1. Challenges and regulatory context

First of all, we need to clarify the concept of a drug. According to the terms of the French Public Health Code, a drug can be :

• "... any substance or composition presented as having curative or preventive properties with respect to human or animal diseases..."; case of a medicinal product by presentation;

• "... any substance or composition which may be used in or administered to humans or animals, with a view to making a medical diagnosis or to restoring, correcting or modifying their physiological functions by exerting a pharmacological, immunological or metabolic action..."; case of a drug by function.

Thus, a product may be classified as a medicinal product on the basis of its qualitative and/or quantitative composition, or on the basis of the information affixed to its...