CELEX: 62008CJ0027
Directive 2001/83/EC
Article 1(2)(b)
Concept of ‘medicinal product by function’
Dosage of the product
Normal conditions of use
Risk to health
Ability to restore, correct or modify physiological functions in human beings

This reference for a preliminary ruling concerns the interpretation of Article 1(2) of Directive 2001/83/EC of the European
Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311,
p. 67), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136,
p. 34) (‘Directive 2001/83’).
The reference has been made in the course of proceedings between BIOS Naturprodukte GmbH (‘BIOS Naturprodukte’) and Saarland
concerning the classification of a product referred to as ‘Weihrauch H 15-Tabletten’ (H 15 incense tablets) for the purpose
of its marketing in German territory.

Legal context

Community legislation
Under  Article 1(2) of Directive 2001/83, ‘medicinal product’ is to be understood to mean:
‘…
(a)      Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;
or
(b)      Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring,
correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making
a medical diagnosis’.

National legislation
The term ‘medicinal product’ is defined in Paragraph 2(1) of the Law on medicinal products (Arzneimittelgesetz), in its version
of 11 December 1998 (BGBl. 1998 I, p. 3586) (‘the AMG’).
In accordance with Paragraph 69(1) of the AMG, the competent authorities are to take the necessary steps to eliminate infringements
that have been found and to prevent new ones. They may, in particular, prohibit the placing on the market of medicinal products
if the authorisation or registration required for such products is absent.

The dispute in the main proceedings and the question referred for a preliminary ruling
BIOS Naturprodukte placed on the market in Germany a product called ‘Weihrauch H 15‑Tabletten’ as a food supplement.
That preparation, which is based on Indian incense extract, is produced in India and imported into Austria, where it is marketed
as a food product. In addition to various excipients, each tablet contains 400 mg of Indian incense extract. According to
the information which features on the packaging, the recommended dosage is one tablet to be taken daily with a little liquid
after a meal.
By decision of 23 January 2002, Saarland, pursuant to Paragraph 69(1) of the AMG, prohibited BIOS Naturprodukte from continuing
to offer that product on the German market on the ground that it was a medicinal product which had not received prior marketing
authorisation. Referring to comparable legislation in India, that decision placed the product in the category of medicinal
products for which a marketing authorisation is required.
BIOS Naturprodukte brought an action against that decision in which it submitted that the product in issue in the main proceedings
is a food supplement and not a medicinal product. Before the Verwaltungsgericht (Administrative Court), it argued that the
product concerned is neither a medicinal product by presentation, since it is expressly described as a food supplement on
the packaging and no reference is made to any therapeutic or prophylactic effects, nor a medicinal product by function, since
the recommended daily dose of 400 mg has no pharmacological action, as shown by two expert reports which it provided. It also
indicated that, in line with the traditional use of incense extract as an aroma and a spice, the product concerned served
a nutritional purpose.
By judgment of 20 May 2003, the Verwaltungsgericht dismissed that action on the ground that, in view of its purpose, the product
at issue in the main proceedings was, in the perception of the trade, predominantly regarded as a medicinal product.
By judgment of 3 February 2006, the Oberverwaltungsgericht (Higher Administrative Court) dismissed the appeal brought by BIOS
Naturprodukte on the ground that the product in issue in the main proceedings was to be regarded as a medicinal product since
it satisfies the definition of medicinal product set out in Article 1(2) of Directive 2001/83.
Having regard to its designation as a food supplement and the fact that there was no evidence whatsoever of any therapeutic
purpose, the Oberverwaltungsgericht found that the product concerned in the main proceedings was not a medicinal product by
presentation. None the less, that court reached the conclusion, on the basis of recent results of scientific research, that
it was a medicinal product by function. It stated in that regard that incense extract has an anti‑inflammatory effect when
used in daily doses of between 800 mg and 1 600 mg and that incense extract may, by contrast, have the opposite effect of
aiding inflammatory processes when used in low doses, as is the case of the product concerned in the main proceedings.
The Oberverwaltungsgericht, which, however, accorded no importance to the therapeutic effects of the incense extract used
in stronger doses than that recommended, took the view that it was necessary, in the light of the objective of health protection,
to find that the negative effects of a product used in an insufficient dosage also came under pharmacological action.
BIOS Naturprodukte brought proceedings for judicial review against the judgment of the Oberverwaltungsgericht.
The Bundesverwaltungsgericht takes the view that the question arises in the case in the main proceedings not only as to whether
a product can be regarded as a medicinal product by function where it contains an ingredient capable, in a particular dose,
of bringing about physiological changes, but where the dosage of the product concerned remains, in normal conditions of use,
below that dose, but also as to whether a risk to health linked to use of a product, arising precisely from the use of an
insufficient dose of that product, may result in that product having to be classified as a medicinal product.
As it took the view that the resolution of the dispute before it depended on the interpretation of Article 1(2) of Directive
2001/83, the Bundesverwaltungsgericht decided to stay the proceedings and to refer the following question to the Court of
Justice for a preliminary ruling:
‘Is the definition of medicinal product in Article 1(2) of Directive 2001/83 ... to be interpreted to the effect that a product
intended for human consumption and described as a food supplement is a medicinal product by function if it contains substances
which pose a risk to health in the low dose contained in the product when the recommended intake printed on the packaging
is observed, without being capable of producing therapeutic effects, but which have therapeutic effects in high doses?’

