Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Pays/Territoire Union européenne Type du document Législation Date 1991 Source FAO, FAOLEX Source d'origine CELEX-EUR Official Journal L 228, 17 August 1991, pp. 70-73. Sujet Bétail Mot clé Médicaments Autorisation/permis Enregistrement Commerce intérieur Commerce international Santé des animaux Transformation/manutention Aire géographique Países de la Unión Europea Résumé This Directive lays down the principles and guidelines of good manufacturing practice for veterinary medicinal products whose manufacture requires the authorization referred to in article 24 of Directive 81/851/EC. The manufacturers shall ensure that the manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorization. The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different services involved. At each manufacturing site, the manufacturer shall have competent and appropriately qualified personnel. Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations. Texte intégral Anglais Site web europa.eu Références - Législation Implemente Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products. Législation | Union européenne | 1981 Mot clé: Médicaments, Autorisation/permis, Enregistrement, Commerce intérieur, Commerce international, Santé des animaux, Institution Source: FAO, FAOLEX Implementé par Decree No. 6 of 2006 containing rules relative to veterinary medicinal products. Législation | Pays-Bas | 2005 Mot clé: Maladie des poissons, Santé des animaux, Médicaments, Commerce intérieur, Commerce international, Enregistrement Source: FAO, FAOLEX Ministerial Joint Decree No. 313314 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Législation | Grèce | 1994 Mot clé: Production animale, Médicaments, Inspection, Santé des animaux Source: FAO, FAOLEX Veterinary Medicines Regulations 2011 (S.I. No. 2159 of 2011). Législation | Royaume-Uni | 2011 Mot clé: Maladie des poissons, Aliments pour animaux, Santé des animaux, Médicaments, Institution, Autorisation/permis, Résidus, Inspection, Commerce international, Infractions/sanctions Source: FAO, FAOLEX Ministerial Decree implementing Directive 91/412/CEE of the Commission on the production of veterinary drugs. Législation | Italie | 1993 Mot clé: Santé des animaux, Médicaments, Autorisation/permis, Commerce international, Inspection Source: FAO, FAOLEX Animal Remedies Regulations, 1996. Législation | Irlande | 1996 Mot clé: Santé des animaux, Médicaments, Autorisation/permis, Commerce intérieur, Commerce international, Inspection Source: FAO, FAOLEX Veterinary Medicines Regulations 2013 (S.I. No. 2033 of 2013). Législation | Royaume-Uni | 2013 Mot clé: Maladie des poissons, Aliments pour animaux, Santé des animaux, Médicaments, Institution, Autorisation/permis, Résidus, Inspection, Commerce international, Infractions/sanctions Source: FAO, FAOLEX Good Manufacturing Practice for Veterinary Medicinal Products Rules, 2018 (L.N. 3 of 2018). Législation | Malte | 2018 Mot clé: Médicaments, Santé des animaux, Autorisation/permis, Inspection Source: FAO, FAOLEX Cabinet Regulation No. 319 of 2007 on Manufacture and Control of Veterinary Medicinal Products, the Procedure for the Issuance of a Good Manufacturing Practice Certificate to a Manufacturer of Veterinary Medicinal Products and Regarding the Requirements for the Qualification and Professional Experience of the Official Responsible for the Manufacture of Veterinary Medicinal Products Législation | Lettonie | 2007 (2011) Mot clé: Médicaments, Santé des animaux, Certification, Commerce/industrie/sociétés Source: FAO, FAOLEX Décision no 2015-03-076 du 11 mars 2015 relative aux bonnes pratiques de fabrication des médicaments vétérinaires Législation | France | 2015 (2017) Mot clé: Médicaments, Santé des animaux, Commerce intérieur, Autorisation/permis, Hygiène/procédures sanitaires, Transport/dépôt, Fraude, Inspection, Commerce international Source: FAO, FAOLEX