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

País/Territorio
Zambia
Tipo de documento
Reglamento
Fecha
2019
Fuente
FAO, FAOLEX
Fuente original
Statutory Instrument No. 79 of 2019
Materia
Ganado
Palabra clave
Medicamentos Sanidad animal Autorización/permiso Comercio interior Cuestiones de procedimiento Derechos/cánones Envasado/etiquetado Salud pública Registro
Área geográphica
Africa, Africa Oriental, Naciones en desarrollo sin litoral, Países menos desarrollados
Resumen

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.

Texto completo
Inglés
Página web
www.enotices.co.zm

Referencias - Legislación

Implementa

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

Legislación | Zambia | 2013

Palabra clave: Control de calidad de los alimentos/inocuidad de los alimentos, Aditivos alimentarios, Regímenes dietéticos especiales, Infracciones/sanciones, Sanidad animal, Medicamentos, Alimentos para animales/piensos, Institución, Plagas/enfermedades, Inspección, Comercio internacional, Autorización/permiso

Fuente: FAO, FAOLEX