The Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) Regulations, of 2021
This section lists sample-related topics: types of samples, port of entry samples, registration of samples, and inspection of samples.
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- The Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) Regulations, of 2021
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Statute overview
About this statute
This section lists sample-related topics: types of samples, port of entry samples, registration of samples, and inspection of samples. This provision is titled “Post marketing surveillance samples.” This section is titled “Commercial and non-regulated samples” and relates to sample submission and testing. This section concerns the issuance of a certificate of analysis and sits under rules about subcontracting testing and identifying/selecting testing laboratories. Section 21 is titled “Receipt and review of results” and is placed in Part VI on disposal of samples and waste.
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Provisions of The Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) Regulations, of 2021
Showing 90 of 90
- 5 Verify source ↗
Section 5
AI-assisted research summary: This section lists sample-related topics: types of samples, port of entry samples, registration of samples, and inspection of samples.
5. PART III SAMPLE CATEGORIES Types of samples. Port of entry samples. Registration of samples. Inspection of samples.
Part
PART III
- 10 Verify source ↗
Post marketing surveillance samples
AI-assisted research summary: This provision is titled “Post marketing surveillance samples.”
10. Post marketing surveillance samples. - 12 Verify source ↗
Commercial and non-regulated samples
AI-assisted research summary: This section is titled “Commercial and non-regulated samples” and relates to sample submission and testing.
12. Commercial and non-regulated samples. PART IV 1 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) SAMPLE SUBMISSION AND TESTING - 6 Verify source ↗
There shall be the following types of samples to
AI-assisted research summary: This provision lists the types of samples that may be analysed at TMDA laboratories.
6. There shall be the following types of samples to be analysed at TMDA laboratories- (a) port of entry samples; (b) registration samples; (c) inspection samples; 9 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Port of entry samples (d) post marketing surveillance samples; (e) controlled drugs samples; (f) commercial samples; and (g) any other samples as it may be required. - 7 Verify source ↗
(1) All batches of samples of anti-malarials, anti
AI-assisted research summary: Certain medicine and product samples must be collected from ports of entry and tested for conformity or quality; suspicious batches get laboratory testing, and failed batches may be re-exported or disposed of.
7.-(1) All batches of samples of anti-malarials, anti- tuberculosis, anti-retrovirals and antibiotics shall be collected from ports of entry and tested for conformity to specifications as part of the quality assurance programme. (2) Notwithstanding subregulation (1) in case of suspicious batches of samples, the same shall be collected by inspectors at ports of entry for testing in the laboratories. (3) Subject to subregulation (1), all batches of samples of rapid test kits for malaria and Human Immunodeficiency Virus, condoms, intrauterine devices and pregnancy test kits shall be sampled from ports of entry and subjected to quality testing. (4) Without prejudice to the generality of regulation 8 any other sample as it may deem fit may be subjected to testing as part of quality assurance programme of regulated products from time to time. (5) All batches of samples which will fail laboratory testing shall be re-exported back to the country of origin or disposed as it may deem fit and as provided for in the disposal regulations. fails to conform with the provisions of (6) Notwithstanding this regulation, in case three different batches of the same product testing requirements, the entire product shall be condemned and either re-exported back to the country of origin or disposed as deemed necessary and as provided for in the disposal regulations. laboratory Registration of samples - 8 Verify source ↗
(1) Samples submitted to support marketing
AI-assisted research summary: Samples submitted for marketing authorisation applications may be analysed, and samples for registration must use both compendial and non-compendial methods as appropriate.
8.-(1) Samples submitted to support marketing authorisation applications may be analysed as it may deem necessary (2) Subject to subregulation (1) both compendial and non-compendial methods, as appropriate, shall be used when testing samples for registration. 10 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Inspection of samples Post marketing surveillance samples Controlled drugs samples - 9 Verify source ↗
(1) In case of any suspicious products, samples
AI-assisted research summary: Suspicious products and samples may be collected from routine inspections, screened with minilab kits or scanners, and, where appropriate, confirmatory testing is done. Batches that fail laboratory testing must be recalled and disposed of under the recall and disposal regulations.
9.-(1) In case of any suspicious products, samples the market during routine will be collected from inspections, and shall be screened using minilab kits, scanners or any other followed by confirmatory testing, where appropriate. instruments (2) All batches of products which will fail laboratory testing, shall be recalled from the market and disposed as specified in the recall and disposal regulations. - 10 Verify source ↗
(1) Samples collected from the market through
AI-assisted research summary: Market surveillance samples must be screened and tested, and failed batches must be recalled and disposed of; if three batches of the same product fail, the whole product must be condemned, recalled, and disposed of.
10.-(1) Samples collected from the market through post marketing surveillance programme shall be screened using minilab kits, scanners or any other devices and tested to to confirm in specifications. their conformity laboratories the (2) Subject to subregulation (1), in case one batch fails laboratory testing, such batch shall be recalled and disposed off as specified in the recall and disposal regulations. (3) Subject to subregulation (2), in case three batches of the same product fails laboratory testing, the entire product shall be condemned, recalled from the market and disposed. - 11 Verify source ↗
(1) Samples of narcotic and psychotropic
AI-assisted research summary: Samples of narcotic and psychotropic substances must be kept in a separate register, tested like other regulated products, and reconciled at each stage of analysis through final disposal.
11.-(1) Samples of narcotic and psychotropic substances shall be recorded in a separate register and tested like other regulated products. (2) Subject to subregulation (1), each unit shall be reconciled at each stage of analysis including its final disposal. Commercial and non- regulated samples - 12 Verify source ↗
(1) Subject to these Regulations, the TMDA
AI-assisted research summary: TMDA laboratories may accept and test listed categories of products and samples, and they must test the parameters listed for those samples.
12.-(1) Subject to these Regulations, the TMDA laboratories may accept and test the following categories of commercial and non-regulated products: (a) samples of all regulated products; (b) soil samples; (c) human biological specimens originating from health facilities including hospitals, health centres and dispensaries; 11 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) (d) animal biological specimens drawn from different species and originating from animal and other clinics, veterinary facilities; ambulatory services (e) samples from research institutes; (f) samples of herbal medicines originating from traditional healers and other sources; (g) environmental samples suspected to contaminate water and food chain; (h) hospital supplies samples to include aprons, bed sheets, medical equipment and others; and (i) other related samples or specimens as the Authority may consider necessary. (2) Without prejudice to subregulation (1), the parameters to be tested for the samples specified in subregulation (1), shall be the following: (a) drug residues; (b) heavy metals such as mercury, lead, arsenic, cyanide, cadmium, copper, chromium and selenium; (c) pH; (d) sterility (e) endotoxins; (f) microbial contamination; (g) mycotoxins; (h) residual as solvents trichloroethanes, such toluene, benzene, chloroform, chlorobenzene, dichloroethanes, dichloromethanes, hexane, dichloroethenes, formamide, tetrahydrofuran, pyridine, ethyleneglycol, 1,4-dioxane, acid, butanols, ethanol, ethylacetate, formic acid, methanol, acetonitrile, acetone, carbontetrachloride, isooctane and isopropyl ether; acetic (i) related substances; (j) inorganic impurities; (k) uniformity of content; (l) dissolution; 12 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) (m) disintegration; (n) assay; (o) identification; (p) osmolarity; (q) viscosity; (r) veterinary drug residues; (s) pesticide residues; (t) drug metabolites; (u) alcohol content; (v) sensitivity and specificity; and (w) any other parameter as may be considered necessary. PART IV SAMPLE SUBMISSION AND TESTING Submission of samples
Part
PART IV
- 17 Verify source ↗
Section 17
AI-assisted research summary: This section concerns the issuance of a certificate of analysis and sits under rules about subcontracting testing and identifying/selecting testing laboratories.
