CHAPTER 63:04
MEDICINES AND RELATED SUBSTANCES
ARRANGEMENT OF SECTIONS
SECTION
PART I
Preliminary
1. Short title
2. Interpretation
PART II
Medicines Regulatory Authority
3. Establishment of Authority
4. Functions of Authority
5. Appointment of officers and employees
PART III
Establishment of Board of Authority
6. Establishment and functions of Board
7. Membership
8. Tenure of office
9. Disqualification
10. Removal and resignation of members
11. Filling of vacancy
12. Disclosure of interest
13. Confidentiality
PART IV
Meetings and Proceedings of Board
14. Proceedings of Board
15. Validity of decisions
16. Committees
17. Remuneration
18. Indemnity of members
PART V
Financial Provisions
19. Funds of Authority
20. Financial year
21. Accounts and audit
22. Annual report
PART VI
Control over Registration, Import, Export, Manufacture, Distribution, Sale and Dispensing of Medicines
23. Registration of medicines
24. Application for registration
25. Maintenance of register
26. Pharmaceutical operations
27. Manufacturing of medicines
28. Import, export, distribution or sale of medicines
29. Record keeping
30. Variation of authorisation
31. Importation of generic products
32. Post-marketing surveillance
33. Withdrawal of licence
34. Medicines in transit
35. Counterfeit products
36. Designation of ports
37. Disposal of unwanted medicines
PART VII
Classification of Medicines and Control of Certain Classes of Medicines
38. Classification and description of medicines
39. Prescriptions
40. Validity of prescriptions
41. Labelling of medicines
42. Storage and safe custody
43. Import and export of narcotics, psychotropics and precursors
44. Records of narcotics, psychotropics and precursors
45. Alteration of psychotropic substances or packaging
46. Advertising and promotion of medicines
47. Inspection of premises
PART VIII
Control over Veterinary Medicinal Products Related Matters
48. Preparation of premix
49. Feed mills
50. Control over residue limits
PART IX
Controlled Substances
51.–55 [Repealed.]
PART X
Medicines in Clinical Trials and Medical Research
56. Sale, etc. of medicine for clinical trial or medical research
57. Monitoring
PART XI
Sale, Manufacture, Labelling, etc. of Cosmetics
58. Sale of cosmetics
59. Unsanitary conditions
60. Therapeutic claims in cosmetics
61. Ingredients
62. Labelling of cosmetics
63. Safety of cosmetics
PART XII
Establishment of National Medicines and Therapeutics Board
64. National Medicines and Therapeutics Board
PART XIII
General
65. Appeals Committee
66. Offences generally
67. Repeal of Cap. 63:04
68. Savings and transitional provisions
69. Regulations
Act 8, 2013,
S. I. 8, 2016,
S.I. 9, 2017,
Act 39, 2018.
AN ACT to provide for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
[Date of Commencement: Parts I to V: 1st February, 2016;
Parts VI to XIII: 17th February 2017.]
PART I
Preliminary (ss 1-2)
This Act may be cited as the Medicines and Related Substances Act.
