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Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019

Country/Territory
Zambia
Document type
Regulation
Date
2019
Source
FAO, FAOLEX
Original source
Statutory Instrument No. 79 of 2019
Subject
Livestock
Keyword
Drugs Animal health Authorization/permit Internal trade Procedural matters Royalties/fees Packaging/labelling Public health Registration
Geographical area
Africa, Eastern Africa, Landlocked Developing Nations, Least Developed Countries
Abstract

These Regulations concern medicines and allied substances (marketing authorisation of medicines). It provides that a person who intends to place a medicine on the market shall apply to the Authority for a marketing authorisation in Form I set out in the Schedule on payment of the fee set out in the Medicines and Allied Substances (Fees) Regulations, 2016. A person may sell or supply veterinary medicine under the following categories: (a) prescription only medicine - veterinary; (b) pharmacy medicine veterinary; and (c) general sale medicine veterinary. A holder of a marketing authorisation shall label the primary package or container of a medicine to show, for instance, the indications and directions for use, including the target species in case of veterinary medicine, and a statement “For Veterinary Use Only”, amongst other things. An original container of a medicine shall be accompanied by a package insert printed in legible letters in English stating, among others, the indications, in case of a veterinary medicine, specifying target species; dosage and directions for use, in case of a veterinary medicine, specific to each target species; and precautions and warnings, including withdrawal periods, in case of a veterinary medicine used in food producing animals.

Full text
English
Website
www.enotices.co.zm

References - Legislation

Implements

Medicines and Allied Substances Act, 2013 (No. 3 of 2013).

Legislation | Zambia | 2013

Keyword: Food quality control/food safety, Food additives, Special dietary uses, Offences/penalties, Animal health, Drugs, Animal feed/feedstuffs, Institution, Pests/diseases, Inspection, International trade, Authorization/permit

Source: FAO, FAOLEX