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.

Subject

Livestock

Keyword

Animal health Hygiene/sanitary procedures Drugs Packaging/labelling Internal trade International trade

Geographical area

Europe, Europe and Central Asia, European Union Countries, North Atlantic, North-East Atlantic, Southern Europe

Entry into force notes

This Decree-Law enters into force 60 days after its publication.

Abstract

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.

Full text

Portuguese

Website

dre.pt

References - Legislation

Implements

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

Legislation | European Union | 2001

Keyword: Basic legislation, Animal health, Drugs, Authorization/permit, Data collection/reporting, Access-to-information, Inspection, Internal trade, International trade, Offences/penalties

Source: FAO, FAOLEX

Repeals

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

Legislation | Portugal | 1999

Keyword: Drugs, International trade, Animal health, Transport/storage, Authorization/permit

Source: FAO, FAOLEX

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

Legislation | Portugal | 1997

Keyword: Drugs, Animal health, International trade

Source: FAO, FAOLEX

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

Legislation | Portugal | 2000

Keyword: Hygiene/sanitary procedures, Animal health, Institution, International trade, Drugs

Source: FAO, FAOLEX