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Decree-Law No. 148/2008 transposing Directives 2001/82/EC of the EU Parliament and the Council of 6 November on the Community Code relating to veterinary medicinal products into national law.

País/Territorio
Portugal
Tipo de documento
Legislación
Fecha
2008
Fuente
FAO, FAOLEX
Fuente original
Diário da República, I Série, No. 145, 29 July 2008.
Materia
Ganado
Palabra clave
Sanidad animal Higiene/procedimientos sanitarios Medicamentos Envasado/etiquetado Comercio interior Comercio internacional
Área geográphica
Europa, Europa y Central Asia, Países de la Unión Europea, Atlántico Norte, Atlántico Nordeste, Europa Meridional
Entry into force notes
This Decree-Law enters into force 60 days after its publication.
Resumen

This Decree-Law partially transposes Directive 2001/82/EC of the European Parliament and the Council of 6 November on the Community code relating to veterinary medicinal products. The purpose of this Decree-Law is also to ensure the implementation and enforcement in the national legislation of the obligations arising from Commission Regulation (EC) No. 1084/2003 of 3 June on the examination of changes to the terms of authorizations for the placing on the market of medicinal products for human use and veterinary medicinal products granted by the competent authorities of the Member States in respect of veterinary medicinal products. This Decree-Law establishes the legal regime governing the marketing authorization (MAH) including its amendments and renewals, manufacture, import, export, distribution, marketing, labelling and information, advertising , control on drugs, possession and use of veterinary medicinal products, including, in particular, medical pre-mixtures, immunological, homeopathic and herbal veterinary products and medicinal gases. Without prejudice to Article 92, this Decree-law shall apply to veterinary medicinal products prepared industrially or in manufactured through an industrial process. It also applies to active substances used as raw materials in accordance with Article 41 and the arrangements laid down in Community legislation on veterinary products by the European Union.

Texto completo
Portugués
Página web
dre.pt

Referencias - Legislación

Implementa

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

Revoca

Decree-Law No. 232/99 regulating production, trade, storage, transport and use of veterinary drugs.

Legislación | Portugal | 1999

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

Fuente: FAO, FAOLEX

Decree-Law No. 184/97 regulating the authorization for trade, production and use of animal drugs.

Legislación | Portugal | 1997

Palabra clave: Medicamentos, Sanidad animal, Comercio internacional

Fuente: FAO, FAOLEX

Decree-Law No. 245/2000 regulating production, import/export and use of veterinary immunological medicinal product.

Legislación | Portugal | 2000

Palabra clave: Higiene/procedimientos sanitarios, Sanidad animal, Institución, Comercio internacional, Medicamentos

Fuente: FAO, FAOLEX