Interventional clinical studies of cosmetics

 

A «clinical study with the intervention of cosmetic products» is any study that implies clinical intervention involving healthy volunteers and conducted in accordance with a protocol in order to generate scientific knowledge.

The ultimate goal of the cosmetic product studied in the context of a clinical research should match the definition of «cosmetic product», even if the product tested during the investigation is not intended to clean, perfume, protect, change the appearance, keep in good condition or correct the odours of the various external parts of the human body where it is applied.

The new legal framework provided in article 34 of Law no. 21/2014, of april 16 imposes on the sponsor of the clinical study with the intervention of cosmetics the previous notification of this research to INFARMED, I.P., being this authority also responsible for supervision and control, as established by article 44 of the same law.

The clinical study with intervention of cosmetics can be started 30 days after notification to Infarmed, unless this authority issues a properly reasoned decision unfavorable to its realization.