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

Type of law

The primary purpose of the rules for the production and distribution of veterinary medicinal products is the safeguarding of public health. This Directive lays down the Community code relating to veterinary medicinal products. The Directive consists of eleven Titles and three Annexes.
Title I lays down several definitions. Title II is devoted to defining the application scope of the present provisions, which shall apply to veterinary medicinal products intended to be placed on the market inter alia in the form of medicinal products, ready-made veterinary medicinal products or pre-mixes for medicated feeedingstuffs. Paragraph 2 of article 3 indicates the products which shall not fall within the application scope. Title III regards the marketing of veterinary medicinal products, for which a specific authorization issued by the competent authority of the Member State concerned shall be compulsory (art. 5). Article 12 specifies the documents and particulars which shall accompany the application to the authorization aforementioned. Member States shall take all appropriate measures to ensure that the procedure for granting an authorization to place a veterinary medicinal product on the market is completed within 210 days from the submission of a valid application (art. 21). The procedure described in Chapter 3 of Title III is to be followed. In order to facilitate the free movement of veterinary medicinal products within the Community, Chapter 4 provides for the mutual recognition of authorizations among Member States. To this end, a Committee for Veterinary Medicinal Products is established under article 31. Title IV regards manufacture and imports of veterinary medicinal products, for which an authorization is required too. Title V regulates with details labelling and packaging of veterinary medicinal products. Title VI makes provision in matter of possession, wholesale distribution and dispensing. With a view to encouraging the reporting to the competent authorities by Member States of suspected adverse reactions to veterinary medicinal products, Title VII provides for the establishment of a pharmacovigilance system. Title VIII regulates supervision and lays down sanctions. Annex I is concerned with requirements and analytical protocol, safety tests, pre-clinical and clinical for tests of veterinary medicinal products.
Date of text
Entry into force notes
This Directive came into force on 18 December 2001.
An unofficial consolidated version of the present Directive as amended last by Regulation (EC) No. 596/2009 of the European Parliament and of the Council of 18 June 2009 is attached.
Serial Imprint
Official Journal L 311, 28 November 2001, pp. 1-66.
Source language


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