BWA- QB – REGISTRATION
ANIMAL HEALTH
Botswana / Animal health
VETERINARY MEDICINAL PRODUCTS (VMPs)
REGISTRATION
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Section 25:
(1) The Authority shall maintain a register in which it shall record-
(a) the particulars of every medicine registered in terms of this Act, including the conditions, if any, subject to which that medicine has been registered; or
(b) the cancellation of the registration or variation of the conditions of registration of any medicine registered in terms of this Act.
(2) The register shall be open for inspection by the public at such times as may be determined by the Authority.
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Section 23 (extract):
(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.
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Section 24 (extract):
(1) An application for the registration of a medicine or cosmetic shall be submitted to the Authority in the prescribed form and shall be accompanied by the prescribed fee, and any further information that the Authority may consider necessary in order to process the application.
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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.
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Section 66:
(1) A person who contravenes the provisions of this Act or who-
(a) prescribes any Schedule 1 or Schedule 2 medicine without being authorised by this Act;
(b) obstructs or fails to comply with any reasonable request by the Authority, in the exercise of its functions under this Act
(c) otherwise contravenes the provisions of this Act for which a penalty is not provided, commits an offence and without prejudice to the person’s liability in terms of subsection (2), is liable to a fine of P10 000, or to a term of imprisonment not exceeding one year, or to both.
(2) Any person who imports, exports, manufactures, distributes, sells, dispenses, prescribes or advertises any medicine or other substance falsely purporting to be, or intended to or likely to induce anyone to a mistaken belief that it is a registered medicine, commits an offence and is liable to a fine of P100 000, or to imprisonment for 10 years, or to both.
(3) Where any person is convicted of an offence under this Act or any regulation made under it, the court may, at the request of the Authority, order any medicine or other substance in respect of which the offence was committed to be seized and disposed of as the Authority may require, and the Authority may at the same time withdraw any approval or authorisation previously given by the Authority to that person.