GMP certificates

 

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 (section 85 of the Medicines Act).

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.

Medicinal product manufacturers can apply for a GMP certificate by emailing certificates@fimea.fi.

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.

For more information contact:

In GMP compliance monitoring and inspection issues:
Eija Pelkonen, Director, Supervision and licences, phone +358 2952 23200
Eeva Leinonen, Head of Unit, phone +358 2952 23220
Anne Junttonen, Senior Pharmaceutical Officer, phone +358 2952 23219

In GMP certificate issues:
Kari Lönnberg, Senior Inspector, phone Tel. +358 29 522 3232

The email address format is firstname.surname@fimea.fi.