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.   Illicit substances

   52.   Powers of search for illicit substances

   53.   Special jurisdiction

   54.   Vicarious liability relating to controlled substances

   55.   Onus of proof

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.

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)

 

1.   Short title

   This Act may be cited as the Medicines and Related Substances Act.

 

2.   Interpretation

   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 Cap. 61:02 Botswana Health Professions Act;

   “dispenser” means a pharmacist or any other health professional authorised in writing by the Director of Health Services, or a paraprofessional or veterinary surgeon authorized 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 Cap. 61:04 Veterinary Surgeons Act.

PART II
Medicines Regulatory Authority (ss 3-5)

 

3.   Establishment of Authority

   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.

 

4.   Functions of Authority

   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

   (r)   inspect and license privately owned medicine quality control laboratories.

 

5.   Appointment of officers and employees

   (1) The Authority shall have a Chief Executive Officer, appointed by the Minister on the recommendation of the Board, and on terms and conditions determined by the Board.

   (2) The Chief Executive Officer shall, subject to such directions as may be given by the Board, be charged with the management and control, administration and organisation of the Authority.

   (3) The Chief Executive Officer shall be assisted in his or her duties by such other senior officers as the Board may appoint on the recommendation of the Chief Executive Officer.

   (4) The Chief Executive Officer may, subject to the provisions of this Act, delegate the exercise of any of his or her powers under this Act, to any senior officer of the Authority.

   (5) The Chief Executive Officer shall appoint other officers and employees of the Authority.

   (6) The Chief Executive Officer may resign from office by notice in writing addressed to the Minister, and may be removed from office by the Minister.

PART III
Establishment of Board of Authority (ss 6-13)

 

6.   Establishment and functions of Board

   (1) There is hereby established a Board of the Authority, to be known as the Medicines Regulatory Board which, subject to the provisions of this Act, shall be responsible for the direction of the affairs and operations of the Authority.

   (2) Notwithstanding the generality of subsection (1), the Board shall—

   (a)   supervise and control the administration and financial management of the Authority; and

   (b)   formulate matters of policy for the purpose of providing general or specific guidance to the Authority in respect of the performance of its functions under this Act.

   (3) The Board may, at the request of any person and on the grounds of quality, safety or efficacy, carry out or cause to be carried out—

   (a)   investigations in respect of any particular medicine; and

   (b)   comparative studies, examinations or tests in respect of medicines of different makes or brands whether produced in Botswana or elsewhere.

 

7.   Membership

   (1) The Board shall consist of such persons and their alternates as may be appointed by the Minister, in writing, and after consultation with the Minister responsible for agriculture and the members shall be appointed from amongst persons with expertise in—

   (a)   law;

   (b)   pharmaceutical industry;

   (c)   business management;

   (d)   medicine;

   (e)   pharmacy;

   (f)   veterinary medicine; and

   (g)   two other areas as may be determined by the Minister.

   (2) The Chief Executive Officer, the Director of Health Services and the Director of Veterinary Services shall be ex-officio members of the Board.

   (3) The Minister shall appoint the Chairperson of the Board from amongst the members.

   (4) The Vice Chairperson of the Board shall be elected by the members from amongst themselves.

   (5) The Minister shall cause appointments to the Board to be published by notice in the Gazette, within 30 days of the appointments.

 

8.   Tenure of office

   A member shall hold office for a period of three years and shall be eligible

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