Medicines legislation

GMP, GCP and IRIS guides

The guide for applicants and Marketing Authorization Holders (MAH) involved in GMP and GCP inspections coordinated by the EMA as well as the IRIS guide have been updated.Good Manufacturing Practices (GMP) are the principles and gu

Today is the rarest day of the year

Since its creation in 2008, Rare Disease Day has played a key role in building an international rare disease community working towards equality in terms of social opportunities, healthcare and access to diagnosis and therapies for