CRED ERP 25

The CMDh As the name implies, this is a coordination group set up for the examination of any question relating to marketing authorisations of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The task of the CMDh was substantially extended in 2012 by Directive 2010/84/EU, amending Directive 2001/83/EC as regards to pharmacovigilance as CMDh has to take binding decisions on PRAC recommendations on PSUSAs/PASS and safety referrals (article 31 and 107i). The group may also identify issues that may need to be raised to the European Commission, Heads of Medicines Agency (HMA), or other interested parties as needed. Specific processes and procedures followed by CMDh are listed on their website for further consideration (https://www.hma.eu/human-medicines/cmdh.html). This group is an independent coordination group that provides a forum between the parties on among others resolving MRP issues; further escalation may occur to the CHMP for final resolution or closure of the procedure in case no consensus can be reached between the RMS and CMSs (see also CMDh website). There are various sub-groups that are held within the CMDh including: • Working Group on Active Substance Master File Procedures • Working Party on Variation Regulation • Working Party on Pharmacovigilance Work Sharing Procedures (PhVig WSP WP) • CTS (Communication Tracking System) Working Group • Joint CMDh/GCP Inspectors Working Party • Non-Prescription Medicinal Products Task Force