Cosmetic products vs. Medicinal products – Classification guidelines

Summary of the Guidance Document:

The “Guidance Document of the Demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83 as agreed between the Commission Services and the Competent Authorities of the EU Member States” document attempts to provide guidance for the classification of products that may simultaneously fulfill the definition of a cosmetic product (as per the 76/768 Directive) as well as the definition of a medicinal product (as per the 2001/83 Directive).

The document presents the definition of a cosmetic product (as per the 76/768 Directive) and the definition of a medicinal product (as per the 2001/83 Directive) focusing on the main characteristics and the essential differences between the two. Furthermore, it presents the different criteria that must be considered when the classification of a product that seems to fall under both directives arises. Among these criteria are:

• Mode of application
• Principal purpose of use
• Principal action/function of the product (e.g., pharmacological, immunological, restorative, corrective etc.)
• Product’s presentation

The document concludes by explaining the principle of non-cumulation which states that for a product that falls under the definition of both a medicinal product and a cosmetic product the possibility of both regulatory regimes to be applied is excluded. In this situation the regulatory regime of the medicinal directive will be applicable.

For an in-depth and comprehensive reading of the guidance document on Classification guidelines between Cosmetics & Medicinal products – this guidance document may be found on our Legislation web page – Click Here.


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