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10 April 2008

European Commission:
Implementation of the Advanced Therapies Regulation: public consultation on the revision of Annex I to Directive 2001/83/EC

Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008. The European Commission services have published on 13 December 2007 an implementation plan, outlining their priorities for the implementation of the Regulation. As part of this plan, the Commission intends to revise Part IV of Annex I to Directive 2001/83/EC in order to adapt it to the specificities of advanced therapy medicinal products. This public consultation document presents preliminary proposals to replace the existing Part IV of this Annex I.

Contributions to this public consultation should be sent by e-mail to, before 10 June 2008.

Read the summary outcome of the public consultation paper.