Submission of substantial amendments
The sponsor shall notify the Member State, within one week, whenever it intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation and/or that changes the conduct of the study, the reasons for and the nature of those modifications.
In Portugal, the reasons for and the nature of those modifications, as well as all relevant documentation, shall be submitted to INFARMED, I.P., which will liaise with the CEIC. The submission must be made in electronic format, at the time, through the RNEC.
Substantial modifications to clinical investigations follow the terms provided for in Article 75 of Regulation (EU) 2017/745, and can be implement to clinical investigations at the earliest 38 days after notification, unless INFARMED, I.P. identify grounds for refusal (article 71(4)) or on considerations of public health, subject and user safety or health, of public policy, or a negative ethical opinion has been issued. Under national law, the implementation of changes in PT requires a favourable opinion from the CEIC.