CAAmendment object

Authorisation mandatory for

All clinical investigations requiring authorisation by CA
Any substantial amendments to the study protocol
Authorisation mandatory for: All clinical trials approved by Infarmed and CEIC (National Ethics Committee); Change in MD – Infarmed; Change in inclusion/exclusion criteria – Infarmed & CEIC

Responsible for submission of SA

Sponsor
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

Standard notification form

Standard Notification form to be used by the applicant is the same as used for IMP studies and is provided on the INFARMED website in section Medicamentos Uso Humano> Ensaios Clinicos> Formulários:
“Substantial Amendment Notification Form (pdf)”/ “Formulário de pedido de alteração (pdf)”

Applicable national legal framework/ Reference

Art 4, Deliberação n.º 514/2010, de 3 de Março
Art 18 Law 21/2014 (pt)

Additional Information

Substantial amendments shall be simultaneously notified to the competent EC and the national CA.

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