17. Issuance of certificate of analysis. PART V SUB-CONTRACTING TESTING Identifying and selecting testing laboratories. - 13 Verify source ↗
(1) Samples submitted for testing in all TMDA
AI-assisted research summary: Samples sent to TMDA laboratories must include the required request form, samples in original containers, and analysis fees; they must also have at least three months of shelf life.
13.-(1) Samples submitted for testing in all TMDA laboratories shall be accompanied by the following: (a) dully filled test request form clearly indicating the parameters to be tested as prescribed in Form No. 1 set out in the First Schedule to these Regulations; (b) physical samples in their original containers; (c) analysis fees as prescribed in the Fees and Charges Regulations. (2) Subject to subregulation (1)(b), the minimum number of units to be submitted for testing depending on the nature of the medicinal product and medical devices or diagnostics is as prescribed under the Second and Third Schedule, respectively. (3) Notwithstanding regulation, samples submitted for testing shall have a remaining shelf life of not less than three months. this (4) Without prejudice to subregulation (3), the Authority may request samples which are close to expiry for investigation purposes, and such samples shall be drawn from manufacturer’s retained sample room. 13 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Receipt of samples Handling of samples Testing of samples Issuance of certificate of analysis (5) Subject to subregulation (4), the close to expiry date shall be as specified in the request note issued by the Authority.
Part
PART V
- 21 Verify source ↗
Receipt and review of results
AI-assisted research summary: Section 21 is titled “Receipt and review of results” and is placed in Part VI on disposal of samples and waste.
21. Receipt and review of results. PART VI DISPOSAL OF SAMPLES AND WASTE - 18 Verify source ↗
(1) The Authority may identify and select third
AI-assisted research summary: The Authority may choose third-party laboratories for sample testing when needed, must keep a register of subcontracting laboratories, and must get the customer’s written consent before subcontracting samples for analysis.
18.-(1) The Authority may identify and select third party laboratories for testing of samples when need arise. (2) Subject to subregulation (1), in selecting such laboratories, the following criteria shall be taken into account: (a) accreditation status; (b) prequalification status; (c) laboratories which had complied with prior audit conducted by the authority; (d) desk review of laboratories which complies with quality management system requirements; and (e) the cost of analysis of the sub-contracted laboratories. (3) Subject to subregulation (1), the Authority shall maintain a register of sub-contracting laboratories which shall be reviewed from time to time. (4) Subject to subregulation (1), the Authority shall obtain a written consent from the customer before sub- contracting samples for analysis. - 19 Verify source ↗
(1) The Authority shall enter into written
AI-assisted research summary: The Authority must make a written agreement with the sub-contracting laboratories before sending samples for analysis, and it must specify the contract terms and format.
19.-(1) The Authority shall enter into written agreement with the sub-contracting laboratories before sending samples for analysis. (2) Subject to subregulation (1), the terms and conditions of the contract including the format to be used shall be specified by the Authority. - 20 Verify source ↗
(1) When sending samples
AI-assisted research summary: When samples are sent to sub-contracting laboratories for analysis, the Authority must take all measures to keep them intact and in acceptable condition, and it must pay the transportation cost.
20.-(1) When sending samples the sub- contracting laboratories for analysis, the Authority shall take all measures to ensure that the samples remain intact and in acceptable integrity. to 15 Contract signing Sending samples for testing Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) (2) Subject to subregulation (1), the cost of sample transportation shall be borne by the Authority. Receipt and review of results - 21 Verify source ↗
(1) The Authority shall review results obtained
AI-assisted research summary: The Authority must review results from sub-contracting laboratories, and if the review is satisfactory, issue a certificate of analysis.
21.-(1) The Authority shall review results obtained from the sub-contracting laboratories for any discrepancies and if all parameters have been tested as agreed. (2) Upon satisfaction of review under subregulation (1), the Authority shall issue a certificate of analysis specified under the Fifth and Sixth Schedule to these Regulations. the Disposal of samples analysed Cap. 191 Disposal of biological, radioactive and chemical wastes (3) Subject to subregulation (1), the Authority shall be accountable for results obtained from the sub-contacting laboratories. PART VI DISPOSAL OF SAMPLES AND WASTE
Part
PART VI
- 23 Verify source ↗
Disposal of biological, radioactive and chemical wastes
AI-assisted research summary: Section 23 concerns the disposal of biological, radioactive, and chemical wastes.
23. Disposal of biological, radioactive and chemical wastes. - 24 Verify source ↗
Disposal of controlled drug samples
AI-assisted research summary: This section is titled “Disposal of controlled drug samples.”
24. Disposal of controlled drug samples. PART VII LABORATORY RESULTS DISPUTES HANDLING - 22 Verify source ↗
(1) All samples analysed
AI-assisted research summary: Samples analysed in TMDA laboratories must be disposed of under the disposal regulations; the Authority may also donate tested samples that meet specifications to public institutions and health facilities.
22.-(1) All samples analysed in all TMDA laboratories shall be disposed in accordance with the disposal regulations. (2) Subject to subregulation (1), as part of disposal, the Authority may donate samples, which have been tested and found to comply with specifications to public institutions and health facilities. (3) Disposal of samples under these Regulations, shall comply with the Environmental Management Act. - 23 Verify source ↗
(1) All hazardous substances and agents
AI-assisted research summary: The Authority must identify, label, and store hazardous substances and wastes before disposal, and laboratory staff must take precautions when handling them.
23.-(1) All hazardous substances and agents including biological, radioactive and chemical wastes shall be identified, labelled as such and properly stored by the Authority before disposal (2) Subject to subregulation (1), in handling such wastes, precautionary measures shall be taken by the laboratory staff to avoid any cross-contamination that might lead to health hazards. (3) Subject to subregulation (1), all biological wastes shall be deactivated before disposal. (4) Subject to subregulation (1), the Authority may enter into agreement with companies approved by the 16 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) institution responsible for environmental management to dispose wastes. (5) Subject to subregulation (1), the contracted disposal company shall, upon finalised disposal of wastes, issue proof of disposal to the Authority. Disposal of controlled drug samples - 24 Verify source ↗
(1) Notwithstanding
AI-assisted research summary: Controlled drug sample disposal records must be kept so they can be audited, and the records must be retained for one year after the samples expire.
