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

Materia

Ganado

Palabra clave

Sanidad animal Medicamentos Autorización/permiso Comercio internacional Inspección

Área geográphica

Alpes, Europa, Europa y Central Asia, Países de la Unión Europea, Mediterráneo, Europa Meridional

Resumen

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.

Texto completo

Italiano

Referencias - Legislación

Implementa

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

Legislación | Unión Europea | 1991

Palabra clave: Medicamentos, Autorización/permiso, Registro, Comercio interior, Comercio internacional, Sanidad animal, Procesamiento/manipulación

Fuente: FAO, FAOLEX