Export certificates for pharmaceutical factories and wholesales
- Permit or other obligation
- 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 email@example.com
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.
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