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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

article  85

CELEX:  02014R0536-20221205

Clinical Trials Coordination and Advisory Group
1. A Clinical Trials Coordination and Advisory Group (CTAG), composed of the national contact points referred to in Article 83 is hereby established.
2. The CTAG shall have the following tasks:
(a) to support the exchange of information between the Member States and the Commission on the experience acquired with regard to the implementation of this Regulation;
(b) to assist the Commission in providing the support referred to in the second paragraph of Article 84;
(c) to prepare recommendations on criteria regarding the selection of a reporting Member State.
3. The CTAG shall be chaired by a representative of the Commission.
4. The CTAG shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State. Any item of the agenda of the meeting shall be placed at the request of the Commission or a Member State.
5. The secretariat shall be provided by the Commission.
6. The CTAG shall draw up its rules of procedure. The rules of procedure shall be made public.