Coordination Group for Mutual Recognition and Decentralised Procedures – Human

E130564

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) is a European regulatory body that coordinates and oversees the mutual recognition and decentralised approval of human medicines across EU member states.

All labels observed (2)

How this entity was disambiguated

Statements (48)

Predicate Object
instanceOf European Union regulatory body
coordination group
medicines regulatory body
abbreviation CMDh
abbreviationOfCounterpart CMDv
aimsTo harmonise the approval of human medicines across EU Member States
resolve disagreements between Member States in mutual recognition and decentralised procedures
benefits patients in the European Union
pharmaceutical companies seeking multi-state authorisation
collaboratesWith Committee for Medicinal Products for Human Use
European Commission
composedOf representatives of EEA-EFTA states
representatives of EU Member States
coordinates decentralised procedures for human medicines
mutual recognition procedures for human medicines
ensures consistent application of EU pharmaceutical legislation in MRP and DCP
establishedFor coordination of non-centralised EU marketing authorisation routes
focusesOn coordination of decentralised marketing authorisation procedures
mutual recognition of national marketing authorisations
hasCounterpart Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary
issues guidance on decentralised procedures
guidance on mutual recognition procedures
jurisdiction European Economic Area
European Union
language English
locatedIn European Union
meets regularly according to an annual work plan
memberOf European medicines regulatory authorities
surface form: European medicines regulatory network
oversees decentralised procedures for human medicines
mutual recognition procedures for human medicines
parentBody Heads of Medicines Agencies
surface form: Heads of Medicines Agencies network
publishes lists of ongoing and finalised procedures
procedural advice for applicants
regulates marketing authorisation procedures for human medicines
regulatoryProcessStage post-centralised authorisation alternatives
regulatoryScope human medicines
sector pharmaceuticals
public health
subjectArea marketing authorisation of medicines
pharmaceutical regulation
supports implementation of EU pharmaceutical legislation
topic coordination of regulatory decisions among Member States
mutual recognition of benefit–risk evaluations of medicines
typeOfProcedureHandled Decentralised Procedure
Mutual Recognition Procedure
website https://www.hma.eu/cmdh.html
worksWith European Medicines Agency
national competent authorities of EU Member States

How these facts were elicited

Referenced by (4)

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

Heads of Medicines Agencies hasCommittee Coordination Group for Mutual Recognition and Decentralised Procedures – Human
Pharmacovigilance Risk Assessment Committee within the European Medicines Agency worksWith Coordination Group for Mutual Recognition and Decentralised Procedures – Human
subject surface form: Pharmacovigilance Risk Assessment Committee
HMA hasWorkingGroup Coordination Group for Mutual Recognition and Decentralised Procedures – Human
this entity surface form: Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human
Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary hasCounterpart Coordination Group for Mutual Recognition and Decentralised Procedures – Human