Judgment of the Court (Sixth Chamber) of 11 December 2003 in Case C-127/00 (Reference for a preliminary ruling from the Bundesgerichtshof): Hässle AB v Ratiopharm GmbH (Council Regulation (EEC) No 1768/92 — Medicinal products — Supplementary protection certificate — Articles 15 and 19 — Validity of Article 19 — Concept of "first authorisation to place … on the market in the Community" — Legal effects of non-compliance with the relevant date referred to in Article 19)
Date: 2004-02-21
Institutions: Court of Justice
Subjects: interpretation of the law, market approval, marketing standard, medicinal product

21.2.2004

EN

Official Journal of the European Union

C 47/1

I

(Information)

COURT OF JUSTICE

COURT OF JUSTICE

JUDGMENT OF THE COURT

(Sixth Chamber)

of 11 December 2003

in Case C-127/00 (Reference for a preliminary ruling
from the Bundesgerichtshof): Hässle AB v Ratiopharm
GmbH (1)

(Council Regulation (EEC) No 1768/92 — Medicinal prod-
ucts — Supplementary protection certificate — Articles 15
and 19 — Validity of Article 19 — Concept of ‘first
authorisation to place ... on the market in the Community’
— Legal effects of non-compliance with the relevant date
referred to in Article 19)

(2004/C 47/01)

(Language of the case: German)

(Provisional translation; the definitive translation will be published
in the European Court Reports)

In Case C-127/00: Reference to the Court under Article 234
EC by the Bundesgerichtshof (Germany) for a preliminary
ruling in the proceedings pending before that court between
Hässle AB and Ratiopharm GmbH, on the interpretation of
Articles 15 and 19 of Council Regulation (EEC) No 1768/92
of 18 June 1992 concerning the creation of a supplementary
protection certificate for medicinal products (OJ 1992 L 182,
p. 1), the Court (Sixth Chamber), composed of: V. Skouris,
acting for the President of
the Chamber, C. Gulmann,
J.N. Cunha Rodrigues, R. Schintgen and F. Macken (Rappor-
teur), Judges; C. Stix-Hackl, Advocate General; D. Louterman-
Hubeau, Head of Division, for the Registrar, has given a
judgment on 11 December 2003, in which it has ruled:

Consideration of the second question referred has disclosed no
factor capable of affecting the validity of Article 19 of Council
Regulation (EEC) No 1768/92 of 18 June 1992 concerning
the creation of a supplementary protection certificate for
medicinal products.

1.

2.

the Community’ in Article 19(1) of Regulation No 1768/92
refers solely to the first authorisation required under provisions
on medicinal products, within the meaning of Council Directive
65/65/EEC of 26 January 1965 on the approximation of
provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products, granted in any of the
Member States, and does not therefore refer to authorisations
required under legislation on pricing of or reimbursement for
medicinal products.

3. A supplementary protection certificate which, contrary to the
requirements of Article 19 of Regulation No 1768/92, has
been delivered where the first marketing authorisation in the
Community was obtained prior to the relevant date fixed by
that provision is invalid pursuant to Article 15 thereof.

(1) OJ C 163 of 10.6.2002.

JUDGMENT OF THE COURT

of 13 January 2004

in Case C-440/00 (Reference for a preliminary ruling from
the Bundesarbeitsgericht ): Gesamtbetriebsrat der Kühne
& Nagel AG & Co. KG v Kühne & Nagel AG & Co. KG (1)

(Social policy — Articles 4 and 11 of Directive 94/45/EC —
European Works Councils — Informing and consulting
employees in Community-scale undertakings — Group of
undertakings whose central management is not located in a
Member State)

(2004/C 47/02)

(Language of the case: German)

(Provisional translation; the definitive translation will be published
in the European Court Reports)

So far as concerns medicinal products for human use, the
concept of ‘first authorisation to place ... on the market ... in

In Case C-440/00: Reference to the Court under Article 234
EC by the Bundesarbeitsgericht (Germany) for a preliminary