Revue Prescrire, article en une, Medicines in Europe: follow the calendar July 2004
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Medicines in Europe:
Implementing the legislation: follow the calendar
 
Patients, health professionals, consumers, health insurers and concerned politicians still have to ensure that the "competent authorities" fulfil their new obligations and make the pharmaceutical industry respect the legal framework that European society has chosen for it.
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The most important changes in the new legislation
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Medicines in Europe:
key campaigning points

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Directive 2004/27/EC, published on 30 April 2004, makes a number of changes to the previous Directive (2001/83/EC). It will not be applicable in individual Member States until it has been transposed into national legislation, which must be done by 30 October 2005 at the latest (article 3).

Regulation (EC) 726/2004, replacing Regulation 2309/93, applies immediately, without transposition, to all Member States. Nevertheless, some of its measures can be applied only when the 2004 Directive comes into effect.

Here are the application dates of the texts and their parts, and the corresponding measures:

20 May 2004: immediate application of the part of the 2004 Regulation relating to the functioning of the European medicines agency;

20 November 2004: the medicines agency's management board must rule on the application of European Regulation 1049/2001 (on public access to documents) to the agency;

30 October 2005: actual transposition of the 2004 Directive into national legislation by all Member States. This covers all items dealing with the authorisation and monitoring of medicines at the national level;

20 November 2005 : application of the rest of the 2004 Regulation; in particular, the centralised marketing procedure will become obligatory for four new therapeutic classes;

20 May 2008: the centralised marketing procedure will become obligatory for two further therapeutic classes;

No later than 2014: the European Commission must publish a general report on experience accumulated with the application of the new procedures.

©La revue Prescrire 1 July 2004