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...
Compassionate use program
16 - 18 February 2016, Amsterdam (Netherlands)HMA ...
Periodic Safety Update Reporting (PSUR) - Synchron...
Pharmacovigilance Legislation [Track version] (Jul...
Mock-ups, Specimens and Samples for new applicatio...
Added in April 2016
25 April 2016
NEW - April 20...
Requirements on submissions (number and format) fo...
Technical guidance Human and Vet (19/10/2015)
User Guide for the electronic application form for...
January – February 2016