Commission Directive 99/104/EC amending the Annex to Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products.

Materia

Ganado

Palabra clave

Sanidad animal Medicamentos

Área geográphica

Pays de l'Union Européenne

Entry into force notes

This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

Resumen

The Annex to Directive 81/852/EC is amended by the Annex of this Directive. The new Annex establishes that the applicant must demonstrate that the veterinary medical product is manufactured in accordance with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products and its updates, published by the European Commission in Volume 7 of its publication "The rules governing medicinal products in the European Union".

Texto completo

Inglés

Página web

europa.eu

Referencias - Legislación

Enmienda

Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products.

Legislación | Unión Europea | 1981

Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Comercio interior, Alimentos para animales/piensos

Fuente: FAO, FAOLEX

Implementado por

Veterinary medicinal products (Presentation and content of license applications forms) Regulations 2002 (P.I. 200/2002).

Legislación | Chipre | 2002

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

Fuente: FAO, FAOLEX

Arrêté du 24 janvier 2001 portant application de la directive 1999/104/CE de la Commission du 22 décembre 1999 et modifiant l'arrêté du 5 septembre 1994 fixant les normes et protocoles applicables aux essais analytiques, toxicologiques, pharmacologiques et cliniques en matière d'essais de médicaments vétérinaires.

Legislación | Francia | 2001

Palabra clave: Normas, Medicamentos, Sanidad animal

Fuente: FAO, FAOLEX