ZMB- QF - PHARMACOVIGILANCE AND RECALL
ANIMAL HEALTH
Zambia / Animal health
VETERINARY MEDICINAL PRODUCTS (VMPs)
PHARMACOVIGILANCE AND RECALL
questions
1 answer
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16(1); A person who wishes to renew a marketing authorization shall apply to the Authority at least one hundred and eighty days before the expiry of the marketing authorization in Form XIII set out in the Schedule on payment of a prescribed fee. (2) An application for renewal of marketing authorization shall be accompanied by- (a) a consolidated report of any amendments made to the marketing authorization, including adverse drug reaction reports and safety updates.
2 answers
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17(3); The Authority shall, where it is established that the holder of a permit stocks veterinary medicines or products under insanitary conditions, direct the holder to dispose of the medicines or products at the holder's cost.
46(1); The Authority may, where it determines that it is not in public interest that any medicine or allied substance should be made available to the public, by notice in the Gazette, direct that person to return the medicine or allied substance which the person has in that person's possession to- (a) the manufacturer of the medicine or allied substance; (b) in case of any imported medicine or allied substance, to the importer concerned; (c) deliver it or send it to the Authority or such other person as the Authority may determine.
2 answers
document title
text/abstract
17(3); The Authority shall, where it is established that the holder of a permit stocks veterinary medicines or products under insanitary conditions, direct the holder to dispose of the medicines or products at the holder's cost.
46(1); The Authority may, where it determines that it is not in public interest that any medicine or allied substance should be made available to the public, by notice in the Gazette, direct that person to return the medicine or allied substance which the person has in that person's possession to- (a) the manufacturer of the medicine or allied substance; (b) in case of any imported medicine or allied substance, to the importer concerned; (c) deliver it or send it to the Authority or such other person as the Authority may determine.
1 answer
document title
text/abstract
46 (4); A person who contravenes subsection (3), concerning the sale of any product subject to recall or withdrawal, commits an offence and is liable, upon conviction, to a fine not exceeding one million penalty units or to imprisonment for a period not exceeding three years, or to both.
60; A person who contravenes subsection (1) commits an offence and is liable, upon conviction, to a fine not exceeding one million penalty units or to imprisonment for a period not exceeding three years, or to both. In addition to the penalty provided for in subsection (2), the court before which a person is convicted of an offence under this section may order that the medicines or allied substances in respect of which the offence is committed be forfeited to the State to be destroyed