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 meeting with Interested Parties - 18 November...
Active Substance Master File [Track version] (Apri...
PSUR Work Sharing - Other guidance documents
Information Sharing Pilot for the Evaluation of G...
Recommendations for classification of unforeseen v...
CMDv GUI-27 Packaging ‘blue-box’ requirements in M... | PDF
October-November | PDF
CMDv DDPS declaration (pilot) | PDF