Section 2(extract):
“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;
“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;
“premix” means a mixture of one or more active pharamaceutical substances, solely intended for
mixing into animal feed for production animals;

Section 3:
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.

Section 4:
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.