Article 85

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 · European Union

A Clinical Trials Coordination and Advisory Group (CTAG), composed of the national contact points referred to in Article 83 is hereby established. The CTAG shall have the following tasks: 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; to assist the Commission in providing the support referred to in the second paragraph of Article 84; to prepare recommendations on criteria regarding the selection of a reporting Member State. The CTAG shall be chaired by a representative of the Commission. 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. The secretariat shall be provided by the Commission. The CTAG shall draw up its rules of procedure. The rules of procedure shall be made public.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.