Export certificates for pharmaceutical factories and wholesales
View connections →Certificates of compliance with the GMP and the GDP for the export of a pharmaceutical factory or wholesale medicinal product
Published by: Fimea · Government organisation
Description language: English
Coverage: All Finland
About this service
Description
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.
How to use it
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
Conditions
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.
Where and how to get help
Certificates of a Pharmaceutical Product (CPP) · Website
Form and instructions for applying for an export certificates of pharmaceutical plants and wholesales
Description: English · Service languages: Swedish, English, Finnish
Check the official service page for current hours, exceptions, identification requirements and further contact details.