CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

Clinical Trial applications:
Clinical trials 212 000 ISK (approx. €1425.-)
Substantial amendments: 96 000 (approx. €645.-)
Bioavailability study: 70 000 (approx. €470.-)
In case of a need for external experts hired by the IMA: additional costs apply

In exceptional circumstances the fee for clinical trials can be waived if there is a valid rationale for doing so as in academic trials.

Waiver for academic (non-commercial) studies possible

Yes

Payment requirements (timelines)

After receipt of invoice

Official guidance on required fees available

Yes

Official guidance on required fees

Related information is available on the IMA website in section Home > IMA > Fees

Applicable national legal framework/ Reference

Annex 1, TARIFF No. 635/2011 for marketing authorisations, annual fees and other licence fees for medicinal products and related products, collected by the Icelandic Medicines Agency

Additional Information

Waiver for academic trials: There are no waive forms, but is has to be requested in the application and justification provided for the waiver.

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