Fees for clinical trials of medicinal products

Application fee

According to the Ordinance (2010:1176) on fees for the state control of medicinal products (in Swedish Förordning om avgifter för den statliga kontrollen av läkemedel), applicants conducting clinical trials must pay an application fee. The fee contributes to financing the processing of the application and the Swedish Medical Products Agency’s supervision of the clinical trials.

Medicinal products for human use

* Of which 16 000 SEK refers to the Swedish Ethical Review Authority’s processing
** Of which 2 000 SEK refers to the Swedish Ethical Review Authority’s processing

Medicinal products for animal use

Please note

• For a clinical trial application to become valid, a document with invoice details must be attached to the application/uploaded under “Proof of payment” in the Clinical Trials Information System (CITIS).
• When an application is deemed valid, an invoice will be sent to the applicant.
• The invoice must be paid even if an application for a fee reduction has been submitted.
• If a fee reduction is granted, a refund of all or part of the fee will be issued.
• In case of resubmission, the application fee must be paid again.

Invoice documentation for clinical trials

Fee reduction for clinical trials

The Swedish MPA may grant a reduction of fee if there are exceptional reasons. If the applicant would like to apply for a reduction of the fee, the grounds for such reduction must be justified and should be clearly stated in the cover letter when submitting the clinical trial application.

No advance notices regarding whether the fee may be reduced or not will be given by the MPA, the applications will be assessed on a case by case basis. The applicant should be aware that the processing of the application is initiated regardless of whether the reduction of fee is granted or not and presuppose that the entire fee should be paid when the application has been submitted. This applies both for initial applications and resubmissions.