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 network ⓘ
oversees decentralised procedures for human medicines ⓘ
mutual recognition procedures for human medicines ⓘ
parentBody 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 (8)

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 → worksWith → Coordination Group for Mutual Recognition and Decentralised Procedures – Human ⓘ
HMA → hasWorkingGroup → Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human ⓘ
linked to: Coordination 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 ⓘ
PRAC → worksWith → Coordination Group for Mutual Recognition and Decentralised Procedures – Human ⓘ
CMDh → fullName → Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human ⓘ
linked to: Coordination Group for Mutual Recognition and Decentralised Procedures – Human
CMDh → abbreviationOf → Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human ⓘ
linked to: Coordination Group for Mutual Recognition and Decentralised Procedures – Human
CMDv → relatedOrganization → Coordination Group for Mutual Recognition and Decentralised Procedures – Human ⓘ