CAAmendment object

Authorisation mandatory for

All clinical trials requiring authorisation by CA
All clinical trials approved by INFARMED and CEIC (National Ethics Committee); Change in IMP – INFARMED; Change in inclusion/exclusion criteria – INFARMED & CEIC; Change in Recruiting sites, Informed consent - CEIC

Responsible for submission of SA

Sponsor
Substantial Amendment Notification Form - Cf. Sec. 3.7.b of Detailed guidance on request to competent authorities for authorisation of clinical trial on a medicinal product for human use, notification of substantial amendments & declaration of trial end

Standard notification form

European “Substantial Amendment Notification Form”/"Formulário de pedido de alteração": provided on the INFARMED website in section Medicamentos Uso Humano> Ensaios Clinicos> Formulários:

Guidance on submission of SA available

Yes

Guidance on submission of SA

Substantial Amendment Notification Form - Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)

Applicable national legal framework/ Reference

Art 18 Law 21/2014 (pt), amended by Law 73/2015

Additional Information

Submission to INFARMED and CEIC are simultaneous at RNEC.

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