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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)
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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.
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