Directive 1981/851 - Approximation of the laws of the Member States relating to veterinary medicinal products - Main contents

official title

 

Legal instrument	Directive
Number legal act	Directive 1981/851
Original proposal	COM(1976)189
CELEX number i	31981L0851

Avis juridique important

|

Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products

Official Journal L 317 , 06/11/1981 P. 0001 - 0015

Finnish special edition: Chapter 13 Volume 11 P. 0182

Spanish special edition: Chapter 13 Volume 12 P. 0003

Swedish special edition: Chapter 13 Volume 11 P. 0182

Portuguese special edition Chapter 13 Volume 12 P. 0003

COUNCIL DIRECTIVE of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (81/851/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

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

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

Whereas, 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 ; whereas this results in the hindering of trade in medicinal products within the Community, thereby directly affecting the establishment and functioning of the common market;

Whereas such hindrances must, accordingly, be removed ; whereas this entails approximation of the relevant provisions;

Whereas the provisions of this Directive which concern veterinary medicinal products are, although appropriate, not adequate for veterinary medicinal products used to confer active immunity, to diagnose the state of immunity and to confer passive immunity or for medicinal products based on radioactive isotopes ; whereas it is therefore advisable not to prescribe their application to such products for the present;

Whereas medicated feedingstuffs do not come within the scope of this Directive ; whereas, however, it is necessary, for both public health and economic reasons, to prohibit the use of unauthorized medicinal products in the manufacture of medicated feedingstuffs;

Whereas marketing authorization shall be refused where a medicinal product lacks therapeutic effect or where there is insufficient proof of such effect ; whereas the concept of therapeutic effect must be understood as being the effect promised by the manufacturers;

Whereas such authorization shall also be refused where the withdrawal period indicated is not long enough to eliminate health hazards arising from residues;

• (1) 

  OJ No C 152, 5.7.1976, p. 1. (2) OJ No C 293, 13.12.1976, p. 64. (3) OJ No C 299, 18.12.1976, p. 12. Whereas, in order gradually to achieve freedom of movement of veterinary medicinal products, the granting of marketing authorizations in several Member States for the same medicinal product should be made easier;

Whereas, for this purpose, a Committee for Veterinary Medicinal Products, composed of representatives of the Member States and of the Commission, should be set up and should be responsible for giving an opinion on whether a particular veterinary medicinal product complies with the requirements set out in this Directive;

Whereas this Directive is only one stage in the achievement of the aim of freedom of movement of veterinary medicinal products ; whereas, for this purpose, new measures will prove necessary, in the light of experience gained - especially within the said Committee - for the removal of the remaining barriers to freedom of movement;

Whereas, in order to facilitate the movement of veterinary medicinal products and to prevent the...

This text has been adopted from EUR-Lex.

This page is also available in a full version containing the legal context, de Europese rechtsgrond, other dossiers related to the dossier at hand and the related cases of the European Court of Justice.