24.-(1) Notwithstanding the provisions of regulation 23, disposal of controlled drug samples shall be reconciled by taking into account the following factors: (a) number of samples received; (b) number of units subjected into analysis; (c) number of units and empties remaining after analysis; and (d) number of units disposed. (2) Subject to subregulation (1), all records related to disposal of controlled drug samples shall be maintained to allow for audit by any relevant authorities. (3) Records referred to in subregulation (1), shall be retained for a period of one year post expiry of controlled drug samples. PART VII LABORATORY RESULTS DISPUTES HANDLING Handling of disputed laboratory results
Part
PART VII
- 25 Verify source ↗
Handling of disputed laboratory results
AI-assisted research summary: This section is titled “Handling of disputed laboratory results” under Part VIII on the Laboratory Technical Committee.
25. Handling of disputed laboratory results. PART VIII LABORATORY TECHNICAL COMMITTEE - 25 Verify source ↗
(1) Where there is any objection of laboratory
AI-assisted research summary: If a customer objects to laboratory results, they must give written grounds within 14 days. The Authority must review the objection and may lead a further testing dispute process.
25.-(1) Where there is any objection of laboratory results issued by the Authority, the customer shall submit grounds thereof in a written notice within 14 days from the date of receipt of the results. (2) The Authority shall, upon receipt of objection from the customer, review the results and conduct a thorough investigation of the method used for analysis of the sample. (3) The Authority shall, upon being satisfied that the issued results were correct, notify the customer within fourteen days after completion of the review. (4) Subject to subregulation (3), where the customer is aggrieved by the decision of the Authority he may request to witness the testing of the samples. 17 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) (5) In witnessing the testing of the samples, the Authority shall conduct the analysis of the samples in the presence of the customer or his representative. (6) Subject to subregulation (5), where the results are still disputed, an agreement shall be made between the customer and the Authority to send samples to an alternative laboratory for analysis. (7) Subject to subregulation (6), the cost of analysis shall be borne by the customer. (8) Subject to subregulation (6), the Authority in agreement with the customer may re-sample products from the agreed source to avoid any testing bias. (9) Subject to subregulation (6), in case of contradicting results between the TMDA laboratory and the contracted laboratory, an alternative laboratory shall be sought for testing of the samples upon shared cost to settle the dispute and the results shall be final. PART VIII LABORATORY TECHNICAL COMMITTEE Establishment of Committee
Part
PART VIII
- 29 Verify source ↗
Responsibility of Secretariat to Committee
AI-assisted research summary: This section is titled “Responsibility of Secretariat to Committee.”
29. Responsibility of Secretariat to Committee. - 30 Verify source ↗
Committee may regulate its own proceedings
AI-assisted research summary: The Committee may regulate its own proceedings.
30. Committee may regulate its own proceedings. - 34 Verify source ↗
Quorum
AI-assisted research summary: This provision is titled “Quorum.”
34. Quorum. 2 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) - 38 Verify source ↗
Liability of members
AI-assisted research summary: Section 38 is titled “Liability of members.”
38. Liability of members. PART IX APPOINTMENT OF ANALYSTS - 26 Verify source ↗
(1) Subject to the provisions of the Act, there
AI-assisted research summary: A Laboratory Technical Committee is established to advise the Director General on analysis of regulated and non-regulated products.
26.-(1) Subject to the provisions of the Act, there shall be a Committee to be known as Laboratory Technical Committee to advise the Director General on matters related to analysis of regulated and non-regulated products. (2) The Committee shall be composed of members with knowledge and experience fields of pharmaceutical analysis, quality control and quality laboratory assurance, microbiology, technology, biomedical engineering, biotechnology, radiology, statistics, or any other related field. chemistry, the in Functions of Committee - 27 Verify source ↗
The Committee may advice the Director
AI-assisted research summary: The Committee may advise the Director General on laboratory-related matters listed in the section.
27. The Committee may advice the Director General on the following: (a) development and validation of analytical methods; (b) analysis of products; regulated and non-regulated (c) development of training programmes; 18 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Chairman and secretariat Responsibility of secretariat to Committee (d) management of accreditation schemes; (e) review of analytical processes and how to improve them; (f) propose and review areas of research; (g) matters related to costs of analysis including fees and charges; (h) waste management practices; (i) laboratory quality management systems; (j) laboratory information management system; (k) any other matters related to the operations of laboratory. - 28 Verify source ↗
(1) The Chairman of the Committee shall be
AI-assisted research summary: The Chairman must guide and chair Committee meetings, and the Authority must provide secretariat services to the Committee.
28.-(1) The Chairman of the Committee shall be elected from amongst the members. (2) The Chairman shall guide and chair the proceedings of the Committee meetings. (3) In the absence of the Chairman, the Acting Chairman shall be elected from amongst the members to preside over the meeting. (4) The Authority shall provide the secretariat services to the Committee. - 29 Verify source ↗
The responsibility of the secretariat shall be to
AI-assisted research summary: The secretariat must carry out committee support tasks, and the Committee may regulate its own proceedings.
29. The responsibility of the secretariat shall be to- (a) provide leadership and strategic advice on management of the Committee; (b) distribute notice of meetings and respective documents; (c) work in close collaboration with the Chairman to ensure efficient and effective performance of the Committee; (d) prepare agenda items of the meetings; (e) take minutes and keeping records of the meetings; and (f) provide logistical support to Committee members. Committee may regulate its own proceedings - 30 Verify source ↗
Subject to the provisions of these Regulations,
AI-assisted research summary: The Committee may regulate its own proceedings, but only subject to these Regulations.
30. Subject to the provisions of these Regulations, the Committee shall regulate its own proceedings. 19 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Co-option of experts Tenure of Committee Cessation of membership - 31 Verify source ↗
The Committee may, during its deliberation at
AI-assisted research summary: The Committee may invite a person with special knowledge or skills to attend meetings to provide expertise on a matter being discussed.
31. The Committee may, during its deliberation at any meeting, co-opt any person with special knowledge or skills to attend any of its meetings for purposes of providing expertise on a particular matter when deliberating its business. - 32 Verify source ↗
Members of the Committee shall serve for a
AI-assisted research summary: Committee members must serve a three-year term and may be eligible for one reappointment.
32. Members of the Committee shall serve for a period of three years and may be eligible for reappointment for one further term. - 33 Verify source ↗
A member shall cease his membership upon
AI-assisted research summary: A member must cease membership if any listed event happens, including missing three consecutive committee meetings, resigning in writing to the Authority, termination by the Authority, dissolution of the Committee, conviction leading to imprisonment over six months, or death.
