CMDh is the Coordination Group for Mutual Recognition and Decentralised Procedures – Human. It examines questions relating to marketing authorisations involving two or more EU Member States and has statutory responsibilities that include pharmacovigilance matters.
Why a pharmacovigilance professional uses it
CMDh materials are relevant when safety issues affect nationally authorised products, particularly where harmonised action across Member States is required. The CMDh website also provides procedural documents, positions, recommendations and links to national competent-authority activity.
CMDh should be read alongside PRAC and EMA materials because the bodies perform different but interacting functions within the European regulatory network.