This content is exclusively provided by FAO / FAOLEX

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.

Type of law

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.
Date of text
Entry into force notes
This Decree-Law enters into force 60 days after its publication.
This Decree-Law repeals the following: Decree-Law No. 146/97 of 11 de June; Decree-Law No. 185/2004 of 29 July and Decree-Law No. 175/2005 of 25 October.
Serial Imprint
Di rio da Rep blica, I S rie, No. 145, 29 July 2008.
Source language


Legislation Amendment
Original title
Decreto-Lei n. 148/2008 - Transp e para a ordem jur dica interna a Directiva n. 2004/28/CE, do Parlamento Europeu e do Conselho, de 31 de Mar o, e parcialmente a Directiva n. 2001/82/CE, do Parlamento Europeu e do Conselho, de 6 de Novembro, que estabelece um c digo comunit rio relativo aos medicamentos veterin rios(...).