CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

Authorisation fees according to Ordinance 63/2015 (Portaria n° 63/215):
• Clinical trial Phase I-III: 1000 €
• Clinical trial Phase IV: 600 €
• Studies on Bioavailability and Bioequivalence: 350 €
• Substantial amendment to protocol: 200 €

INFARMED may grant exemption of fees when sponsors of clinical studies are non-profit institutions or in the case of clinical studies of non-commercial nature (Art 3, Portaria n.º 63/2015)

NB: Fees are being revised annually!

Waiver for academic (non-commercial) studies possible

Yes

Official guidance on required fees

Portaria nº63/2015 (Fee Ordinance)
Related information plus currently applicable Fee Ordinance (Portaria) is available on the INFARMED website in section Taxas (in Portuguese only).

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
Feedback