Medicinal product by presentation: how marketing changes a product's legal status

Why can the way a research material is described make it legally a medicine, even when the vial is identical?

Whether a product is legally a medicine is not decided by its chemistry alone. Directive 2001/83/EC defines a medicinal product by two independent criteria: the claim or presentation attached to the product, and its function in the body. Either one is enough. Two identical vials of the same substance can therefore fall under different regimes, depending on what the seller's page or label says.

For anyone buying or handling research-use-only material, the conclusion is practical. A seller's claims are evidence for regulators too. A description that points to therapeutic use can move a product from the category of laboratory reagent into the category of a medicine with no marketing authorisation. This article explains the test, not what to do with any particular product.

Article 1 of the directive: two definitions, one product

Article 1(2) of Directive 2001/83/EC defines as a medicinal product, first, any substance or combination of substances presented as having properties for treating or preventing disease in human beings. Second, it covers any substance or combination which may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis ^[1].

In legal language these are «medicinal product by presentation» and «medicinal product by function». Both do not need to be met. A product meeting either is a medicinal product for the purposes of the directive, and the basic requirement of Article 6(1) applies: no medicinal product may be placed on the market of a member state without a marketing authorisation ^[1].

There is also a rule for borderline cases. Under Article 2(2), where a product may fall within the definition of a medicinal product and also within a category governed by other Union legislation, in cases of doubt the provisions of the medicines directive apply ^[1]. Case law has clarified its limits, as shown below.

«By presentation»: claims, images, associations

The presentation criterion is broad by design. In essence it judges how the product is shown to the consumer: by an express claim of therapeutic or preventive properties or, in the Court of Justice's familiar formulation, in a way that creates in the mind of the average consumer, even implicitly but with certainty, the impression that it has such properties. That formulation comes from earlier judgments of the Court and should be checked in the judgments themselves.

In Hecht-Pharma the Court noted that the broad interpretation of presentation exists to protect consumers from products that lack the effectiveness they are entitled to expect ^[2]. The logic is that the risk to a consumer does not depend only on whether the substance acts, but on whether the consumer is led to believe that it acts.

In practice many elements can make up the presentation: the title and text of the page, photographs, references to diseases or symptoms, references to outcomes or user reviews, accompanying leaflets, packaging, and even the page layout beside authorised medicines. None decides the matter alone, but together they are the material an authority examines.

«By function»: what the Court examined in Hecht-Pharma

Case C-140/07 concerned capsules made from fermented red rice, sold in Germany as a food supplement, containing a substance identical to the active ingredient of prescription medicines. The German authorities treated them as an unauthorised medicine. The Court considered three questions: how the doubt rule works, when a product with a low content of a substance is a medicine by function, and whether the case-law criteria still apply after the definition was amended ^[2].

Three findings stand out. First, the directive does not apply to a product for which it has not been scientifically established that it is a medicine by function, even if that possibility cannot be excluded; the doubt rule does not replace scientific evidence. Second, a product is not a medicine by function if, given its composition and intended use, it cannot appreciably restore, correct or modify physiological functions. Third, the characteristics identified in earlier case law, such as manner of use, distribution, consumer familiarity and risks, remain relevant ^[2].

The conclusion for a reader is twofold. The function criterion is scientific and hard for an authority to show without data. The presentation criterion can be shown from a screenshot. That is why a seller's description often weighs more than the chemistry.

The Greek framework and the role of EOF

The directive does not apply directly: it was transposed into Greek law, and the competent authority for medicines is the National Organisation for Medicines (EOF). The specific transposing instrument was not verified for this article and is not cited. What can be checked against a primary source is two public tools of EOF: its announcements page and its product search ^[3][4].

The product search is the first practical test for the existence of an authorisation: a product presented as a medicine that does not appear there has no authorisation in Greece ^[4]. The Organisation's announcements page is where warnings to the public are published; its content changes and should be read in its current form ^[3]. For the framework that separates a medicine from a research material, see also the article comparing the two.

What it means for a buyer: same volume, different status

The table is not a list of forbidden phrases; it describes what an authority examines. Status is determined by the whole, and the final judgement belongs to the competent authority and, if necessary, the courts.

How to read a seller's page with this test

The question worth asking has two parts: what the seller states the material is, and what the seller implies it does. For a fuller non-legal picture of what a seller of research chemicals is allowed to claim, the corresponding reference site has a detailed text.

• Is it stated expressly that the product is intended solely for laboratory research?
• Are there references to diseases, symptoms or bodily outcomes in people?
• Are there reviews or testimonials describing use in people?
• Is analytical documentation (a certificate of analysis with a lot number) provided, or only a price list?
• Does the description on the product page agree with the texts, labels and accompanying documents?
• Is there a contact point and a legal identity for the seller?

Where the test stops and what this article does not say

This article describes the definition, not penalties or enforcement procedure. The consequences of unlawful promotion are covered in the article on unlawful promotion and sanctions. The comparison of three categories, medicine, supplement and research material, is made in a separate text. And the classification of a specific product cannot be made by an article: it belongs to the competent authority.