Regulation on modifications to the marketing authorization for veterinary medicinal products. Pays/Territoire Croatie Type du document Règlement Date 2010 Source FAO, FAOLEX Sujet Bétail Mot clé Santé des animaux Médicaments Autorisation/permis Questions de procédures Commerce intérieur Aire géographique Europe, Europe et Asie Centrale, Pays de l'Union Européenne, Méditerranée, Europe du Sud Entry into force notes This Regulation enters into force on the day of accession of the Republic of Croatia to the European Union. Résumé This Regulation establishes the procedure for modification or amendment of the previously granted marketing authorization for veterinary medicinal products, here in relation to the types and reasons of granted authorizations as listed in article 1, including the list of reference European Union documents and Directives. European Commission related guidelines are laid down in article 4. An application for the extension of a marketing authorization shall be assessed in accordance with the same procedure as for the initial marketing authorization to which it applies (article 17). Urgent safety restraints and related issues are listed in article 19. Modifications and/or procedures for additions to the marketing authorization for specific veterinary medicinal products are laid down in articles 20 and 21. Texte intégral Croate Site web www.nn.hr Références - Législation Implemente Law on veterinary medicinal products. Législation | Croatie | 2008 Mot clé: Santé des animaux, Législation de base, Médicaments, Autorisation/permis, Transport/dépôt, Transformation/manutention, Santé publique, Résidus, Monitorage, Inspection, Commerce intérieur, Commerce international, Infractions/sanctions, Vaccination Source: FAO, FAOLEX