Overlapping Definitions of Drugs, Topical Medical Devices, Cosmetics.

The cosmetic efficacy: myth or reality?

Abstract

The purpose of this paper is to outline the main issues arising out from the possible overlapping in the definitions provided for by the law for medicina! products, topical medicai devices and cosmetics. The Legislators carefully consider the need to clearly determine the demarcation between these different categories of products and recognizes that the determination of clear borderline among products is aimed at enhancing for the proper implementation of the European Directives and the correct interpretation and enforcement of transposing national laws. Nevertheless quite often happens that overlapping spaces objectively occur so to originate borderline cases where the parties involved (mainly companies and competent authorities) have to find fair solutions. With the support of the European Court of Justice interpretation and of the Guidance Documents concerning borderline products issued by the European Commission (and agreed between the Commission services and the competent authorities ofMember States) it is possible to identify a correct approach to the matter which caveat are figured in the following paper.