Veterinary Medicinal Products Regulations, 2004 (L.N. 469 of 2004). Pays/Territoire Malte Type du document Règlement Date 2004 Source FAO, FAOLEX Sujet Bétail Mot clé Santé des animaux Médicaments Autorisation/permis Collecte de données/déclarations Accès-à-l'information Inspection Commerce intérieur Commerce international Infractions/sanctions Aire géographique Europe, Europe et Asie Centrale, Pays de l'Union Européenne, Méditerranée, Europe du Sud Résumé In compliance with the European Community code relating to veterinary medicinal products laid down in Directive 2001/82/EC, the present Regulations establish particular provisions applicable to veterinary medicinal products destined to be placed on the market in the form of medicinal products, readymade veterinary medicinal products or premixes for medicated feedingstuffs. Title III (regs. 5-37) deals with marketing, for which an authorization issued by the Veterinary Services is compulsory. Title IV (regs. 38-50) concerns manufacture and imports. Title V (regs. 51-57) deals with labelling and package insert. Title VI (regs. 58-64) applies to the possession, wholesale distribution and dispensing of veterinary medicinal products. Title VII (regs. 65-71) provides for the setting up of a pharmocovigilance system. Title VIII (regs. 72-79) regards the inspections to be carried out by the Veterinary Services with a view to ensuring compliance with these Regulations, and sets out the sanctions to be applied in case of infringement. The Schedule attached concerns the requirements and analytical protocol, safety tests, pre-clinical and clinical for tests of veterinary medicinal products. Texte intégral Anglais Site web www.doi.gov.mt Références - Législation Implemente Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products. Législation | Union européenne | 2001 Mot clé: Législation de base, Santé des animaux, Médicaments, Autorisation/permis, Collecte de données/déclarations, Accès-à-l'information, Inspection, Commerce intérieur, Commerce international, Infractions/sanctions Source: FAO, FAOLEX Implementé par Veterinary Medicinal Products (Amendment) (No. 2) Regulations (L.N. 360 of 2009). Législation | Malte | 2009 Mot clé: Médicaments, Santé des animaux, Inspection Source: FAO, FAOLEX Amendé par Veterinary Medicinal Products (Amendment) (No. 2) Regulations, 2009 (L.N. 360 of 2009). Législation | Malte | 2009 Mot clé: Médicaments, Santé des animaux, Normes, Inspection Source: FAO, FAOLEX Veterinary Medicinal Products (Amendment) Regulations, 2009 (L.N. 23 of 2009). Législation | Malte | 2009 Mot clé: Santé des animaux, Médicaments, Autorisation/permis, Commerce intérieur, Commerce international Source: FAO, FAOLEX Veterinary Medicinal Products (Amendment) Regulations, 2006 (L.N. 82 of 2006). Législation | Malte | 2006 Mot clé: Santé des animaux, Médicaments, Autorisation/permis, Commerce intérieur, Commerce international Source: FAO, FAOLEX Veterinary Medicinal Products (Amendment No. 2) Regulations, 2021 (L.N. 470 of 2021). Législation | Malte | 2021 Mot clé: Santé des animaux, Médicaments, Infractions/sanctions Source: FAO, FAOLEX Veterinary Medicinal Products (Amendment) Regulations, 2021 (L.N. 179 of 2021). Législation | Malte | 2021 Mot clé: Santé des animaux, Médicaments, Autorisation/permis, Collecte de données/déclarations, Accès-à-l'information, Inspection, Commerce intérieur, Commerce international, Infractions/sanctions Source: FAO, FAOLEX