The question referred for a preliminary ruling
By its question, the national court asks, essentially, whether Article 1(2) of Directive 2001/83 is to be interpreted as meaning
that a product which includes in its composition a substance which has a physiological effect when it is used in a particular
dosage is a medicinal product by function since, regard being had to its content in active substances and under normal conditions
of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological
functions in human beings.
First of all, it should be pointed out that, for the purpose of determining whether a product falls within the definition
of a medicinal product by function 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 (Case C‑140/07
Hecht‑Pharma
[2009] ECR I‑0000, paragraph 39).
It follows that products containing a substance which has a physiological effect cannot automatically be classified as medicinal
products by function unless the competent administration has made an assessment, with due diligence, of each product individually,
taking account, in particular, of that product’s specific pharmacological, immunological or metabolic properties, to the extent
to which they can be established in the present state of scientific knowledge (
Hecht‑Pharma
, paragraph 40).
The pharmacological, immunological or metabolic properties of a product constitute, in fact, the factor on the basis of which
it must be ascertained, in the light of the potential capacities of the product, whether it may, for the purposes of Article 1(2)(b)
of Directive 2001/83, be used in or administered to human beings with a view to restoring, correcting or modifying physiological
functions (see, to that effect, Case C‑319/05
Commission
v
Germany
[2007] ECR I‑9811, paragraph 59).
In that regard, it should be borne in mind that the capacity to restore, correct or modify physiological functions should
not lead to the classification as medicinal products by function of products which, while having an effect on the human body,
do not significantly affect the metabolism and thus do not strictly modify the way in which it functions (
Hecht‑Pharma
, paragraph 41).
When that assessment is being made, the normal conditions of use of the product in question should be taken into account (see,
to that effect, Case C‑150/00
Commission
v
Austria
[2004] ECR I‑3887, paragraph 75), and the fact that it is capable of having a significant physiological effect when used
at a higher dosage than that indicated in the instructions or on the packaging is irrelevant in that regard.
It follows from the foregoing considerations that, apart from the case of substances or combinations of substances intended
for the purpose of making a medical diagnosis, a product cannot be regarded as being a medicinal product by function where,
having regard to content and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological
functions in human beings (see, to that effect,
Hecht‑Pharma
, paragraph 42).
This conclusion is not invalidated by the fact that the product in question, under normal conditions of use, may involve a
risk to health.
In that regard, it should be borne in mind, first, that the fact that the use of a product presents a risk to health is not
an indication that it is pharmacologically effective. The risk to health, although it must be taken into consideration in
the classification of a product as a medicinal product by function, is none the less an autonomous factor (see
Commission
v
Germany
, paragraph 69).
Second, a risk to health is only one aspect of the product which must be taken into consideration by the competent national
authorities for the purpose of assessing whether it is a medicinal product within the meaning of Article 1(2)(b) of Directive
2001/83, and cannot be the only determining factor (see, to that effect,
Commission
v
Austria
, paragraph 65).
Consequently, the answer to the question referred is that Article 1(2) of Directive 2001/83 must be interpreted as meaning
that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage
is not a medicinal product by function where, having regard to its content in active substances and under normal conditions
of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological
functions in human beings.

Costs
Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court,
the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs
of those parties, are not recoverable.
On those grounds, the Court (Fifth Chamber) hereby rules:
Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code
relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council
of 31 March 2004, must be interpreted as meaning that a product which includes in its composition a substance which has a
physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content
in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of
restoring, correcting or modifying physiological functions in human beings.
[Signatures]
*
Language of the case: German.