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.

Materia

Ganado

Palabra clave

Sanidad animal Medicamentos Autorización/permiso Comercio interior Alimentos para animales/piensos

Área geográphica

Pays de l'Union Européenne

Resumen

Member States shall take all appropriate measures to ensure that the particulars and documents which shall accompany applications for authorization to place a veterinary medicinal product on the market, pursuant article 5 of Directive 81/851/EC, are submitted by the persons concerned in accordance with the Annex to this Directive. The Annex is divided in 3 parts: analytical (physico-chemical, biological or microbiological) tests of veterinary medicinal products (I), toxicological and pharmacological tests (II), clinical trials (III). (4 articles and 1 Annex).

Texto completo

Inglés

Página web

europa.eu

Referencias - Legislación

Implementado por

Legislative Decree No. 119 implementing Directives Nos. 81/851/CEE, No. 81/852/CEE, No. 87/20/CEE and No. 90/676/CEE on veterinary drugs.

Legislación | Italia | 1992 (1997)

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

Fuente: FAO, FAOLEX

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

Marketing Authorisations for Veterinary Medicinal Products Amendment Regulations 2000 (S.I. No. 776 of 2000).

Legislación | Reino Unido | 2000

Palabra clave: Subproductos animales, Inspección, Cuarentena, Plagas/enfermedades, Transporte/depósito, Higiene/procedimientos sanitarios, Sanidad animal

Fuente: FAO, FAOLEX

Animal Remedies Regulations, 1996.

Legislación | Irlanda | 1996

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

Fuente: FAO, FAOLEX

Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. No. 3142 of 1994).

Legislación | Reino Unido | 1994

Palabra clave: Subproductos animales, Inspección, Cuarentena, Plagas/enfermedades, Transporte/depósito, Higiene/procedimientos sanitarios, Sanidad animal, Medicamentos

Fuente: FAO, FAOLEX

Enmendado porr

Council Directive 93/40/EEC amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.

Legislación | Unión Europea | 1993

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

Fuente: FAO, FAOLEX

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.

Legislación | Unión Europea | 1999

Palabra clave: Sanidad animal, Medicamentos

Fuente: FAO, FAOLEX

Revocado por

Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products.

Legislación | Unión Europea | 2001

Palabra clave: Legislación básica, Sanidad animal, Medicamentos, Autorización/permiso, Recopilación de datos/informes, Acceso-a-la-información, Inspección, Comercio interior, Comercio internacional, Infracciones/sanciones

Fuente: FAO, FAOLEX