Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 Pays/Territoire Zambie Type du document Règlement Date 2019 Source FAO, FAOLEX Source d'origine Statutory Instrument No. 79 of 2019 Sujet Bétail Mot clé Médicaments Santé des animaux Autorisation/permis Commerce intérieur Questions de procédures Royalties/redevances Emballage/étiquetage Santé publique Enregistrement Aire géographique Afrique, Afrique Orientale, Nations en développement sans littoral, Pays les moins avances Résumé 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. Texte intégral Anglais Site web www.enotices.co.zm Références - Législation Implemente Medicines and Allied Substances Act, 2013 (No. 3 of 2013). Législation | Zambie | 2013 Mot clé: Contrôle de qualité alimentaire/innocuité des produits alimentaires, Additifs alimentaires, Aliments diététiques et de régime, Infractions/sanctions, Santé des animaux, Médicaments, Aliments pour animaux, Institution, Parasites/maladies, Inspection, Commerce international, Autorisation/permis Source: FAO, FAOLEX