Keeping Product Authorisations Up-To-Date 

MAHs for nationally authorised products, in particular those authorised by the mutual recognition (MR) and decentralised procedures (DCP), are recommended to continually monitor the Co-ordination Group for Mutual Recognition and Decentralised Procedures-human (CMDh) website in relation to their product portfolio, in particular the press release and minutes. MAHs should then take required actions according to the requested timeframe. 

The Co-ordination Group for Mutual Recognition and Decentralised Procedures-human (CMDh) was established under 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. The role of the CMDh is to examine any questions relating to a marketing authorisation of a medicinal product in two or more Member States. These questions cover issues relating to new applications, variations, renewals, pharmacovigilance activities and other issues arising. The CMDh holds monthly meetings, which are attended by representatives of the EU/EEA member states to discuss and resolve arising issues. Outcomes of these meetings are published in the CMDh press release every month. The press releases are published on their website immediately after the meeting. The CMDh publishes detailed minutes of the meetings approximately two months later. The minutes are elaborated further in ‘procedural guidance’, ‘advice to MAHs’ and the ‘recently published history’ sections of their website. Therefore, MAHs should regularly review the resources on the CMDh website and act accordingly.