Medicinal product (legal definition)

Under both French and EU law, a medicinal product is any substance or combination of substances presented as having properties for treating or preventing disease in human beings or animals, and any substance or combination of substances which may be used in or administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action. This definition is set out in Article L. 5111-1 of the French Public Health Code, which transposes Directive 2001/83/EC. The classification governs the entire regime applicable to the product, starting with the requirement for a marketing authorisation.

Medicinal products by presentation and by function

The definition combines two alternative criteria. A medicinal product by presentation is a product that its manufacturer presents, through its labelling, package leaflet, form or advertising, as intended to cure or prevent a disease, even if it has no actual efficacy. A medicinal product by function is a product that actually exerts a pharmacological, immunological or metabolic action. The Court of Justice of the European Union holds that this classification must be assessed case by case, having regard to the properties of the product as established by scientific knowledge, its manner of use and the risks it may entail, and that a product which does not significantly modify physiological functions is not a medicinal product by function.

The rule of precedence and neighbouring products

Where a product may fall within both the definition of a medicinal product and that of another regulated category, it is, in case of doubt, treated as a medicinal product. This rule of precedence, laid down by the Public Health Code and by the Directive, applies mainly at the boundary with food supplements, cosmetics and medical devices. The classification of a borderline product gives rise to extensive litigation, both administrative and criminal, notably on the ground of the illegal practice of pharmacy.

The consequences of classification

Classification as a medicinal product entails an authorisation requirement before any marketing, manufacture and distribution through a pharmaceutical establishment, retail sale within the pharmaceutical monopoly and strict control of advertising. Regulation (EC) No 469/2009 adopts a definition of medicinal product close to that of the Directive, and only a product authorised as a medicinal product can found a supplementary protection certificate.

Key points

A product is a medicinal product either because it is presented as such or because it acts as such, and any doubt is resolved in favour of that classification, which determines the authorisation required, the distribution channel and access to the supplementary protection certificate. Before launching a health product that sits at the boundary of several regimes, its classification should be checked against its composition, its claims and its presentation, since a poorly controlled therapeutic claim is enough to bring the product within the medicinal product regime.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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