Case C-140/07: Judgment of the Court (First Chamber) of 15 January 2009 (reference for a preliminary ruling from the Bundesverwaltungsgericht — Germany) — Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg (Directive 2001/83/EC — Articles 1(2) and 2(2) — Concept of medicinal product by function — Product in respect of which it has not been established that it is a medicinal product by function — Account taken of the content in active substances)
Date: 2009-01-15
Institutions: Court of Justice
Subjects: interpretation of the law, medicinal product, pharmaceutical legislation, product quality, public health

C 55/2

EN

Official Journal of the European Union

7.3.2009

V

(Announcements)

COURT PROCEEDINGS

COURT OF JUSTICE

Judgment of the Court (First Chamber) of 15 January 2009
(reference for a preliminary ruling from the Bundes-
verwaltungsgericht — Germany) — Hecht-Pharma GmbH
v Staatliches Gewerbeaufsichtsamt Lüneburg

(Case C-140/07) (1)

and of the Council of 31 March 2004 (OJ 2004 L 136, p. 34)
— Classification as a medicinal product of a product containing
a component capable of producing physiological changes in the
event of consumption of a greater dose than intended for
normal use — Applicability of Directive 2001/83/EC to a
product which could possibly be classified as a medicinal
product but whose quality of a medicinal product has not been
determined — Concept of medicinal product

(Directive 2001/83/EC — Articles 1(2) and 2(2) — Concept
of ‘medicinal product by function’ — Product in respect of
which it has not been established that it is a medicinal product
in active
by function — Account

the content

taken of
substances)

(2009/C 55/02)

Language of the case: German

Referring court

Bundesverwaltungsgericht

Parties to the main proceedings

Applicant: Hecht-Pharma GmbH

Defendant: Staatliches Gewerbeaufsichtsamt Lüneburg

Intervening
Bundesverwaltungsgericht

Party: Vertreterin

des

Bundesinteresses

beim

Re:

Operative part of the judgment

1. Article 2(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
the
Directive 2004/27/EC of
Council of 31 March 2004, must be interpreted as meaning that
Directive 2001/83, as amended by Directive 2004/27, does not
apply to a product in respect of which it has not been scientifically
established that it is a medicinal product by function, without its
being possible to exclude that possibility.

the European Parliament and of

2. Article 1(2)(b) of Directive 2001/83, as amended by Directive
2004/27, must be interpreted as meaning that the characteristics
of the manner in which a product is used, the extent of its distribu-
tion, its familiarity to consumers and the risks which its use may
entail are still relevant to determining whether that product falls
within the definition of a medicinal product by function.

3. Article 1(2)(b) of Directive 2001/83, as amended by Directive
2004/27, must be interpreted as meaning 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 a medicinal product within the meaning of that provi-
sion where, having regard to its composition — including its
content in active substances — and if used as intended, it is incap-
able of appreciably restoring, correcting or modifying physiological
functions by exerting a pharmacological, immunological or meta-
bolic action.

Reference for a preliminary ruling — Bundesverwaltungsgericht
— Interpretation of Articles 1(2) and 2(2) of Directive
2001/83/EC of the European Parliament and of the Council of
6 November 2001 on the Community code relating to medic-
inal products for human use (OJ 2001 L 311, p. 67), as
amended by Directive 2004/27/EC of the European Parliament

(1) OJ C 117, 26.5.2007.