CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

Fees for the authorization of
• MD without CE marking or with CE marking for other indication: 600,00 €
• MD with CE marking: 400,00 €
• Substantial amendment to protocol: 200,00 €

NB! Status 2015 - Fees are being revised annually

Academic Studies: No submission fees.

Waiver for academic (non-commercial) studies possible

Yes

Applicable national legal framework/ Reference

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
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