Good Manufacturing Practice (GMP) is a set of principles and procedures followed in the manufacture and quality assurance of medicinal products to ensure the products meet all the requirements set for them in terms of production.
Fimea issues GMP certificates to Finnish medicinal product manufacturers and to competent authorities of export countries for the purpose of medicinal product exports (s ...
Issued in English, the certificates are in compliance with the Compilation of Community Procedures published by the European Medicines Agency. Certificates are issued in accordance with a valid medicinal product manufacturer's licence based on the most recent GMP inspection.
GMP certificate applications must contain the following information:
Medicinal product manufacturers can apply for a GMP certificate by emailing certificates@fimea.fi.