Notification of conclusion and final report
The notification of the conclusion of a clinical study with cosmetics must be sent by the sponsor to CEC and to INFARMED, I.P., within 90 days from the date of completion of the participation of the last subject of the study.
Whenever a clinical study is concluded earlier, the sponsor must notify CEC and Infarmed within 15 days and clarify the reasons of this earlier conclusion.
The investigator or the sponsor provides the final results of the clinical study as clinical study final report, publications or presentations.
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.