33. A member shall cease his membership upon occurrence of the following- (a) failing to attend three consecutive Committee meetings; (b) resignation at any time upon written notification to the Authority; (c) termination by the Authority on grounds of poor performance or any other reason thereof that may be judged to impair his performance; (d) dissolving the Committee on grounds of poor performance, conduct or absence of the need of such Committee; (e) conviction of any offence and sentences to imprisonment for a period exceeding six months; or (f) death. Quorum - 34 Verify source ↗
The quorum during Committee meetings shall
AI-assisted research summary: Committee meetings require a quorum of fifty plus one percent of members.
34. The quorum during Committee meetings shall be fifty plus one percent of members. Meetings of Committee - 35 Verify source ↗
(1) The Committee may hold an ordinary
AI-assisted research summary: The Committee may hold ordinary meetings at least twice a year, the Authority may call extra ordinary meetings when needed, and members who cannot attend for known reasons may submit written comments but may not send a representative.
35.-(1) The Committee may hold an ordinary meeting at least twice a year. (2) The Authority may convene extra ordinary meeting at any time when deemed necessary. (3) Any member who is unable to attend a meeting for known reasons may be allowed to submit written comments on the matter under discussion but shall not be allowed to send a representative to attend on his behalf. 20 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Disclosure of conflict of interest (4) The Committee shall provide specialist advice after reaching consensus. - 36 Verify source ↗
(1) Any member of the Committee shall refrain
AI-assisted research summary: Committee members must avoid conflicts with their role and must follow the relevant ethics and public service codes, including declaring conflicts of interest.
36.-(1) Any member of the Committee shall refrain from any undertaking that conflict his roles as Committee member. (2) Any member of the Committee shall be required to observe respective professional code of ethics and public service code of conducts including declaration of conflict of interest. Remuneration of members - 37 Verify source ↗
While attending Committee meetings, members
AI-assisted research summary: Members and the secretariat are to be paid when attending Committee meetings, using the stated financial regulations or any decision made by the Director General.
37. While attending Committee meetings, members and the secretariat shall be remunerated in accordance with Internal Financial and Staff the existing TMDA Regulations, government financial regulations or as may be decided by the Director General. Liability of members - 38 Verify source ↗
Anything done by a member while executing
AI-assisted research summary: A member acting under these Regulations in good faith is not personally liable for what they do.
38. Anything done by a member while executing activities under these Regulations if done in good faith, shall not render such a member personally liable for the matter or thing done. PART IX APPOINTMENT OF ANALYSTS Appointment
Part
PART IX
- 42 Verify source ↗
Conflict of interest
AI-assisted research summary: Section title only: Conflict of interest.
42. Conflict of interest. PART X HANDLING OF LEGAL SAMPLES - 39 Verify source ↗
Appointment of analysts shall be as prescribed
AI-assisted research summary: Appointment of analysts must follow the procedure set out in the Act.
39. Appointment of analysts shall be as prescribed in the Act. Qualifications - 40 Verify source ↗
Subject to regulation 39, in appointing analysts,
AI-assisted research summary: When appointing analysts, the Minister must consider the listed disciplines, subject to regulation 39.
40. Subject to regulation 39, in appointing analysts, the Minister shall consider the following disciplines: (a) Pharmacy; (b) Laboratory Technology; (c) Medical Laboratory Science; (d) Pharmaceutical Technology; (e) Chemistry; (f) Microbiology; (g) Biotechnology; (h) Biomedical Engineering; (i) Biomedical Science; or 21 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) (j) Radiology. Gazetting Conflict of interest - 41 Verify source ↗
Analysts appointed under regulation 39, shall be
AI-assisted research summary: Analysts appointed under regulation 39 must be gazetted in the official Government Gazette and receive identification cards issued by the Authority.
41. Analysts appointed under regulation 39, shall be gazetted in the official Government Gazette as provided under the Act and assigned identification cards issued by the Authority. - 42 Verify source ↗
Any appointed analyst shall refrain from any
AI-assisted research summary: Any appointed analyst must avoid work that could conflict with their roles and must declare any potential interest in writing to the Authority.
42. Any appointed analyst shall refrain from any undertaking that may conflict with his roles and where the analyst has any potential interest declare the same in writing to the Authority. Collection of samples GN. No. 312 of 2015 Safe custody of samples PART X HANDLING OF LEGAL SAMPLES
Part
PART X
- 45 Verify source ↗
Analysis of samples
AI-assisted research summary: This provision is headed “Analysis of samples.”
45. Analysis of samples. PART XI ACCREDITATION AND TRAINING - 43 Verify source ↗
(1) Samples collected for legal proceedings
AI-assisted research summary: Samples for legal proceedings must be split into three parts: one for the customer, one for the Authority, and one to be analysed.
43.-(1) Samples collected for legal proceedings shall be divided into three parts, whereby one portion shall be retained by the customer, the second portion by the Authority and the third to be analysed. (2) Collection and apportioning of samples under subregulation (1), shall be done by the inspector and each part shall be marked, sealed and secured in the manner permitted by its nature. (3) When collecting samples, the customer or his representative, shall be available to witness and sign sample collection form prescribed in the Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials Regulations, 2015.
Part
PART XI
- 46 Verify source ↗
Powers to accredit medical laboratories
AI-assisted research summary: This section is titled “Powers to accredit medical laboratories.”
46. Powers to accredit medical laboratories. - 49 Verify source ↗
Section 49
AI-assisted research summary: Section 49 is titled “Issuance of accreditation certificate.”
49. Issuance of accreditation certificate. - 50 Verify source ↗
Validity of accreditation certificate
AI-assisted research summary: Section 50 is titled “Validity of accreditation certificate.”
50. Validity of accreditation certificate. - 52 Verify source ↗
Renewal of accreditation certificate
AI-assisted research summary: Section 52 is titled “Renewal of accreditation certificate.”
52. Renewal of accreditation certificate. - 55 Verify source ↗
Section 55
AI-assisted research summary: This section is titled “Issuance of training certificates.”
55. Issuance of training certificates. PART XII NATIONAL AND INTERNATIONAL COLLABORATIONS - 46 Verify source ↗
(1) The Authority shall have powers to accredit
AI-assisted research summary: The Authority may accredit public and private medical laboratories to confirm they are competent to provide the services covered by these Regulations.
46.-(1) The Authority shall have powers to accredit public and private medical laboratories to ensure that they have the competence to offer the services defined in the scope of these Regulations. (2) Subject to subregulation (1), the accreditation services to medical laboratories shall be given in the following disciplines: (a) clinical biochemistry; (b) hematology; (c) microbiology and infectious diseases serology; (d) molecular testing; (e) diagnostic radiology; (f) QA testing; (g) any other service as it may deem fit. (3) Without prejudice the provisions of licensing of private health subregulation laboratories shall be in accordance with the Private Health Laboratory Regulation Act. (1), the to Cap. 136 Scope of accreditation services - 47 Verify source ↗
The Authority shall offer accreditation services
AI-assisted research summary: The Authority must offer accreditation services for the areas named by the medical laboratory in its accreditation application form.
