CMDh: Co-ordination Group for Mutual Recognition and Decentralised Procedures

The CMDh is established by Article 27 of Directive 2001/83/EC. Each Member State appoints one representative, with Iceland, Liechtenstein and Norway taking part through the EEA Agreement, and the European Medicines Agency provides the secretariat. The group meets monthly at EMA and takes decisions by consensus where it can. Its original task was to examine questions about the authorisation of a medicine in two or more Member States under the mutual recognition and decentralised procedures, and that remains its core role.

Under Article 29(3) the CMDh has 60 days to resolve a disagreement where a concerned member state objects to an assessment on grounds of potential serious risk to public health. If it fails, the matter goes to the CHMP. Since the 2012 pharmacovigilance legislation the group also adopts positions on PSUR single assessments and safety referrals for nationally authorised products under Articles 107g and 107k. A position agreed by consensus is implemented directly by the Member States; a majority position goes to the Commission for a decision.

Beyond procedures, the CMDh publishes the practical rules that applicants rely on every day: best practice guides on the decentralised, mutual recognition and repeat-use procedures, question and answer documents on variations and renewals, the product information templates and the annex of national Blue Box requirements, and the published Article 5 classification recommendations. Its monthly press releases and meeting minutes signal changes in practice before formal guidance appears.

What goes wrong: applicants who prepare a decentralised procedure without reading the current best practice guide and find that timetables, submission formats or document expectations have moved; companies that treat a CMDh position on a PSUR single assessment as advisory when it is binding; and teams that miss a published Article 5 recommendation and file a change in the wrong category. The group also settles practical questions that the legislation leaves open, such as how to handle a reference member state that can no longer act, how to run a procedure when a concerned member state withdraws, and which documents a repeat-use application must contain, so a team that works only from the Directive will be working from an incomplete rulebook.