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Issuance of Export and GMP Certificates

The National Agency for Medicines (NAM) issues certificates concerning pharmaceutical products and active pharmaceutical ingredients and their manufacturer requested by exporting pharmaceutical companies and by the authorities of the importing country (Medicines Act, article 85).

The Marketing Authorisation department of the NAM issues Export Certificates (CPP, Certificate of a Pharmaceutical Product) for pharmaceutical products with marketing authorisation in Finland meant for human or veterinary use. 

The Inspectorate issues GMP (Good Manufacturing Practice) Certificates. 

Applications for such certificates are made separately to the departments in question. The combined CPP and GMP certificates will not be issued after 31.5.2007.

The CPP and GMP Certificates are issued in English. Applicants must state the country for which the application is sought when they apply. Issued certificates are numbered.

There is a charge for certificates and the price is based on the decree of the Ministry of Social Affairs and Health concerning activities of the NAM subject to fees. The NAM will invoice the applicant in connection with delivery of the certificate.

Applying for CPP Certificates
Applying for GMP Certificates

Updated 24.4.2007