Applying for a GMP certificate
- Permit or other obligation
- Nationwide
- Public service
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 ...
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How to apply for a certificate
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:
- whether the certificate is requested for the manufacture of medicinal products for human or veterinary use;
- if there is more than one manufacturing site, the site for which site the certificate is requested must be specified;
- the number of GMP certificates required;
- the export countries for which the certificates are requested;
- contact details and invoicing and delivery address.
Medicinal product manufacturers can apply for a GMP certificate by emailing certificates@fimea.fi.