47. The Authority shall offer accreditation services to the areas specified by the medical laboratory in the accreditation application form. Application for accreditation - 48 Verify source ↗
An application for accreditation submitted to
AI-assisted research summary: An application for accreditation submitted to the Authority must include a completed application form, a Laboratory Information File or Laboratory Quality Manual, and the application fees.
48. An application for accreditation submitted to the Authority shall be accompanied by the following: (a) dully filled application form for accreditation of medical laboratories in the format and content as specified by the Authority; (b) Laboratory Information File (or Laboratory Quality Manual) in the format and content as specified by the Authority; and (c) application fees as specified in the fees and charges regulations. 23 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Issuance of accreditation certificate Validity of accreditation certificate Surveillance audits Renewal of accreditation certificate Extension of scope Training services - 49 Verify source ↗
The Authority shall conduct audit of the
AI-assisted research summary: The Authority must conduct an audit of the medical issue, linked to an accreditation certificate in Form No. 4.
49. The Authority shall conduct audit of the medical issue and upon accreditation certificate in Form No. 4 set out in the First Schedule to these Regulations. satisfaction laboratory
Part
PART XII
- 57 Verify source ↗
Section 57
AI-assisted research summary: This section is titled “International cooperation.”
57. International cooperation. 3 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) - 58 Verify source ↗
Harmonisation of laboratory requirements
AI-assisted research summary: This section is titled “Harmonisation of laboratory requirements.”
58. Harmonisation of laboratory requirements. PART XIII CONFIDENTIALITY OF DATA AND RECORD KEEPING - 56 Verify source ↗
In the performance of its functions, the
AI-assisted research summary: The Authority may maintain consultation and cooperation with other laboratories while performing its functions.
56. In the performance of its functions, the Authority may strive to maintain a system of consultation and cooperation with other laboratories to include- (a) Government Chemist Laboratory; (b) National Institute for Medical Research Laboratory; (c) the Tanzania Atomic Energy Commission Laboratory; (d) Tanzania Bureau of Standards Laboratory; (e) National Health Laboratory Quality Assurance and Training Centre; (f) Tanzania Veterinary Laboratory Agency; (g) Tanzania Pesticide Research Institute Laboratory; and (h) any other laboratory established by or under any other written laws. International cooperation - 57 Verify source ↗
(1) The Authority may cooperate with regional
AI-assisted research summary: The Authority may cooperate with laboratories and share laboratory results, especially for products that pose public health risks.
57.-(1) The Authority may cooperate with regional 25 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) and international laboratories on matters related to analysis of products under these Regulations. (2) The Authority may collect and share laboratory results for products that pose public health risks with other bodies at regional and international levels. Harmonisation of laboratory requirements 59-The Authority may participate in regional and international laboratory harmoniation initiatives that aim at- (a) harmonising systems for analysis of products, quality management, information management and any other laboratory activities as may be appropriate; (b) providing for the use of accredited quality control laboratories within the harmonisation framework; (c) providing for the recognition of regional, continental and other international technical laboratory guidelines; (d) participating in intra and inter laboratory proficiency testing schemes; (e) participating in post-marketing surveillance activities; and (f) establishing networks with other laboratories and collaborate in protecting public health. PART XIII CONFIDENTIALITY OF DATA AND RECORD KEEPING Confidentiality
Part
PART XIII
- 61 Verify source ↗
Archiving and record keeping
AI-assisted research summary: This section is titled “Archiving and record keeping” and appears under the general provisions part.
61. Archiving and record keeping. PART XIV GENERAL PROVISIONS - 59 Verify source ↗
(1) All data generated in the laboratory
AI-assisted research summary: Laboratory data, including analysis results, must be treated as confidential. Laboratory staff must sign a confidentiality form issued by the Authority, and the Authority may disclose confidential information only under a court order or other lawful directive.
59.-(1) All data generated in the laboratory treated as including results of analysis shall be confidential information. (2) Subject to subregulation (1), all staff working in the laboratory shall sign a confidentiality agreement form issued by the Authority. (3) Disclosure of any confidential information by the Authority shall only be made upon order of the court or any other lawful directive. 26 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Electronic data management Archiving and record keeping - 60 Verify source ↗
(1) The Authority shall maintain an electronic
AI-assisted research summary: The Authority must maintain a secure electronic data management system, control access with individual usernames and passwords, keep an audit trail, and retain most records for five years.
60.-(1) The Authority shall maintain an electronic data management system to allow for safe custody of data generated in the laboratory. (2) Subject to subregulation (1), access to the electronic data management system shall be controlled through use of individual username and password. (3) Subject to subregulation (1), the electronic data management systems shall allow for an audit trail to be conducted to provide source, sequence and evidence of data stored. 61-(1) The Authority shall keep and maintain traceability and to allow for laboratory reproducibility of results. records (2) The records referred to in subregulation (1), shall include: (a) test request forms; (b) analysis request forms; (c) sample analysis reports; (d) certificates of analysis; (e) procurement and supplies records; (f) equipment calibration and maintenance records; preventive (g) environmental monitoring records; (h) validation master plan and records; (i) disposal records; (j) training records; (k) accreditation records; (l) customer records; complaints and compliments (m) change and out of specification records; (n) laboratory events records including spill- overs; (o) reference and working standards records; (p) process flow charts and standard operating procedures; and (q) any other records as it may deem necessary. 27 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Appeals (3) Subject to subregulation (1), all electronic and paper-based records except training records shall be retained for a period of five years before disposal. PART XIV GENERAL PROVISIONS
Part
PART XIV
- 63 Verify source ↗
Offences and penalties
AI-assisted research summary: This provision is titled “Offences and penalties,” but the provided text does not state any actual rule or penalty details.
63. Offences and penalties. _________ SCHEDULES _________ 4 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) THE TANZANIA MEDICINES AND MEDICAL DEVICES ACT, (CAP. 219) _________ REGULATIONS _________ (Made under section 122(1) (t) and (z)) _________ THE TANZANIA MEDICINES AND MEDICAL DEVICES (LABORATORY ANALYSIS OF MEDICAL AND NON-MEDICAL PRODUCTS) REGULATIONS, 2021 Citation Application Interpretation Cap. 219 PART I PRELIMINARY PROVISIONS - 62 Verify source ↗
(1) Notwithstanding the provisions of these
AI-assisted research summary: A person aggrieved by an Authority decision may appeal in writing to the Minister within 60 days.
62.-(1) Notwithstanding the provisions of these Regulations, any person aggrieved by a decision of the Authority may, within sixty days, appeal in writing to the Minister. (2) The appellant shall copy the appeal to the Authority who shall within fourteen days submit a written response to the Minister and a copy to the appellant. (3) Where the Minister is of the opinion that a case has been made, he may summon parties for additional information or make a decision to allow or dismiss the appeal. Offences and penalties - 63 Verify source ↗
Any person who contravenes or fails to comply
AI-assisted research summary: Any person who breaks these Regulations, or helps someone else do a prohibited act, commits an offence and may be liable to a penalty set out in the Act.
