Certificates of a Pharmaceutical Product

 

Fimea issues marketing authorisation holders with Certificates of a Pharmaceutical Product (CPP) for export purposes (generally outside the EU/EEA). 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.

CPP guidance is based on the Guidelines on the implementation of the WHO certification scheme.

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. 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, 00034 FIMEA, Finland.

Fimea recommends that CPP applications be sent electronically.

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