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.

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.