CMDh

E553862

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.

All labels observed (1)

Label Occurrences
CMDh canonical 1

How this entity was disambiguated

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 ⓘ
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 ⓘ
Committee for Medicinal Products for Human Use ⓘ
Pharmacovigilance Risk Assessment Committee ⓘ
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 ⓘ
jurisdiction European Union ⓘ
language English ⓘ
location Amsterdam ⓘ
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 ⓘ
regulates marketing authorisation of human medicinal products via MRP and DCP ⓘ
regulatoryProcedure Decentralised Procedure ⓘ
Mutual Recognition Procedure ⓘ
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 ⓘ
Heads of Medicines Agencies ⓘ

How these facts were elicited

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.