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 (extract):
The functions of the Authority shall be to-
...
(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;

Section 28 (extract):
(1) No person shall import, export, distribute or sell medicines except in accordance with a licence
issued for the import, export, distribution or sale of medicines in terms of this Act.

Section 48 (extract):
(1) The preparation of premix shall only be done at a feed mill authorised in the prescribed manner by the Authority acting in consultation with the Department of Veterinary Services, to manufacture medicated feed.

Section 49 (extract):
(1) No person shall operate a feed mill except in accordance with a licence issued by the Department of Veterinary Services.

Section 49 (extract):
(1) No person shall operate a feed mill except in accordance with a licence issued by the Department of Veterinary Services.

Section 26 (extract):
(1) No person shall practise as a pharmacist or operate a pharmacy or a dispensary on any premises unless-
a) the person has applied for and been issued with a licence in respect of the said premises
for operating the pharmacy or dispensary;
(b) the premises, in the case of a pharmacy, are under the continuous supervision of a
pharmacist; and
(c) in the case of a dispensary, the person is authorised in writing by the Director of Health Services or the Director of Veterinary Services as the case may be, to dispense.
Section 27 (extract):
(1) The manufacture of medicine may only be undertaken in an establishment licensed by the Authority.

Regulation 16 (extract):
(1) An application for licensing of pharmaceutical operations shall be submitted to the Authority, in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.
[…]
(6) The Authority shall keep a database of all licensed manufacturing facilities, pharmacies and pharmaceutical wholesalers.

Regulation 17 (extract)
(1) An applicant may apply to the Authority for a license to manufacture medicine in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.

Regulation 16 (extract):
(1) An application for licensing of pharmaceutical operations shall be submitted to the Authority, in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.
(2) The Authority may, having considered the application, grant the applicant a license in Form 9 set out in Schedule 4 and the Authority may attach conditions thereto as it may consider necessary.
(3) The Authority shall inform an unsuccessful applicant in writing, of the decision not to license the premises and the reasons, in line with the guidelines.

Regulation 17:
(1) An applicant may apply to the Authority for a license to manufacture medicine in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.
(2) The Authority shall grant a license in Form 9 set out in Schedule 4 subject to the submission of all the required documents according to the guidelines.

Section 26 (extract):
(5) Where the Authority is of the view that a pharmacy or dispensary is not being operated in accordance with good professional standards, the Authority may, in writing, suspend the licence issued in terms of subsection (2) pending compliance with any directions the Authority considers necessary, or cancel the licence where the non-compliance continues.
(6) Where a licence is cancelled under subsection (5), the licence holder shall dispose of the stock within six months and in a manner approved by the Authority.

Section 27 (extract):
(4) Where the Authority is satisfied that the conditions of any licence are not being observed, or that the manufacture of any medicine is not being carried out in accordance with the provisions of this Act or standards of good practice in the manufacture and quality control of medicines, the Authority may, after notice in writing to the licence holder, cancel the licence issued under this section.
(5) Where the Authority cancels a licence in terms of subsection (4), the licence holder shall cease all manufacturing.

Section 33:
(1) The Authority may withdraw a licence issued in terms of section 28 or 31 where the Authority is satisfied that the medicine is being imported, exported, distributed or sold otherwise than in accordance with the conditions of a licence issued under this Act.
(2) Where the Authority decides to withdraw a licence in terms of subsection (1), the Authority shall issue written notice to the importer, exporter, distributor or seller-
(a) stating the manner in which the importer, exporter, distributor or seller has contravened the
provisions of the Act; and
(b) allowing the importer, exporter, distributor or seller 21 days within which to comply with the
Act.
(3) Where the importer, exporter, distributor or seller does not, within 21 days of the written notice, comply with the requirement which led to the notice to withdraw the licence being issued, the Authority shall withdraw the licence or suspend the licence for a specified period pending compliance with any conditions set by the Authority.
(4) Where the Authority withdraws or suspends a licence in terms of this section, the importer, exporter or distributor shall forthwith cease all operations in respect of which the licence was issued.
(5) A person who knowingly supplies an importer, exporter, distributor, dispenser or seller-
(a) to whom a licence to carry out the import, export, distribution operation, sale or authorisation to dispense has not been issued; or
(b) whose licence to operate the import, export, distribution operation or sale or authorisation to dispense, as the case may be, has been withdrawn, commits an offence and is liable to a fine not exceeding three years, or to both.
(6) Where the Authority withdraws a licence issued in terms of this section, an inspector may close the premises from which the import, export, distribution operation or sale was being carried out.

