Regulation 2004/726 - Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency - Main contents

official title

 

Legal instrument	Regulation
Number legal act	Regulation 2004/726
Original proposal	COM(2001)404
CELEX number i	32004R0726

Avis juridique important

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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)

Official Journal L 136 , 30/04/2004 P. 0001 - 0033

Regulation (EC) No 726/2004 of the European Parliament and of the Council

of 31 March 2004

laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

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 from the Commission(1),

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

After consulting the Committee of the Regions,

In accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

• (1) 

  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(4) provides that, within six years of the entry into force of the Regulation, the Commission is to publish a general report on the experience acquired as a result of the operation of the procedures laid down in the Regulation.

• (2) 

  In the light of the Commission's report on the experience gained, it has proved necessary to improve the operation of the authorisation procedures for the placing of medicinal products on the market in the Community and to amend certain administrative aspects of the European Agency for the Evaluation of Medicinal Products. In addition, the name of that Agency should be simplified and changed to the European Medicines Agency, (hereinafter referred to as the "Agency").

• (3) 

  It emerges from the conclusions of that report that the amendments to be made to the centralised procedure set up by Regulation (EEC) No 2309/93 consist of corrections to some of the operating procedures and adaptations to take account of the probable development of science and technology and the future enlargement of the European Union. It also emerges from the report that the general principles previously established which govern the centralised procedure should be maintained.

• (4) 

  Moreover, since the European Parliament and the Council have adopted Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use(5) and Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products(6), all the references to the codified Directives in Regulation (EEC) No 2309/93 should be updated.

• (5) 

  For the sake of clarity, it is necessary to replace the said Regulation with a new Regulation.

• (6) 

  It is appropriate to preserve the Community mechanism set up by the repealed Community legislation for concertation prior to any national decision relating to a high-technology medicinal product.

• (7) 

  Experience gained since the adoption of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology(7) has shown that it is necessary to create a centralised authorisation procedure that is compulsory for high-technology medicinal products, particularly those resulting from biotechnical processes, in order to maintain the high level of scientific evaluation of these medicinal products in the European Union and thus to preserve the confidence of patients and the medical...

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