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Responsible for the service Finnish Medicines Agency Fimea

Export certificates for pharmaceutical factories and wholesales

  • Permit or other obligation
  • Nationwide
  • Public service

Upon request, Fimea will issue certificates to pharmaceutical factories supervised by Fimea on compliance with good manufacturing practices (GMP) and good distribution practices (GDP) to pharmaceutical wholesalers if Fimea has determined that they have been implemented during the inspection.

Do the following

The application form can be found on Fimea’s website. The request for a certificate is primarily sent by e-mail to certificates@fimea.fi

To whom and on what terms

Requires Fimea to perform and pass an inspection. As a rule, the holder of a marketing authorisation for a medicinal product can apply for an export certificate. However, the certificate may also be applied by a representative of the marketing authorisation holder, whose details must be included in the application. Export certificates shall be issued for medicinal products for human use or for animals that are authorised but not for active substances.

A fee is charged for the service.


Deadline

After inspection

Processing time

After inspection within 90 days, no deadline for subsequent certificates

Period of validity

Pharmaceutical factory certificate up to three years, pharmaceutical wholesale certificate up to five years

Basic information

The service is provided byFimea
Responsible for the serviceFimea
Area Whole Finland
Available languageEnglish
Text edited by: Finnish Medicines Agency Fimea
Updated: 4/13/2021