Certificates of a Pharmaceutical Product

 

Fimea issues medicinal product manufacturers with Certificates of a Pharmaceutical Product (CPP) for export purposes. These certificates are issued for medicinal products intended for human or veterinary use that have been granted a marketing authorisation in Finland. CPP applications must be made using the form available on the Fimea website.

CPPs are issued by the Medicinal Products 1 process.

CPPs are subject to a charge, and the fee payable is determined in accordance with the Decree of the Ministry of Social Affairs and Health concerning activities of the Finnish Medicines Agency subject to fees No 66/2010. Fimea sends an invoice to the applicant in conjunction with the delivery of the CPP.

Applications can be submitted electronically to certificates@fimea.fi or on paper to Finnish Medicines Agency Fimea, PO Box 55, 00301 Helsinki, Finland.

Fimea recommends that CPP applications be sent electronically.

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