Directive 2001/82 - EC code relating to veterinary medicinal products - Main contents

official title

 

Legal instrument	Directive
Number legal act	Directive 2001/82
Original proposal	COM(1999)213
CELEX number i	32001L0082

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Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products

Official Journal L 311 , 28/11/2001 P. 0001 - 0066

Directive 2001/82/EC of the European Parliament and of the Council

of 6 November 2001

on the Community code relating to veterinary medicinal products

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee(1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

Whereas:

• (1) 

  Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products(3), Council Directive 81/852/EEC of 28 September 1981 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(4), Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products(5), and Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products(6) have been frequently and substantially amended; in the interests of clarity and rationality, the said Directives should therefore be codified by assembling them in a single text.

• (2) 

  The primary purpose of any rules for the production and distribution of veterinary medicinal products must be the safeguarding of public health.

• (3) 

  However, this objective must be achieved by means which will not hinder the development of industry and trade in medicinal products within the Community.

• (4) 

  In so far as the Member States already have certain provisions laid down by law, regulation or administrative action governing veterinary medicinal products, such provisions differ in essential principles. This results in the hindering of trade in medicinal products within the Community, thereby directly affecting the functioning of the internal market.

• (5) 

  Such hindrances must, accordingly, be removed; whereas this entails approximation of the relevant provisions.

• (6) 

  It is necessary from the point of view of public health and the free movement of veterinary medicinal products for the competent authorities to have at their disposal all useful information on authorized veterinary medicinal products in the form of approved summaries of the characteristics of products.

• (7) 

  With the exception of those medicinal products which are subject to the centralised Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(7), a marketing authorization in one Member State ought to be recognized by the competent authority of the other Member States unless there are serious grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health, or to the environment; in the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific...

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