MEDDEV 2.1/3 Rev. 3 DRAFT PROPOSAL
25th of November 2015 B&C WG
“Pharmacological means” is understood as any type1 of interaction between
the molecules of the substance in question or its metabolites and a constituent
of the human body (including any of its parts) or an organism or other
pathogens within or on the body) which results for example2 in initiation,
enhancement, mitigation or blockade of physiological or pathological
characteristics.
Although not a completely reliable criterion, the presence of a dose-response
correlation is indicative of a pharmacological effect.
Examples of constituents of the human body may include, among others2: cells
and their constituents, i.e. proteins (including membrane proteins and sticky
proteins2, ion channels, enzymes, antibodies) and intracellular structures.
“Immunological means” is understood as an action mediated or exerted
(including e.g. stimulation, modulation, replacement) by immune2 cells (e.g.
lymphocytes, phagocytes, macrophages, dendritic cells) and/or by molecules
involved in overall immunological response (e.g. toll-like receptors,
complement factors, cytokines, antibodies).
A means of action can be considered “immunological” only when the induction ,
modulation or blocking of the2 immune response is the primary intended
consequence of the administration of a substance.
Examples: vaccines, antibodies, antivenoms and certain therapies which
depend on an immunological means to target them.
“Metabolic means” is understood as an action which involves an alteration,
including stopping, starting or changing the rate, extent or nature of a
physiological3 or pathological processes participating in, and available for,
function of the human body (including any of its parts) or an organism or
pathogen within or on the body).
Metabolism is the set of physiological3 reactions that happen in living
organisms. It includes processes for cell growth, reproduction, response to
environment, sustenance, and maintenance of cell structure and integrity.
1
FR, Eurom VI, Eucomed, AESGP
DGSANCO
3
Eurom VI
2
Note 1: Definition of substance (Directive 2001/83/EC)
Substance: Any matter irrespective of origin which may be:
 human, e.g. human blood and human blood products;
 animal, e.g. micro-organisms, whole animals, parts of organs, animal
secretions, toxins, extracts, blood products;
 vegetable, e.g. micro-organisms, plants, parts of plants, vegetable
secretions, extracts;
 chemical, e.g. elements, naturally occurring chemical materials and
chemical products obtained by chemical change or synthesis.
Note 2:
A product may achieve its principal intended action by metabolic means
irrespective of whether is or is not itself metabolised.
Note 3: A chemical binding is any type of binding (e.g. covalent binding,
electrostatic interactions – van der Waals forces, H-bonds, covalent binding).
The effect of a chemical binding which does not mediate, directly or indirectly,
a pharmacological, immunological or metabolic means should be reproducible
in vitro in a closed, not biological, inert system.
On the other hand, the effect of a chemical binding which mediates
pharmacological, immunological or metabolic means should be reproducible
only in a biological system.