BWA- QF - PHARMACOVIGILANCE AND RECALL
ANIMAL HEALTH
Botswana / Animal health
VETERINARY MEDICINAL PRODUCTS (VMPs)
PHARMACOVIGILANCE AND RECALL
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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 57 (extract):
(2) Where there is any adverse reaction to a medicine that is being used in a clinical trial or medical research, the licence holder shall report the adverse reaction to the Authority, in the prescribed manner.
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Section 24 (extract):
(5) Where the holder of market authorisation is aware of a safety, efficacy or quality problem which could have detrimental effects on public health, the holder of the market authorisation shall, in consultation with the Authority, recall the medicine or cosmetic.
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Section 24 (extract):
(7) The Authority may, without prior consultation from the holder of market authorisation, recall a medicine or cosmetic.
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Section 24 (extract):
(6) Any person who contravenes subsection (5) commits an offence and is liable to a fine not exceeding P100 000 and to imprisonment not exceeding 10 years, or to both.
Section 66 (extract):
(1) A person who contravenes the provisions of this Act or who-
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(b) obstructs or fails to comply with any reasonable request by the Authority, in the exercise of its functions under this Act
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(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.