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

Materia

Ganado

Palabra clave

Subproductos animales Inspección Cuarentena Plagas/enfermedades Transporte/depósito Higiene/procedimientos sanitarios Sanidad animal Medicamentos

Área geográphica

Islas del Océano Atlántico, Europa, Europa y Central Asia, Atlántico Norte, Mar del Norte, Atlántico Nordeste, Europa Septentrional

Resumen

These Regulations implement Council Directive 93/40/EEC, which is the latest in a series of amendments to Council Directive 81/851/EEC. They provide for veterinary medicinal products to be placed on the market subject to marketing authorizations rather than the previous system of product licences. These authorizations may be granted either by the Ministers or, in accordance with Council Regulation 2309/93/EEC, by the European Agency for the Evaluation of Medicinal Products (reg. 3). They provide for the form and manner of an application, and the terms on which the Ministers may grant an authorization (regs. 4 and 5 and Schedules 1 and 2). They place duties on persons responsible for placing products on the market (reg. 6), on person where a product is manufactured outside the EEA (reg. 7) and on an importer who holds a marketing authorization (reg. 8). There are provisions for the variation, renewal, suspension and refusal of an authorization (regs. 9 to 13 and Schedule 3), provisions as to confidentiality (reg. 14) and fees (reg. 15). Breach of the regulations is an offence under regulation 16, with a defence in regulation 17.

Texto completo

Inglés

Página web

www.opsi.gov.uk

Referencias - Legislación

Implementa

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

Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.

Legislación | Unión Europea | 1981

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

Fuente: FAO, FAOLEX

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

Enmendado porr

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

Revocado por

Veterinary Medicines Regulations 2005 (S.I. No. 2745 of 2005).

Legislación | Reino Unido | 2005

Palabra clave: Sanidad animal, Medicamentos, Clasificación/declasificación, Inspección, Alimentos para animales/piensos

Fuente: FAO, FAOLEX