Certificates of a Pharmaceutical Product (CPP)

Guide to completing your application:

1. To be completed by Fimea.
2. Please use, wherever possible, International Nonproprietary Names (INN) or names of the European Pharmacopoeia * You may add the trade name used in the requesting country in the section marked Additional information. If you choose to provide a trade name, please ensure it is also displayed in your export certificate request, for example in the e-mail message.
3. Please enter details of complete composition here or in an appendix.
4. Export certificates are only issued for pharmaceutical products, which have a marketing authorisation.
5. Please include the official English translation of the approved Finnish Summary of Product Characteristics (SPC). English SPCs approved during the marketing authorisation process by Fimea can also be used.
6. Permission for releasing the export certificate must be obtained from the marketing authorisation holder. The applicant is responsible for presenting this to the authorities.

Export certificates are issued on human and veterinary medicinal products but not active ingredients.

Applications are primarily submitted to Fimea electronically at certificates[at]fimea.fi

or, in exceptional cases, by post to:

Finnish Medicines Agency Fimea

P.O. Box 55

00034 FIMEA

Applications for export certificates should primarily be submitted by the marketing authorisation holder. However, applications can also be submitted by a representative of the marketing authorisation holder, provided that their full details are included in the application.

Export certificates are issued for human and veterinary medicinal products on the following basis:

- Trade name (trade name approved for the Finnish market only), marketing authorisation number, the date marketing authorisation was issued/renewed.

- Composition (full composition or active ingredient(s) only). The information on composition must include amounts per unit.

- Marketing authorisation holder, manufacturer and manufacturer responsible for the finished product, including address details.

- Summary of Product Characteristics (SPC), this must be the latest valid SPC approved by Fimea and also be provided in an English translation carried out by a licensed translator. Where products have undergone the mutual recognition procedure, the English translation approved during the authorisation process can also be used.

- Applicants should provide all details they wish to have included in the export certificate. Any blank fields should be marked accordingly in order to prevent them from being completed at a later stage.

The application should be submitted to Fimea either electronically or as a paper version. Please indicate the requesting country and number of certificates required. Fimea recommends that you submit your application electronically. If any of the details provided are incorrect, you will be asked to amend the application. A signed export certificate will be sent to you in the post. CPP is valid until the conditions written into CPP are unchanged including possible attachments (Summary of Product Characteristics, Package Leaflet).