63. Any person who contravenes or fails to comply with these Regulations or directly or indirectly aids any other person to do what is prohibited under these Regulations commits an offence and on conviction, shall be liable to a penalty prescribed in the Act. ________ SCHEDULES _________ _________ FIRST SCHEDULE _________ FORMS 28 F ORM NO. 1 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) (Made under regulation 13(1) (a)) TEST REQUEST FORM Laboratory code number…………………………………………………… Customer’s name and address…………………………………………… Customer code number (if applicable) ………………………………… Sample Information Product name (including brand name, form and strength if applicable)……… Description (appearance of container & contents): …………………………………. Batch number……… Expiry date………Manufacturing date ………….. Manufacturer …………………………………………………… Sample size (quantity): ………………Submission date ………………………… Reason(s) for requesting the analysis……………………………………….. Sample submitted by……………………….. Signature......................... S/N Test requested S/N Test requested Statement of conformity required: YES/NO (tick as appropriate) Applicable decision rule (If required)……………………………………………………… Analysis fees and charges………………………………………………………...... Customer name: ……………………... Signature: ....................... Date: ……………… I accept/reject to carry out tests specified above Laboratory Manager (LM) or Laboratory Supervisors (LS) Remarks (In case of rejection)……………………................................................................................... LM or LS name: ………………………… Section…………………………………. Signature: ....................... Date: …………………………… Subcontracting Agreement for sub-contracting work: YES or NO (tick as appropriate) If no Reason (s) ………………………………………………………………………………. LM or LS (Signature)……………….….........Date…………… Customer (Signature): ............................. Date…………… Test request deviation or amendment/ additional test(s) (when applicable)……………………………………………………………………………………… Customer Name…………………… LM or LS Name……………… Signature …………………………. Date… …………………… Date………………………… LM or LS signature ……………….. 29 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) F ORM NO. 2 (Made under regulation 17(2)) CERTIFICATE OF ANALYSIS Lab code #: …………………………. Name of the laboratory: …………………………. Customer name and address: ……………………………………………………………………………… Tanzania Medicines and Medical Devices Authority (TMDA) Laboratory do hereby certify that, it has received on the ………day of …………… from ……………………………….. sealed or unsealed pack marked ………………………. TMDA analysed the contents of the pack, and do hereby declare the results of analysis as follows: Product Name: ……………………………………………………………………………………………… Product Form/Presentation: ………………………………………………………………………………… Customer Code/Application No: …………………………………………………………………………. Manufacturer: …………………………………….. …………………………… Date of Manufacture: ……………………………. ……………………………… Lot/Batch No.: Expiry Date: Date of Analysis: ………………………………….. Active Ingredient(s) (If applicable): ………………………………………………………. Product Specification: (If applicable)………………………………………………………… Test parameter (s) Method Specification (s) Result (s) Remarks (Pass/Fai l) CONCLUSION: ………………………………………………………………………………………………………… ………………………………………………………………………………………………………… ……………………………… 30 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Analyzed by (Analyst) Reviewed by (Laboratory Manager or Supervisor) Approved by (Director of Laboratory Services or Laboratory Head) Name Signature Date 31 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) CERTIFICATE OF CONFORMITY (Made under regulation 17(2)) FORM NO. 3 Lab code #: …………………………. Name of the laboratory: …………………………. Customer name and address: ……………………………………………………………………………… Tanzania Medicines and Medical Devices Authority (TMDA) Laboratory do hereby certify that, it has received on the ………day of …………… from ……………………………….. sealed or unsealed pack (where applicable) marked ………………………. TMDA tested or analyzed the device or diagnostic (where applicable) and do hereby declare the results as follows: Device or Diagnostic Name: ……………………………………………………………………………… Physical appearance: ………………………………………………………………………………………. Customer Code/Application No: …………………………………………………………………………. Manufacturer: …………………………………….. …………………………… Date of Manufacture (where applicable): ……………………………. Expiry Date (where applicable): ………………………………………. Lot or Serial No.: Date of testing or analysis: ………………………………….. Device or Diagnostic specification: (If applicable)………………………………………………………… Test parameter (s) Method Specification (s) Result (s) Remarks (Pass/Fa il) CONCLUSION: ………………………………………………………………………………………………………… ………………………………………………………………………………………………………… ……………………………… Tested or analyzed by (Analyst) Reviewed by (Laboratory Manager or Supervisor) Approved by 32 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) (Director of Laboratory Services or Laboratory Head) Name Signature Date FORM NO. 4 (Made under regulation 49) ACCREDITATION CERTIFICATE 33 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) (Made under regulation 56) TRAINING CERTIFICATE FORM NO. 5 Tanzania Medicines and Medical Devices Authority Qaulity Control Laboratory Accrediatation Services Certificate of Accreditation The Tanzania Medicines and Medical Devices Authority’s Quality Control Laboratory has assessed the Laboratory of Name of the Laboratory being accredited Physical address of the laboratory being accredited (Hereinafter called the Organization) and hereby declares that the Organization is accredited in accordance with the recognized TMDA Standard: Standard Code name and number This accreditation demonstrate technical competence for defined scope and operation of a laboratory quality management system (As outlined by the joint…..dated…...) Chemical Testing of ……………………………………… (As detailed in the supplement) Accreditation claims for such testing and/or calibration services shall only be made from addresses referenced within this certificate. This Accreditation is granted subject to the system rules governing the Accreditation referred to above and the Organization hereby covenants with the Accreditation 34 body’s duty to observe and comply with the said rules. For TMDA ------------ Director General Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) 35 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) ____________ SECOND SCHEDULE ____________ (Made under regulation 13(2)) MINIMUM NUMBER OF UNITS REQUIRED FOR CHEMICAL AND MICROBIOLOGICAL TESTING Formulation Pack Size Minimum Sample Submission No .
Part
PART I
- 1 Verify source ↗
These Regulations may be cited as the Tanzania
AI-assisted research summary: These Regulations may be cited as the Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) Regulations, 2021.
1. These Regulations may be cited as the Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) Regulations, 2021. - 2 Verify source ↗
These Regulations shall apply in the laboratory
AI-assisted research summary: These Regulations apply to laboratory analysis in Mainland Tanzania for regulated and non-regulated products, including medicines, medical devices, diagnostics, medical gases, soil, human and animal biological specimens, and hospital supplies.
2. These Regulations shall apply in the laboratory analysis of regulated and non-regulated products to include medicines, medical devices, diagnostics, medical gases, soil, human and animal biological specimens and hospital supplies in Mainland Tanzania. - 3 Verify source ↗
In these Regulations, unless the context
AI-assisted research summary: This section defines key terms used in the Regulations.
