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
HMA Procedures and Governance | pdffor the Permane...
Periodic Safety Update Reporting (PSUR) - Synchron...
15-17 July 2014, Rome (Italy): report | pdf
CTFG Activity Report
CTFG Activity Report 2008 ...
CMDh Agendas & Minutes
EMA/CMDh explanatory notes on Variation Applicatio...
List of substances under PSUR Work Sharing scheme ...
Core SmPC/PL -Hormone Replacement Therapy - Core P...
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