Welcome to the heads of medicines agencies website
This is the common website for the human and veterinary medicines authorities in Europe. The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. Read more
HMPWG Key documents list
26 November 2014, Rome (Italy)Human Stakeholders M...
HMA Procedures and Governance | pdffor the Permane...
Periodic Safety Update Reporting (PSUR) - Synchron...
CMDh Agendas & Minutes
CMDh Press Releases - 2015
Information on applications referred in accordance...
PAR for refused marketing authorisation applicatio...
CMDv GUI-27 Packaging ‘blue-box’ requirements in M... | PDF
Renewals | PDF
Email use between RMS & CMS during MRP/DCP and sta... | PDF
Best Practice Guide for the Repeat Use Procedure | PDF