In this Act, unless the context otherwise requires—
"analyst" means a person with a degree in—
(a) chemistry;
(b) microbiology;
(c) pharmacy;
(d) pharmaceutical science;
(e) biomedicine;
(f) medical and pharmaceutical biotechnology, or an equivalent degree with proven technical competency in the analysis of medicine;
"Authority" means the Medicines Regulatory Authority established under section 3;
"Board" means the Board of the Authority, established under section 6;
"clinical trial or medical research on a medicine" means any investigation in humans or animals intended to—
(a) discover or verify the clinical, pharmacological or pharmacodynamic effects of an investigational medicinal product or medical device;
(b) identify any adverse reaction to an investigational medicinal product or medical device; or
(c) study the absorption, distribution, metabolism and excretion of an investigational medicinal product or medical device, with the object of ascertaining the safety and efficacy of the investigational medicinal product or medical device;
"controlled substance" means a prohibited substance or medicine listed in Schedules 1A, 1B, 1C, 1D, or a precursor chemical;
"cosmetic" means—
(a) any substance or mixture of substances manufactured, sold or represented for use by rubbing, pouring, spraying, or applying by any other means to the human body, for the purpose of cleansing, beautifying or altering the appearance; or
(b) any article intended for use as a component of a cosmetic;
"counterfeit product" means—
(a) a medicine;
(b) a cosmetic;
(c) a related substance; or
(d) a product—
(i) with correct ingredients,
(ii) with incorrect ingredients,
(iii) without active ingredients,
(iv) with insufficient ingredients, or
(v) with fake packaging;
which is deliberately or fraudulently mislabelled with respect to its identity or source;
"dentist" means a person registered as a dentist under the Botswana Health Professions Act (Cap. 61:02);
"dispenser" means a pharmacist or any other health professional authorised in writing by the Director of Health Services, or a paraprofessional or veterinary surgeon authorised in writing by the Director of Veterinary Services to dispense medicines within their scope of practice;
"dispensary" means any premises in which an authorised dispenser stores, handles, and dispenses medicine listed under Schedule 1, 2 or 3;
"distribution" means any practice whose activities involve the—
(a) handling;
(b) storing; or
(c) supplying,
of medicine for wholesale to pharmacies or dispensaries;
"emergency prescription" means medicine supplied by a pharmacist in a pharmacy, in an emergency, for a specified period of time and without a prescription;
"illicit substance" means any substance, natural or synthetic, which has been declared as an illicit substance by the Minister;
"inspector" means a person authorised in writing by the Medicines Regulatory Board and published in the Gazette as such, to inspect pharmaceutical operations;
"investigational medicinal product" means a medicine in pharmaceutical form of an active ingredient or placebo; or a medical device being tested or used as a reference in a clinical trial or medical research, including a product with marketing authorisation when used or assembled—
(a) in a way different from the approved form;
(b) for an unapproved indication; or
(c) used to gain further information about approved use;
"medicated feed" means a mixture of premix and animal feed;
"medical device" means an instrument, apparatus, implement, implant, medical equipment, machine, contrivance, or other related article, which is—
(a) used in the diagnosis, mitigation, treatment or prevention, of disease in man or animals; or
(b) used to affect the structure or function of the body of man or animals, and does not achieve any of its intended principal purposes through chemical action within the body, and is not dependent upon being metabolised for the achievement of any of its principal intended purposes;
"medical practitioner" means a person registered as a medical practitioner under the Botswana Health Professions Act;
"medical representative" means a person who promotes, markets, or advertises medicines;
"medicine" means—
(a) any substance, mixture combination of substances manufactured, sold, or presented for use in—
(i) the diagnosis, treatment, alleviation, modification or prevention of disease, illness, abnormal physical or mental condition or the symptoms thereof, or
(ii) restoring, correcting or modifying any somatic or psychic or organic condition; or
(b) any controlled substance, to the extent that it complies with paragraph (a);
(c) a substance or mixture of substances that is used to manufacture medicine or is sold as a raw material, a pre-cursor chemical or intermediate;
(d) any labelled preparation in pharmaceutical dosage form that contains as active ingredients, one or more substances of natural origin that are derived from plants or animals;
(e) herbal tea, or homeopathic, ayurvedic, or other, medicine that contains as active ingredients, substances of natural origin, and may be derived from any part of plants or animals in a pharmaceutical dosage form;
(f) vitamins and minerals prepared in a pharmaceutical dosage form;
(g) any medical device; or
(h) any premix;
"narcotic medicine" means any substance, in Schedules I, II and IV of the United Nations Single Convention on Narcotic Drugs, 1961;
"para-professional" means a person other than a veterinary surgeon, authorised by the Veterinary Surgeon Council to carry out designated duties relating to veterinary medicine under the supervision of a veterinary surgeon;
