Coordination group for Mutual recognition and Decentralised Procedures - CMDh

Coordination group for Mutual recognition and Decentralised Procedures - CMDh

Poster

Lora Petrova1, Emil Hristov1, Kalina Andreevska1, Iva Parvova2
1Faculty of Chemistry and Pharmacy, Sofia University "Saint Kliment Ohridski", Bulgaria
2Clinic of Rheumatology, Department of Rheumatology, Medical University - Sofia

Aim: To define the role of the CMDh- Coordination group for Mutual Recognition and Decentralised Procedures regarding the resolution of emerging disagreements between Member States participating in the Mutual Recognition Procedure (MRP) or Decentralised Procedure (DCP). Materials and methods: We performed documentary analysis of the specific tasks of the CMDh, defined in the legislation. Results and discussion: The Coordination group for Mutual recognition and Decentralised Procedures (CMDh) was established in 2005 with Directive 2004/27/EC, replacing the Mutual Recognition Facilitation Group (MRFG). The CMDh deals with any question related to the marketing authorisation of a medicinal product in two or more Member States in accordance with the MRP and DCP, as well as on variation to these marketing authorisations. In 2012 its purpose was substantially extended by Directive 2010/84/EU regarding pharmacovigilance. The group consists of one representative from an EU member state (including Norway, Iceland and Liechtenstein).The Coordination group considers points of disagreement raised by Member States during the MRP or DCP in relation to the assessment report, the summary of product characteristics, labelling, the package leaflet and packaging of the medicinal product for reasons related to a potential serious risk to public health. The CMDh aims to reach an agreement within 60 days. Conclusion: The Coordination group encourages and supports the early identification of scientific disagreements between Member States involved in MRP or DCP, as well as variations in the marketing authorisation to ensure easy and rapid access to medicinal products for all patients in the European Union. Keywords: Coordination group, Mutual recognition procedure, Decentralised procedure