3. In these Regulations, unless the context otherwise requires- “accreditation” means the formal recognition of a laboratory by the Authority in relation to the competence of the laboratory to conform to specified standards; “Act” means the Tanzania Medicines and Medical Devices Act; “agreement” means the arrangement undertaken by and legally binding on parties; “analyst” means a person designated as such under the Act; 5 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) “analyst blinding” means the process by which an analyst is kept unaware of the identity of a sample allocated to him for analysis to avoid results bias; “animal biological specimens” means any material drawn from animals such as blood, urine, tissues, organs, saliva, spinal fluid, hair, nail clippings, or any other material of animal origin; “Authority” means the Tanzania Medicines and Medical Devices Authority or by its acronym “TMDA” established under the Act; “batch” or “lot” means a defined quantity of a product manufactured in a single manufacturing cycle and which has homogeneous properties; “certificate” means a certificate issued by the Authority under these Regulations; “commercial samples” means samples submitted by the customer for testing purposes which do not form part of marketing authorisation; “contract” means a legally binding agreement between the Authority and the customer for the performance of any laboratory related work at a specified price; “controlled drug samples” means samples of any narcotic drug, psychotropic substance or precursor as listed under the Act; “country of origin” means a country in which the product has been manufactured or supplied; “customer” means a person who receives laboratory services offered by the Authority; “Director General” has the meaning ascribed to it under the Act; “disposal” means the process of donating samples fit for human consumption or rendering unfit samples or laboratory wastes such that they are harmless; “hospital supplies” means items that used for curative, prosthetic or medical care in the health facilities; “human biological specimens” means any material drawn from a human being such as blood, urine, tissues, organs, saliva, spinal fluid, hair, nail clippings, or any other material of human origin; 6 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) “inspector” means a person appointed, authorised or recognised as such under the Act; “manufacture” means all operations involved in the production, preparation, processing, compounding, formulating, filling, refining, transformation, packing, packaging, re- packaging and labelling of regulated and non- regulated products; “manufacturer” means a person or firm that is engaged in the manufacture of a product regulated under the Act; “medical products” means medicines, medical devices or diagnostics; “medicinal product” means a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify a physiological pharmacological, immunological or metabolic action; functions exerting by “medical device” has meaning ascribed to it under the Act; “method validation or verification” means an action of proving and documenting that any procedure, process, activity or system will, with a high degree of assurance, lead to the expected results; “Minister” means the Minister responsible for health; “non-medical products” means all products that do not meet the definition of a medicine, medical device or diagnostics as set out in these Regulations; “non-regulated products” means products other than regulated products; “post marketing surveillance programme” means a programme for sampling and testing selected medical products to assess their quality after marketing authorisation; “quality assurance programme” means a programme designated by the Authority to sample and test selected products imported into the country before release to the market; 7 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) “quality management system” means coordinated activities, processes and procedures focused on ensuring quality and consistently meeting customer requirements including enhancing their satisfaction; “regulated products” means medicines, medical devices, diagnostics, laboratory equipment, blood and blood products, medical gases, antiseptics, disinfectants and other related medical products and health technologies; “risk management” means a systematic process for the assessment, control, communication and review of risks to the quality of services; “sample” means a portion of a material or product collected for testing according to a defined sampling procedure; “sampling” means operations designed to obtain a representative portion of a material or product, based on an appropriate statistical approach for a defined purpose include acceptance of consignments or batch release; to “specifications” means a list of tests, references to analytical procedures and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described; “sub-contracting” means the process of entering a contractual agreement with a third party laboratory to perform analysis of products on behalf of the Authority; “substance” means any natural or artificial substance, whether in solid or liquid form or in the form of a gas, vapour or radiation; and “testing bias” means a systematic error from unfair sampling and testing that does not estimate or give accurate results. PART II POWERS OF THE AUTHORITY IN LABORATORY ANALYSIS 8 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) General powers
Part
PART II
- 4 Verify source ↗
(1) Subject to the provisions of the Act, the
AI-assisted research summary: The Authority has power to conduct laboratory analysis and do whatever is necessary or desirable to carry out these Regulations, subject to the Act.
4.-(1) Subject to the provisions of the Act, the Authority shall have powers to conduct laboratory analysis and all things which are necessary or desirable to give effects to the provisions of these Regulations. (2) Nothing in these Regulations shall be construed to limit or affect in any way the Authority’s power to take actions or any other measures under these Regulations, the Act or other applicable laws. Powers of Authority to analyse regulated and non-regulated products - 5 Verify source ↗
For the purposes of analysing regulated and non
AI-assisted research summary: The Authority must carry out sample collection, testing support, method development, training, and accreditation activities for regulated and non-regulated products.
5. For the purposes of analysing regulated and non- regulated products, the Authority shall- (a) take samples of medicines, medical devices and diagnostics as specified in the Act; (b) receive commercial samples from different customers for testing in its laboratories; (c) receive samples of non-regulated product samples from different customers for testing in its laboratories; (d) sub-contract testing of samples when need arise; regulated product (e) develop and validate methods of analysis of products; (f) offer training services on laboratory analytical industry experts, students, techniques institutions and other stakeholders from within or outside Mainland Tanzania; and to (g) offer accreditation to various institutions to comply with laboratory quality management system requirements. services PART III SAMPLE CATEGORIES Types of samples
Part
Schedule, respectively.
- 14 Verify source ↗
(1) The Authority shall receive samples in their
AI-assisted research summary: The Authority must accept samples only if they are in their original, untampered containers, check them on receipt, and record submitted samples. For foreign samples, the customer must pay shipping and clearance costs.
14.-(1) The Authority shall receive samples in their original containers and which have not been tampered with. (2) For samples from foreign countries, all shipping and clearance costs shall be borne by the customer. (3) Upon receipt of samples the Authority shall verify the physical appearance, completeness of test request forms and proof of payment. (4) Samples submitted shall be recorded in the sample receiving register specified in the Fourth Schedule to these Regulations. - 15 Verify source ↗
(1) Samples received shall be stored
AI-assisted research summary: The Authority must store received samples according to the manufacturer’s instructions, blind analysts when assigning samples for analysis, and maintain preservation and storage conditions during handling.
15.-(1) Samples received shall be stored in accordance with the manufacturer’s instructions. (2) In assigning samples for analysis measures shall be taken by the Authority to blind analysts to avoid testing bias. (3) In handling of samples during analysis, preservation and storage conditions of samples at all stages shall be maintained by the Authority. - 16 Verify source ↗
(1) Analysts shall ensure that assigned samples
AI-assisted research summary: Analysts must ensure assigned samples are tested using the agreed analytical methods.
