Source: EURLEX
Language: en
Format: md

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| 3.4.2004 | EN | Official Journal of the European Union | CE 84/159 |

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(2004/C 84 E/0197)

WRITTEN QUESTION E-0082/04

by Proinsias De Rossa (PSE) to the Commission

(20 January 2004)

Subject:   Clinical Trials Directive

Further to the Commission's response to E-3209/03 and E-3215/03[(1)](#ntr1-CE2004084EN.01015901-E0001) on implementation of Directive 2001/20/EC[(2)](#ntr2-CE2004084EN.01015901-E0002), what views were presented by the Irish Government representatives at the 15 May 2003 pharmaceutical committee meeting? What progress has been made in the preparation of the implementation guidelines for this Directive in the Member States?

Answer given by Mr Liikanen on behalf of the Commission

(23 February 2004)

The Commission is currently working together with the Member States in the preparation of the implementing guidelines of this Directive. In this context, the Irish competent authority informed the Commission that specific guidance for the application of clinical trials will be developed and published soon.

The Commission discussed a first draft of the implementing guidelines with the Member States during the Standing Committee meeting held on 23 July 2003. No agreement could be reached during that meeting. The new draft for the implementing guidelines is still under discussion within the Commission.

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