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Commission Directive 2000/37/EC amending Chapter VIa 'Pharmacovigilance' of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.

Pays/Territoire
Union européenne
Type du document
Législation
Date
2000
Source
FAO, FAOLEX
Source d'origine
Official Journal L 139, 10 June 2000, pp. 25-27.
Sujet
Bétail
Mot clé
Santé des animaux Médicaments Autorisation/permis Accès-à-l'information Collecte de données/déclarations Commerce intérieur Commerce international
Aire géographique
Países de la Unión Europea
Entry into force notes
This Directive came into force on 30 June 2000.
Résumé

The present Directive lays down some amendments to Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products, and precisely to Chapter VIa of such Directive, which deals with the pharmacovigilance system and which has been added by Directive 93/40/EEC. In order to ensure the adoption of appropriate regulatory decisions concerning the veterinary medicinal products authorized within the Community, the Member States shall establish a veterinary pharmacovogilance system. This sytem shall be used to collect information useful in the surveillance of veterinary medicinal products, taking into particular account adverse reactions in animals and in human beings. The marketing authorization holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country. New article 42f, contained in article 1 (6) of this Directive, provides for the setting-up of a data-processing network.

Texte intégral
Anglais
Site web
europa.eu

Références - Législation

Amende

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

Implementé par

Legislative Decree No. 71 implementing Directives 2000/37/EC and 2001/82/EC concerning veterinary medicinal products.

Législation | Italie | 2003

Mot clé: Santé des animaux, Médicaments

Source: FAO, FAOLEX