CMDh

E553862

European Union regulatory body coordination group medicines regulatory committee

CMDh is a European Medicines Agency coordination group that oversees and harmonizes the mutual recognition and decentralised procedures for authorising human medicines across EU member states.

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Statements (48)

Predicate	Object
instanceOf	European Union regulatory body ⓘ coordination group ⓘ medicines regulatory committee ⓘ
abbreviationOf	Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human NERFINISHED ⓘ
aim	to ensure consistent and harmonised decisions on nationally authorised medicines in the EU ⓘ to facilitate the functioning of the internal market for human medicines ⓘ
composition	representatives of EEA-EFTA states medicines agencies ⓘ representatives of EU Member States medicines agencies ⓘ
cooperatesWith	Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary NERFINISHED ⓘ Committee for Medicinal Products for Human Use NERFINISHED ⓘ Pharmacovigilance Risk Assessment Committee NERFINISHED ⓘ
country	Netherlands ⓘ
documentTypeProduced	best practice guides ⓘ guidance documents ⓘ public statements ⓘ questions and answers documents ⓘ
field	medicines regulation ⓘ pharmaceutical regulation ⓘ public health ⓘ
fullName	Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human NERFINISHED ⓘ
jurisdiction	European Union ⓘ
language	English ⓘ
location	Amsterdam NERFINISHED ⓘ
meetingFrequency	monthly ⓘ
memberType	one representative per EEA-EFTA state ⓘ one representative per EU Member State ⓘ
oversightArea	nationally authorised human medicines in the EU ⓘ
parentOrganization	European Medicines Agency NERFINISHED ⓘ
regulates	marketing authorisation of human medicinal products via MRP and DCP ⓘ
regulatoryProcedure	Decentralised Procedure ⓘ Mutual Recognition Procedure NERFINISHED ⓘ
responsibility	adoption of EU-wide positions on regulatory issues related to MRP and DCP ⓘ coordination of decentralised procedures for human medicines ⓘ coordination of mutual recognition procedures for human medicines ⓘ coordination of pharmacovigilance aspects related to nationally authorised products in MRP and DCP ⓘ coordination of referrals related to mutual recognition and decentralised procedures ⓘ coordination of renewals of marketing authorisations granted via MRP and DCP ⓘ coordination of variations to marketing authorisations granted via MRP and DCP ⓘ development of best practice for national competent authorities in MRP and DCP ⓘ harmonisation of marketing authorisations granted by EU Member States ⓘ issuing procedural guidance for mutual recognition and decentralised procedures ⓘ promotion of harmonised SmPC, labelling and package leaflet across Member States in MRP and DCP ⓘ publication of public statements and Q&A documents on regulatory procedures ⓘ resolution of disagreements between Member States in mutual recognition and decentralised procedures ⓘ
scope	human medicines ⓘ
website	https://www.ema.europa.eu/en/committees/co-ordination-group-mutual-recognition-decentralised-procedures-human-cmdh ⓘ
worksWith	European Commission NERFINISHED ⓘ Heads of Medicines Agencies NERFINISHED ⓘ

Referenced by (1)

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Coordination Group for Mutual Recognition and Decentralised Procedures – Human → abbreviation → CMDh ⓘ