Request to conduct a clinical study of cosmetics
Law no. 21/2014, of april 16, provides the creation of National Database of Clinical Studies (RNEC), which will have features regarding the electronic submission of clinical studies with the use of cosmetic products.
According to article 34 of the abovementioned law, it is required the previous notification to INFARMED, I.P. of the interventional clinical studies conducted with cosmetic products.
The request for an opinion to the Competent Ethics Committee (CEC) and the notification to Infarmed, under article 34, can be submitted simultaneously, according to an instruction that will be disclosed.
Clinical studies of cosmetics can be started 30 days after the request for an opinion to the Competent Ethics Committee, unless within that period Infarmed issues a decision unfavorable to its realization.
The sponsor of the clinical study with the intervention of cosmetics must submit the following documentation:
- Application for conducting a clinical study with the intervention of cosmetics;
- Clinical investigation protocol/plan;
- Investigator's brochure;
- Informed consent;
- Proof of insurance;
- Labelling and instructions for use;
- The opinion of the Competent Ethics Committee (if available at the time of submission);
- Up to date CV/resume of the principal investigator of each center;
- Payment guide and receipt of the fee. Or, alternatively, proof of exemption from the fee, in accordance with the provisions of article 3 of Ordinance no. 63/2015, of march 5.
All relevant documentation must be submitted via RNEC, as provided in the document "Technical and Functional Specifications", in accordance with article 10 of Ordinance no. 65/2015, of march 5.