For medicines to reach the EU market, they must be registered. The European medicines regulatory system is based on a network of national human and veterinary medicines agencies from the EU Member States and the European Economic Area, the European Commission and the European Medicines Agency (EMA).

The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) was set up by the Directive of the European Parliament and of the Council on the Community code relating to medicinal products for human use. It aims to examine questions relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The tasks of the CMDh were substantially extended in 2012 as regards pharmacovigilance.

The CMDh started its activities in November 2005, replacing the informal Mutual Recognition Facilitation Group (MRFG), which was in operation for over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.

This very broad scope for the CMDh is complemented by specific tasks laid down in the legislation:

• the aim of solving disagreements on the grounds of potential serious risk to public health between the Member States involved in a mutual recognition or decentralised procedure;
• the examination of questions related to pharmacovigilance.

The CMDh is composed of one representative for each Member State and Norway, Iceland and Liechtenstein, appointed for a renewable period of three years.

CMDh website: http://www.hma.eu/cmdh.html