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Ministerial Decree implementing Directive 91/412/CEE of the Commission on the production of veterinary drugs.

Pays/Territoire
Italie
Type du document
Règlement
Date
1993
Source
FAO, FAOLEX
Source d'origine
Gazzetta Ufficiale della Repubblica Italiana No. 149, 28 June 1994, pp. 1-23.
Sujet
Bétail
Mot clé
Santé des animaux Médicaments Autorisation/permis Commerce international Inspection
Aire géographique
Alpes, Europe, Europe et Asie Centrale, Pays de l'Union Européenne, Méditerranée, Europe du Sud
Résumé

The Decree establishes the process for the production of veterinary drugs subject to the authorization, as per Title II of Legislative Decree of 27 January 1992, No. 119, in order to assure the compliance with the appropriate quality standards. The proper implementation of the provisions of the present Decree is under the surveillance of the Ministry of Health, in charge of carrying out periodical inspections every three years. Technical rules governing the production of veterinary drugs concern, inter alia, the training of the personnel, the enforcement of hygiene programmes within the factory, the keeping of the required documentation by the manufacturer, the checks during every production phase, and the establishment of a quality control service, tor the purpose of carrying out tests and analyses on raw materials, materials used for the preparation of the drugs, by-products and final products.

Texte intégral
Italien

Références - Législation

Implemente

Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

Législation | Union européenne | 1991

Mot clé: Médicaments, Autorisation/permis, Enregistrement, Commerce intérieur, Commerce international, Santé des animaux, Transformation/manutention

Source: FAO, FAOLEX