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.
After receipt of invoice
Related information is available on the IMA website in section Home > IMA > Fees
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
Waiver for academic trials: There are no waive forms, but is has to be requested in the application and justification provided for the waiver.