Medicines (Data Sheets for Veterinary Drugs) Regulations 2000 (S.I. No. 2386 of 2000). Pays/Territoire Royaume-Uni Type du document Règlement Date 2000 Source FAO, FAOLEX Sujet Bétail Mot clé Santé des animaux Médicaments Collecte de données/déclarations Aire géographique Îles de l'Océan Atlantique, Europe, Europe et Asie Centrale, Atlantique Nord, Mer du Nord, Atlantique du Nord-Est, Europe du Nord Entry into force notes These Regulations enter into force on 1 October, 2000. Résumé These Regulations prescribe the form of data sheets (reg. 2) and the particulars to be contained in them (regs. 3 to 6 and the Schedule) which the holder of a product licence or marketing authorization is required under the Medicines Act 1968 to send or deliver to practitioners in connection with any advertisement or representation.. These Regulations enable documents which are summaries of the product characteristics to which a marketing authorization relates, containing the particulars prescribed by Article 5a of Council Directive 81/851/EC on the approximation of the laws of the Member States relating to veterinary medicinal products, to be used as data sheets for the purposes of advertisements and representations directed to practitioners in section 96 of the Medicines Act 1968. A "marketing authorization" is defined as one to which the Marketing authorizations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142) apply, being one which is granted pursuant to Council Directive 81/851/EC or one pursuant to Council Regulation (EC) No. 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Texte intégral Anglais Site web www.opsi.gov.uk 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 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