Directive 2004/28 - Amendment of Directive 2001/82/EC on the EC code relating to veterinary medicinal products - Main contents

official title

 

Legal instrument	Directive
Number legal act	Directive 2004/28
Original proposal	COM(2001)404
CELEX number i	32004L0028

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Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (Text with EEA relevance)

Official Journal L 136 , 30/04/2004 P. 0058 - 0084

Directive 2004/28/EC of the European Parliament and of the Council

of 31 March 2004

amending Directive 2001/82/EC 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 and Article 152(4)(b) thereof,

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

Having regard to the Opinion of the European Economic and Social Committee(2),

After consulting the Committee of the Regions,

Acting in accordance with the procedure referred to in Article 251 of the Treaty(3),

Whereas:

• (1) 

  Directive 2001/82/EC of the European Parliament and of the Council of 23 October 2001 on the Community code relating to veterinary medicinal products(4) codified and consolidated previous Community legislation on veterinary medicinal products in a single text in the interests of clarity and rationalisation.

• (2) 

  The Community legislation so far adopted has made a major contribution to the achievement of the objective of free and safe movement of veterinary medicinal products and the elimination of obstacles to trade in such products. However, in the light of the experience gained, it has become clear that new measures are necessary to eliminate the remaining obstacles to free movement.

• (3) 

  It is therefore necessary to align national laws, regulations and administrative provisions that contain differences with regard to the basic principles in order to promote the operation of the internal market without adversely affecting public health.

• (4) 

  The main purpose of any regulation on the manufacture and distribution of veterinary medicinal products should be to safeguard animal health and welfare as well as public health. The legislation on marketing authorisations for veterinary medicinal products, and the criteria governing the granting of authorisations, are such as to strengthen the protection of public health. That aim should, however, be achieved by means that do not hinder the development of the pharmaceutical industry or trade in veterinary medicinal products within the Community.

• (5) 

  Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions.

• (6) 

  In the light of the Commission's report on the experience acquired, it has proved necessary to improve the operation of the marketing authorisation procedures for veterinary medicinal products in the Community.

• (7) 

  Particularly as a result of scientific and technical progress in the field of animal health, the definitions and scope of Directive 2001/82/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of veterinary medicinal products. In order to take account both of the emergence of new therapies and of the growing number of so-called "borderline" products between the medicinal product sector and other sectors, the definition of "medicinal product" should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may...

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