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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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
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