Regulation 23:
(1) Where the licence holder does not meet the required standards and guidelines, the Authority may suspend or withdraw the license.
(2) The Authority shall notify the licence holder of the decision and may indicate the actions to be taken by the license holder and give the license holders seven days to respond.
(3) The facility shall be closed for the duration of the suspension.
(4) Where a license is withdrawn the dfacility shall cease to operate.

Section 32:
(1) A person whose medicine has been registered or exempted from registration under this Act shall report to the Authority, in the prescribed manner, any adverse reactions to the medicine.
(2) The following shall be reported to the Authority in the prescribed manner-
(a) any adverse reaction in a human to any registered medicine which report shall be made by the person with respect to whom the registration was granted;
(b) any adverse reaction in an animal to any medicine, which report shall be made by the person who administered the medicine;
(c) any adverse reaction in a human to any veterinary medicine ingested through eating an animal that was treated with a veterinary medicine, or was fed medicated feed; premix;
(d) any adverse reaction in a person to veterinary medicine through the handling of that medicine;
(e) lack of expected efficacy of a veterinary medicine or medicines used in humans, in relation to the indications claimed for the medicine; and
(f) any adverse reaction in an animal to a medicine used for humans where the use of that medicine in animals has been allowed.

Section 38 (extract):
(1) Medicines shall be classified according to the following classifications and descriptions, which shall be specified in the regulations-
(a) Schedule 1 medicine – a medicine which is or contains a prescribed psychotropic medicine, and must be kept under the control of a registered pharmacist, which medicines shall be further classified as follows-
(i) Schedule 1A medicine – a medicine which is highly liable to abuse and which may be dispensed only on written prescription, which prescription must be kept by the dispensing pharmacist for a minimum of three years;
(ii) Schedule 1B medicine – a medicine which is also liable to abuse though not as highly liable as a Schedule 1A medicine, and which may be dispensed only on written prescription;
(iii) Schedule 1C medicine – a medicine which, though widely used therapeutically, is liable to some but relatively minor, abuse in comparison with a Schedule 1A or a Schedule 1B medicine, and may be dispensed only on written prescription;
(iv) Schedule 1D medicine – a medicine which is unlikely to produce dependence or cause harm if misused, and may be dispensed without prescription;
(v) precursor chemical – a medicine which contains chemicals which are unlikely to cause harm or dependence, but are likely to be used in the manufacture of narcotic or psychotropic medicines;
(b) Schedule 2 medicine – a medicine, not being or containing a psychotropic medicine, or narcotic medicine which may be dispensed only on written prescription, and which must otherwise be kept in a pharmacy under the control of a registered pharmacist or in the case of veterinary medicine, a livestock advisory centre under the control of a paraprofessional;
(c) Schedule 3 medicine – a medicine which may be sold from a pharmacy without prescription, in the case of veterinary medicine, or sold from a livestock advisory centre without prescription; and
(d) Schedule 4 medicine – a medicine which may be sold over the counter by any licensed trader.
(2) The dispensing of Schedule 1A, Schedule 1B, Schedule 1C, Schedule 2 and Schedule 3 medicines, shall be by a pharmacist through a pharmacy, a livestock advisory centre or through an institution approved by the Director.

Section 39 (extract):
(1) A registered medical practitioner, dentist or veterinary surgeon may prescribe all medicines in the exercise of their professions.

Section 2 (extract):
“medicine” means-
...
(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 4 (extract):
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.

Section 23:
(1) No person shall-
(a) import;
(b) export;
(c) manufacture;
(d) distribute;
(e) sell;
(f) promote;
(g) advertise;
(h) store; or
(i) dispense,
any medicine or cosmetic, unless the medicine or cosmetic is registered by the Authority.

Section 37:
(1) A person in possession of unwanted medicine shall dispose of the medicine in the manner prescribed by regulations.
(2) In this section, “unwanted medicine” means a medicine which has expired, is substandard, banned, or is a counterfeit.

Section 50 (extract):
(1) A person who uses a veterinary medicinal product on an animal under his or her care or uses medicated feed to feed an animal that he or she keeps in a feed lot or other premises, shall ensure that the animal is not slaughtered for consumption before the prescribed withdrawal period has elapsed, and the prescribed maximum residue limit allowable in meat has fallen within the limit allowed.

Regulation 34 (extract):
(1) A person who disposes of medicines shall follow the guidelines and keep disposal certificates issued by the relevant authorities, for the Authority's inspection.
(2) The destruction of any Schedule 1A, Schedule 1B, Schedule 1C medicines or precursors, in part or whole, shall be reported to the Authority in accordance with the guidelines and, except where the desctruction is accidental, the destruction shall be supervised by a pharmacist and witnessed by a police officer.