Ministerial Decree implementing Directive 91/412/CEE of the Commission on the production of veterinary drugs. Country/Territory Italy Document type Regulation Date 1993 Source FAO, FAOLEX Original source Gazzetta Ufficiale della Repubblica Italiana No. 149, 28 June 1994, pp. 1-23. Subject Livestock Keyword Animal health Drugs Authorization/permit International trade Inspection Geographical area Alps, Europe, Europe and Central Asia, European Union Countries, Mediterranean, Southern Europe Abstract 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. Full text Italian References - Legislation Implements Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Legislation | European Union | 1991 Keyword: Drugs, Authorization/permit, Registration, Internal trade, International trade, Animal health, Processing/handling Source: FAO, FAOLEX