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    CMDh meeting

    09.05.2017
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    Co-ordination Group for Mutual Recognition and Decentralised Procedures, Human (CMDh) was set up for the review of any issues related to marketing authorisations of medicinal products in two or more Member States in accordance with the mutual recognition procedure or decentralised procedure.

    This very broad scope for the CMDh is complemented by specific tasks laid down in the legislation: solving disagreements arising on the grounds of potential serious risk to public health between Member States involved in a mutual recognition or decentralised procedure; review of issues related to pharmacovigilance; review of issues related to variations; adopting on annual basis the list of medicinal products for which the harmonised summary of product characteristics should be drawn up.

    The CMDh is composed of one expert/representative from each National Competent Authority (plus Norway, Iceland and Liechtenstein). Member States may also appoint an alternate member with observers from the European Commission and EU accession countries attending the meetings.

    Read more about CMDh activities on the HMA website http://www.hma.eu/cmdh.html.

    During the Estonian presidency of the EU Council, a joint meeting with IT Directors will be held on 21-22 November 2017.