Retributions and taxes for clinical trial applications are payable in accordance with the 2022 FAMHP financing law (information available in Dutch or French).
- For non-commercial clinical trials, a fee exemption (zero fee) applies in Belgium.
- For commercial trials, detailed information on the applicable fees can be found on the page ‘Research and development’ (available in Dutch or French).
Invoicing
The retributions are payable only after an invoice has been issued by the FAMHP. Invoices are addressed exclusively to the sponsor. Each invoice will include the relevant information on the clinical trial, such as:
- the clinical trial number;
- the application ID;
- the sponsor and the designated legal representative;
- the application type;
- the submission date;
- the applicable fees.
Fee exemption for resubmissions due to CTIS technical issues
As of 1 January 2026, no invoice for CTR safety assessment and ethics committee assessment will be issued for resubmissions caused by CTIS‑related technical issues that occurred after validation, on the condition that the content of the submission package is identical to the validated submission package of the original submission.
After submitting your resubmission, you must request the fee exemption by sending an email to ct.rd@fagg-afmps.be with the subject line ‘xxxx-xxxxxx-xx-xx_resubmission_invoice_exemption’.
The e-mail should include:
- the application ID;
- a confirmation statement that the resubmission package is identical to the original one after validation (please mention the EU CT number, application ID and submission date of the original one), with no substantial, non‑substantial, or typographical changes. Only elements that must be updated for the new submission, such as study numbers, version numbers, and dates, should be adapted.
- evidence that the resubmission is due to CTIS technical issues, such as documentation that the original application was lapsed or withdrawn at the request of the EMA, accompanied by the corresponding EMA ticket mentioning the EU CT number, application ID and submission date and confirming the technical problem.
Resubmissions will be processed in the same way as the initial submission, meaning that the RFI will be re‑issued and responses will need to be resubmitted. This will of course depend on the exact moment of the bug throughout the application procedure.
This measure is not applicable for:
- bugs occurring before validation, as the original submission will not be charged;
- the GCP fee: as this fee is only being invoiced for authorised initial applications in Belgium, it will never be invoiced for a lapsed or withdrawn application. Consequently, this fee will still be invoiced for the resubmission if it concerns an authorised initial application in Belgium.