for a period not exceeding one year or to both. [Act No. 2 of 2002 , Sch.]

Section 35. Prohibition on sale of poisons in automatic machines Section A person exposing or causing to be exposed for sale any poison in or by means of an automatic machine shall be guilty of an offence and liable to a fine not exceeding twenty thousand shillings or to imprisonment for a period not exceeding one year or to both. [Act No. 2 of 2002 , Sch.]

Section 25A. Clinical trials Section 25A(1) A pharmaceutical product shall not be used for clinical trial unless an approval is granted by the Board with the approval of the relevant ethics body. Section 25A(2) Any person who intends to commence a clinical trial on a pharmaceutical product shall make an application to the Board in the prescribed form and the application shall be accompanied by the study protocol in the prescribed format and the prescribed fee. Section 25A(3) The study protocol submitted under subsection (2) shall include a post- trial access program to ensure access of investigational medicinal substances by participants in a trial before grant of marketing authorization by the Board. Section 25A(4) The Board shall prescribe guidelines for evaluation of applications made under subsection (2) to be implemented for accelerated evaluations during emergency situations, epidemics and outbreaks. Section 25A(5) A person granted an approval under section 25A (1) shall put up a robust quality assurance system to ensure that the clinical trial is carried out so as to ensure the integrity of data generated, the safety and well-being of study participants. Section 25A(6) The B...

Section 35A. Licence to manufacture medicinal substances Section 35A(1) No person shall manufacture any medicinal substance unless he has been granted a manufacturing licence by the Board. Section 35A(2) Each manufacturing licence shall expire on the 31st December of every year and the renewal thereof shall be subject to compliance with conditions prescribed by the Board. Section 35A(3) No person shall manufacture any medicinal substance for sale unless he has applied for and obtained a licence from the Board in respect of each substance intended to be manufactured. Section 35A(4) Any person who intends to manufacture a medicinal substance shall make an application in the prescribed form for the licensing of the premises; and the application shall be accompanied by the prescribed fee. Section 35A(5) The Board or any person authorized in writing by the Board shall have power to enter and sample any medicinal substance under production in any manufacturing premises and certify that the method of manufacture approved by the Board is being followed. [Act No. 12 of 1992 , s. 3, Act No. 20 of 2017 , s. 34(a).]

Section 35B. Compliance with good manufacturing practice Section Every person who is granted a manufacturing licence under section 35A shall comply with the good manufacturing practices prescribed by the Board. [Act No. 12 of 1992 , s. 3.]

Section 35C. Interpretation of Part Section In this Part, unless the context otherwise requires— "Director" means the Director of the National Quality Control Laboratory appointed under section 35H ; "Laboratory" means the National Quality Control Laboratory established under section 35D . [Act No. 12 of 1992 , s. 3.]

Section 35D. Establishment of the National Drug Quality Control Laboratory Section the examination and testing of drugs and any material or substance from or with which and the manner in which drugs may be manufactured, processed or treated and ensuring the quality control of drugs and medicinal substances;