TITLE IIIPLACING ON THE MARKET
F1CHAPTER 4Mutual recognition procedure and decentralised procedure
Annotations:
Amendments (Textual)
F1Article 27
1
A coordination group shall be set up for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in this Chapter. The Agency shall provide the secretariat of this coordination group.
2
The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.
3
The coordination group shall draw up its own Rules of Procedure, which shall enter into force after a favourable opinion has been given by the Commission. These Rules of Procedure shall be made public.
Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.