Europe – CMDh Rules of Procedure

Article 27 of Directive 2001/83/EC of the European Parliament and of the Council on the Union code relating to medicinal products for human use as amended establishes the coordination group for examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States. Any question related to marketing authorisations of medicinal products in two or more Member States covers a variety of issues related to new applications, variations, renewals and pharmacovigilance activities. According to Article 27 para.3 of Directive 2001/83/EC, 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…