"pharmaceutical operation" means any premises or activities which deal in research, manufacturing, marketing, advertising, dispensing, distribution, storage or handling of medicines, or prohibited substances;
"pharmacist" means a person registered as a pharmacist under the Botswana Health Professions Act;
"pharmacy" means premises, labelled as such, licensed by the Medicines Regulatory Authority for the storing, dispensing, and selling of medicines, and which is under the continuous control and supervision of a pharmacist;
"pharmacy technician" means a person registered as such under the Botswana Health Professions Act;
"precursor chemical" means a substance, including its salts, isomers, derivatives, and analogues, that may be used frequently in the illicit synthesis or manufacture of narcotic medicines, psychotropic medicines, and illicit substances as provided for under the United Nations Convention Against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988;
"premix" means a mixture of one or more active pharamaceutical substances, solely intended for mixing into animal feed for production animals;
"prescriber" means a medical practitioner, veterinary surgeon, dentist, or any other health professional authorised in writing by the Director of Health Services or Director of Veterinary Services as the case may be, to prescribe within the scope of their practice, any medicine;
"prescription" means an order in writing, in a prescribed format, by a prescriber, for the supply of medicine or combination of medicines for the treatment of a person or animal specified in the order;
"prohibited substance" means any plant, preparation or substance, or mixture of substances, which has been declared as a prohibited substance by the Minister, by Order published in the Gazette;
"psychotropic medicines" means any substance under Schedules I, II, III and IV of the United Nations Convention on Psychotropic Substances, 1971;
"technician" means a person with a diploma or higher national diploma in—
(a) laboratory technology;
(b) medical or clinical laboratory;
(c) medical or clinical engineering; or
(d) animal health, or an equivalent related diploma with proven technical competency in the analysis of medicine, or the repair and management of medical devices; and
"veterinary surgeon" means a person registered as a veterinary surgeon under the Veterinary Surgeons Act (Cap. 61:04).
PART II
Medicines Regulatory Authority (ss 3-5)
There is hereby established an authority to be known as the Medicines Regulatory Authority, which shall be a body corporate capable of suing and being sued and, subject to the provisions of this Act, of performing such acts as bodies corporate may, by law, perform.
The functions of the Authority shall be to—
(a) ensure that—
(i) all medicines and related substances manufactured in, imported into, or exported from, Botswana are registered and conform to established criteria of quality, safety and efficacy, and
(ii) the personnel, premises and practices employed to manufacture, promote, procure, store, distribute and sell such medicines comply with defined codes of practice and other requirements;
(b) ensure that cosmetics manufactured in, imported into, or exported from Botswana are safe to use;
(c) perform sampling and establish a laboratory or other facilities for—
(i) the testing and analysis of medicines, for the determination of their compliance with standards of quality approved by the Minister on the recommendations of the Board, and for the issue of certificates with regard thereto, and
(ii) the inspection of privately owned medicine quality control laboratories;
(d) grant, renew, suspend or cancel, after due assessment, marketing authorisations for medicines, whether locally manufactured or imported and whether intended for local use or export;
(e) ensure that medicines are imported, manufactured, exported, stored, sold, distributed or otherwise dealt with by duly authorised persons;
(f) inspect or cause to be inspected, and license all domestic manufacturing premises, exporters, importers, wholesalers, distributors, clinics and hospital pharmacies, retail pharmacies, dispensaries and other outlets where medicines are dispensed or stored;
(g) inspect or cause to be inspected, premises where medicated feeds are used, handled or stored;
(h) ensure the monitoring and reporting of adverse reactions to medicines;
(i) ensure that the advertising of medicines is in accordance with this Act;
(j) monitor and review the implementation of this Act;
(k) prepare, modify or amend and publish any guidelines intended to be applied, or to be adopted in connection with the manufacture, testing, sampling, use, or safe disposal of any medicine;
(l) benchmark against foreign manufacturing premises, clinical research organisations, and testing premises seeking marketing authorisation for their products, for good manufacturing practice compliance and good laboratory practice compliance;
(m) encourage and undertake educational work in connection with the quality, safety and efficacy of medicines;
(n) conduct post marketing surveillance and control chemical precursors;
(o) do those things, or enter into those transactions that are expedient or necessary for the proper and efficient discharge of the functions of the Authority;
(p) control and monitor import, export, use, storage, and dispensing of controlled substances;
(q) grant approval of the use of medicine for clinical trials or medical research; and
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