How to Submit a Substantial Amendment Notification
After the beginning of a clinical trial the sponsor may make amendments to the protocol, or make other changes. Amendments to the trial are regarded as 'substantial' where they are likely to have a significant impact on the safety or physical or mental integrity of the clinical trial participants, and/or on the scientific value of the trial. Such amendments require authorization from INFARMED, I.P. and/or a favourable opinion from CEIC.
The submission of a substantial amendment notification through RNEC is only possible if it regards to a clinical trial that was submitted through this portal.
All substantial amendment notifications regarding clinical trials that were not submitted to INFARMED, IP and CEIC via RNEC, should be done independently, and if applicable, to these two entities, according to instructions to the applicants available at INFARMED and CEIC websites.
Applicable Regulation:
- Law no. 21/2014, of 16th April, modified by Law no. 73/2015, of 27th July
- Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (CT-1)
- Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use (CT-2)
Applicable Forms:
Substantial Amendment Notification Form
