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