Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. No. 3142 of 1994). Pays/Territoire Royaume-Uni Type du document Règlement Date 1994 Source FAO, FAOLEX Sujet Bétail Mot clé Sous-produits animaux Inspection Quarantaine Parasites/maladies Transport/dépôt Hygiène/procédures sanitaires Santé des animaux Médicaments Aire géographique Îles de l'Océan Atlantique, Europe, Europe et Asie Centrale, Atlantique Nord, Mer du Nord, Atlantique du Nord-Est, Europe du Nord Résumé These Regulations implement Council Directive 93/40/EEC, which is the latest in a series of amendments to Council Directive 81/851/EEC. They provide for veterinary medicinal products to be placed on the market subject to marketing authorizations rather than the previous system of product licences. These authorizations may be granted either by the Ministers or, in accordance with Council Regulation 2309/93/EEC, by the European Agency for the Evaluation of Medicinal Products (reg. 3). They provide for the form and manner of an application, and the terms on which the Ministers may grant an authorization (regs. 4 and 5 and Schedules 1 and 2). They place duties on persons responsible for placing products on the market (reg. 6), on person where a product is manufactured outside the EEA (reg. 7) and on an importer who holds a marketing authorization (reg. 8). There are provisions for the variation, renewal, suspension and refusal of an authorization (regs. 9 to 13 and Schedule 3), provisions as to confidentiality (reg. 14) and fees (reg. 15). Breach of the regulations is an offence under regulation 16, with a defence in regulation 17. Texte intégral Anglais Site web www.opsi.gov.uk Références - Législation Implemente Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products. Législation | Union européenne | 1981 Mot clé: Santé des animaux, Médicaments, Autorisation/permis, Commerce intérieur, Aliments pour animaux Source: FAO, FAOLEX 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 Council Directive 93/40/EEC amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products. Législation | Union européenne | 1993 Mot clé: Médicaments, Autorisation/permis, Enregistrement, Commerce intérieur, Commerce international, Santé des animaux Source: FAO, FAOLEX Amendé par Marketing Authorisations for Veterinary Medicinal Products Amendment Regulations 2000 (S.I. No. 776 of 2000). Législation | Royaume-Uni | 2000 Mot clé: Sous-produits animaux, Inspection, Quarantaine, Parasites/maladies, Transport/dépôt, Hygiène/procédures sanitaires, Santé des animaux Source: FAO, FAOLEX Abrogé par Veterinary Medicines Regulations 2005 (S.I. No. 2745 of 2005). Législation | Royaume-Uni | 2005 Mot clé: Santé des animaux, Médicaments, Classement/déclassement, Inspection, Aliments pour animaux Source: FAO, FAOLEX