Case C-15/01: Reference for a preliminary ruling from the Regeringsrätten (Supreme Administrative Court) — by decision of that court of 21 December 2000 in the case of Paranova Läkemedel AB, Farmagon A/S, Medartuum AB, K.G. NetPharma AB, Orifarm AB, Trans Euro Medical AB, Cross Pharma AB and MedImport Scandinavia AB v Läkemedelsverket (Medical Products Agency)
Date: 2001-03-10
Institutions: Court of Justice
Subjects: import, import licence, import policy, interpretation of the law, marketing, medicinal product

10.3.2001

EN

Official Journal of the European Communities

C 79/17

Reference for a preliminary ruling from the Regeringsrät-
ten (Supreme Administrative Court) — by decision of
that court of 21 December 2000 in the case of Paranova
Läkemedel AB, Farmagon A/S, Medartuum AB, K.G. Net-
Pharma AB, Orifarm AB, Trans Euro Medical AB, Cross
Pharma AB and MedImport Scandinavia AB v Läke-
medelsverket (Medical Products Agency)

(Case C-15/01)

(2001/C 79/29)

Reference has been made to the Court of Justice of the
European Communities by a decision of the Regeringsrätten
— of 21 December 2000, which was received at the Court
Registry on 15 January 2001, for a preliminary ruling in the
case of Paranova Läkemedel AB, Farmagon A/S, Medartuum
AB, K.G. NetPharma AB, Orifarm AB, Trans Euro Medical
AB, Cross Pharma AB and MedImport Scandinavia AB v
Läkemedelsverket on the following questions:

1.

2.

Is it compatible with Articles 28 and 30 EC to revoke a
marketing authorisation for a medicinal product import-
ed as a parallel import on the ground that the marketing
authorisation for the directly imported medicinal product
has been revoked at the request of the holder of the
authorisation for reasons unconnected with the safety of
the medicinal product? Does the answer depend on what
specific reasons have given rise to that request or on
whether the holder of the authorisation or companies
belonging to the same group in other Member States
continue to sell the medicinal product to which the
parallel imports relate on the basis of marketing authoris-
ations granted there?

If the parallel importers rely on a new marketing authoris-
ation for a directly imported medicinal product rather
than on the old marketing authorisation, is authorisation
for the continued marketing of the medicinal product
imported as a parallel
import precluded by the fact
that that medicinal product and the directly imported
medicinal product which is covered by the new marketing
authorisation are different in the sense that the medicinal
product imported as a parallel import is sold in the form
of a capsule containing a certain acid (omeprazole) while
the directly imported medicinal product is sold in the
form of a tablet containing a magnesium salt of the acid?

Reference for a preliminary ruling by the Verwaltungsge-
richtshof by order of that court of 18 December 2000
in the case of Paul Dieter Haug against Unabhängiger
Verwaltungssenat Wien

(Case C-16/01)

(2001/C 79/30)

Reference has been made to the Court of Justice of the
European Communities by order of the Verwaltungsgerichts-
hof (Administrative Court of Appeal) of 18 December 2000
which was received at the Court Registry on 15 January 2001,
for a preliminary ruling in the case of Paul Dieter Haug
against Unabhängiger Verwaltungssenat Wien (Independent
Administrative Chamber for Vienna) on the following ques-
tions:

1. Does Article 2(1)(b) of Council Directive 79/112/EEC of
18 December 1978 on the approximation of the laws of
the Member States relating to the labelling, presentation
and advertising of foodstuffs for sale to the ultimate
consumer (now consolidated in European Parliament and
Council Directive 2000/13/EC of 20 March 2000 — OJ
2000 L 109, p. 29), under which — subject to Com-
munity provisions applicable to natural mineral waters
and to foodstuffs for particular nutritional uses — the
labelling and methods used may not attribute to any
foodstuff the property of preventing, treating or curing a
human disease, or suggest that it possesses such proper-
ties, preclude national
legislation which makes it an
offence when marketing foodstuffs:

(a)

(b)

(c)

to refer to physiological or pharmacological effects,
in particular those which preserve youthfulness,
inhibit signs of ageing, promote slimming or main-
tain health, or to create the impression of any such
effect;

to refer to case-histories, recommendations made by
doctors or medical experts’ reports;

to use health-related, pictorial or stylised represen-
tations of organs of the human body, pictures
of members of the health-care professions or of
sanatoria or other pictures or illustrations referring
to health-care activities?

2. Do Directive 79/112/EEC or Articles 28 and 30 EC
preclude a national provision which, on the placing into
circulation of foodstuffs, permits health-related infor-
mation such as that described in Question (1) to be
affixed thereto only after prior authorisation by the
federal minister, whereby a condition of
competent
authorisation is that the health-related information is
consistent with protecting the consumer from being
misled?