Submission of substantial amendments
The sponsor must request to the Competent Ethics Committee (CEC) the substantial amendment of the protocol or of any other document that may have impact in the safety or well-being of the study subjects and/or that modifies the conduct of the study. The clinical study can only proceed with the favorable opinion of the CEC. This committee issues their opinion within 20 working days from the date of the request.
In interventional studies with the use of cosmetics, and in accordance with Law no. 21/2014, of april 16, the Competent Ethics Committee (CEC) is the Ethics Commitee for Health (CES), unless CEIC has to appoint a local Ethics Committee for Health (CES) where a CES does not exist.
In interventional clinical studies of cosmetics, the sponsor also needs to notify INFARMED, I.P. of the reasons and content of the proposed amendments.
All relevant documentation should be submitted via RNEC, as provided in the "Technical and Functional Specifications", in accordance with article 10 of Ordinance no. 65/2015, of march 5.