A guide to what is a medicinal product

• the pharmacological, immunological or metabolic properties of the ingredient(s) and any
significant effect(s) the product will have on physiological function in humans, or in the case
of a product which satisfies the definition of a traditional herbal medicinal product in
Directive 2004/24/EC where the pharmacological, immunological or metabolic effects or
efficacy are considered plausible on the basis of long standing use and tradition
• the composition of the product
• the manner in which the product is used
• the product promotional literature, including testimonials and any literature issued by a third
party on behalf of the person who places the product on the market
• the familiarity of the product to consumers and the extent of its distribution in the UK
• the product form, (capsule, tablet, injection, etc.) and the way it is to be used
• the presence of essentially similar licensed, registered or exempt medicines on the UK
market
• the risks which use of the product may pose.
7. Products that are not classified as medicines under the “functional” limb of the
definition of a medicinal product
The MHRA only classifies finished products and not individual substances and ingredients. A
product will not be classified as a medicine solely on the basis that it may be unsafe for human
use. A product must be intended for, or be capable of performing, a medicinal function before it can
be classified as such.
Products containing chemicals or substances that were primarily developed for non-medicinal
purposes, such as for industrial (e.g. chemical) processes or agricultural use, and which have no
valid use in clinical practice are unlikely to fall within the function limb.
The Judgment in the joined cases Markus D (C-358/13) and G. (C-181/14) concerns the
classification of substances that are not intended to be consumed for a medical but for a
recreational purpose. For products to fall under the Directive 2001/83/EC the ECJ Judgment
states:
“…for the purpose of determining whether a product falls within the definition of a medicinal
product for the purposes of Directive 2001/83, the national authorities, acting under the supervision
of the courts, must decide on a case-by-case basis, taking account of all the characteristics of the
product, in particular its composition, its pharmacological, immunological or metabolic properties,
to the extent to which they can be established in the present state of scientific knowledge, the
manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks
which its use may entail (the judgments in Upjohn, EU:C:1997:147, paragraph 23, and BIO
Naturprodukte, C-27/08, EU:C:2009:278, paragraph 18)”;
The Judgment concluded that “Article 1(2)(b) of Directive 2001/83 must be interpreted as not
covering substances, such as those at issue in the main proceedings, which produce effects that
merely modify physiological functions but which are not such as to have any beneficial effects,
either immediately or in the long term, on human health, are consumed solely to induce a state of
intoxication and are, as such, harmful to human health.” [Emphasis underlined.]
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