16.-(1) Analysts shall ensure that assigned samples are tested as per agreed analytical methods. (2) Subject to subregulation (1), when testing samples all measures shall be taken to ensure that all including equipment have been calibrated, methods verified and validated as appropriate for the intended purpose. - 17 Verify source ↗
(1) The Authority shall issue a certificate of
AI-assisted research summary: The Authority must issue a certificate of analysis for tested samples, and the certificate must follow the prescribed form and content.
17.-(1) The Authority shall issue a certificate of analysis to authenticate that samples were tested and found to either comply or not comply with specifications. (2) Subject to subregulation (1), the certificate of analysis or testing issued shall be in the format and content as prescribed in Form No. 2 set out in the First Schedule for medicinal products and Form No. 3 set out in the in First 14 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Schedule for medical devices and diagnostics to which a certificate of analysis do not apply. PART V SUB-CONTRACTING TESTING Identifying and selecting testing laboratories
Part
part shall be marked, sealed and secured in the manner
- 44 Verify source ↗
(1) Samples collected for legal proceedings
AI-assisted research summary: Samples collected for legal proceedings must be stored securely, in line with the manufacturer’s instructions, and kept as exhibit samples until the proceedings are settled.
44.-(1) Samples collected for legal proceedings including those submitted by law enforcement agencies shall be stored in accordance with the manufacturer’s instructions, in a secured place, with special coding and under lock and key. (2) Subject to subregulation (1), such samples shall be stored as exhibit samples until after the legal proceedings have been settled. 22 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) Analysis of samples - 45 Verify source ↗
Subject to regulations 44 and 45, analysis of
AI-assisted research summary: Analysis of samples must follow Part IV, subject to regulations 44 and 45.
45. Subject to regulations 44 and 45, analysis of samples shall be as specified in Part IV. PART XI ACCREDITATION AND TRAINING Powers to accredit medical laboratories
Part
Schedule to these Regulations.
- 50 Verify source ↗
The accreditation certificate issued under
AI-assisted research summary: An accreditation certificate issued under regulation 49 is valid for three years.
50. The accreditation certificate issued under regulation 49 shall be valid for a period of three years. - 51 Verify source ↗
The Authority may conduct surveillance audits
AI-assisted research summary: The Authority may conduct annual surveillance audits to help retain the accreditation certificate issued under regulation 49.
51. The Authority may conduct surveillance audits on annual basis to retain the accreditation certificate issued under regulation 49. - 52 Verify source ↗
The application for renewal of accreditation
AI-assisted research summary: An application to renew an accreditation certificate must be made to the Authority at least 90 days before the certificate expires.
52. The application for renewal of accreditation certificate shall be made to the Authority at least ninety days before its expiry by submitting the items listed under regulation 48. - 53 Verify source ↗
Where the applicant intends to extend the scope
AI-assisted research summary: If an applicant wants to extend the scope of accreditation, the applicant must submit written additional information to the Authority and include the applicable fees.
53. Where the applicant intends to extend the scope of accreditation, he shall express in writing and submit to the Authority relevant additional information including applicable fees as prescribed in the fees and charges regulations. - 54 Verify source ↗
(1) The Authority may offer training services to
AI-assisted research summary: The Authority may offer laboratory-related training services and may advertise them in official media when interest is received.
54- (1) The Authority may offer training services to various customers including laboratory personnel upon receipt of expression of interest to do so. (2) Subject to subregulation (1), the type of training to be offered shall include: (a) general management of the laboratory; (b) laboratory quality management systems; (c) analytical methods development and validation; (d) analytical techniques; (e) equipment preventive maintenance, calibration and qualification; (f) laboratory risk management; (g) health and safety; and (h) disposal and waste management. (3) Subject to subregulation (1), the Authority may advertise the training on any official media to invite 24 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) applications for training participation, as it may deem necessary. (4) Subject to subregulation (1), the training fees shall be as prescribed in the fees and charges regulations. (5) Subject to subregulation (4), the cost of participating in the training shall be advertised in the official call for expression of interest and determined depending on the type of training to be offered. Issuance of training certificates - 55 Verify source ↗
Upon completion of the training, the successful
AI-assisted research summary: After completing the training, successful candidates are to be issued a training certificate in Form No. 5.
55. Upon completion of the training, the successful candidates shall be issued with a training certificate in Form No. 5 set out in the First Schedule to these Regulations. PART XII NATIONAL AND INTERNATIONAL COLLABORATIONS National collaboration
Part
SCHEDULES
- 10 Verify source ↗
Active Pharmaceutical
AI-assisted research summary: This provision lists active pharmaceutical ingredient quantities in several package and unit forms.
10. Active Pharmaceutical Ingredient (s) 30 vials/ampoules 12 vials/ampoules 6 bottles 30 Sachets 15 Sachets 100 bottles 50 bottles 100 tablets/capsules 20 bottles 15 bottles 4 bottles 100 sachets 50 sachets 10 Packs 20 tubes 10 tubes 5 tubes 8 bottles 4 bottles 2 bottles 1 bottle 5 g 1000 mL ≤ 10 mL - 100 Verify source ↗
2000ml
AI-assisted research summary: The text lists several quantity thresholds in grams and millilitres, but does not state a complete rule.
100 - 2000ml 1-50g ≥ 50g < 10 mL > 10 mL All ≤ 10 mL - 50 Verify source ↗
250 mL
AI-assisted research summary: This table lists pack-size categories and the minimum sample submission requirements for medical devices and diagnostics testing.
50 – 250 mL 500-1000 mL 5000 mL Solids Liquids 36 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) __________ THIRD SCHEDULE ___________ (Made under regulation 13(2)) MINIMUM NUMBER OF UNITS REQUIRED FOR MEDICAL DEVICES AND DIAGNOSTICS TESTING Pack Size Minimum Sample Submission Product N o . - 13 Verify source ↗
Urine Pregnancy Test (UPT) Kit
AI-assisted research summary: Lists a urine pregnancy test (UPT) kit item and package counts.
13. Urine Pregnancy Test (UPT) Kit 25 tests 50 tests 4 kits 4 kits 4 kits 2 kits - 14 Verify source ↗
Absorbable surgical sutures
AI-assisted research summary: This section lists absorbable surgical sutures with associated quantities.
14. Absorbable surgical sutures All 20 units 144 units 144 units 13 units 9 units 2 rolls 213 units 213 units 20 units 1 roll 9 units 9 units 1 box 6 units 5 units - 10
AI-assisted research summary: This provision is a sample receiving register format listing the columns to record sample details and analysis quantities.
10 – 20 All Rolls 100/box 100/box All All All All 50 pcs All All 37 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) GN. NO. 685 (Contd.) ___________ FOURTH SCHEDULE __________ (Made under regulation 14(4)) SAMPLE RECEIVING REGISTER S/N Registration number of the sample Date of receipt Specific unit to which the sample was forwarded Number of units issued for analysis Number of units remaining after analysis 6th September, 2021 Dodoma, DOROTHY O. GWAJIMA Minister of Health, Community Development, Gender, Elderly and Children 38
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