Case C-356/08: Action brought on 30 July 2008 — Commission of the European Communities v Republic of Austria
Date: 2008-07-30
Institutions: Court of Justice
Subjects: Austria, European Commission, action for failure to fulfil an obligation, free movement of capital, freedom to provide services, health insurance, physician, right of establishment

C 247/10

EN

Official Journal of the European Union

27.9.2008

to quality, safety and efficacy, in particular those laid down
in Section 4 of Part II of Annex I to Directive 2001/83/EC,
as amended by Directive 2003/63/EC.

(iii) The competent institutions of the Republic of Lithuania
have themselves established that the documents relating to
the medicinal product ‘Grasalva’ do not contain any infor-
mation concerning pre-clinical or clinical trials provided in
accordance with Section 4 of Part II of Annex I to Directive
2001/83/EC,
amended by Directive 2003/63/EC,
concerning compliance by the medicinal product ‘Grasalva’
with the safety and efficacy requirements applied to similar
biological medicinal products.

as

fails

to meet

‘Grasalva’

(iv) The national marketing authorisation for the medicinal
product
the requirements of
Section 4 of Part II of Annex I to Directive 2001/83/EC, as
amended by Directive 2003/63/EC, with the result that, as
from the date of accession, that medicinal product could be
placed on the market only if marketing authorisation for it
had been granted centrally pursuant to Article 3(1) of Regu-
lation (EEC) No 2309/93 (applied up to 20 November
2005) or Article 3(1) of Regulation (EC) No 726/2004
(applicable from 21 November 2005).

(1) Directive 2001/83/EC of

the
Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ 2001 L 311, p. 67).

the European Parliament and of

(2) Commission Directive 2003/63/EC of 25 June 2003 amending
Directive 2001/83/EC of
the
Council on the Community code relating to medicinal products for
human use (OJ 2003 L 159, p. 46).

the European Parliament and of

(3) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down
Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products (OJ 1993
L 214, p. 1).

(4) Regulation (EC) No 726/2004 of the European Parliament and of the
Council of 31 March 2004 laying down Community procedures for
the authorisation and supervision of medicinal products for human
and veterinary use and establishing a European Medicines Agency
(OJ 2004 L 136, p. 1).

Form of order sought

— declare that, by imposing an obligation on every medical
doctor becoming established in Oberösterreich (Land of
Upper Austria) to open a bank account with the Oberöster-
reichische Landesbank to which fees for benefits in kind are
to be transferred by the health insurance funds, the Republic
of Austria has failed to comply with its obligations under
Articles 43 EC, 49 EC and 56 EC;

— order the Republic of Austria to pay the costs.

Pleas in law and main arguments

The mandatory opening of an account, to which, moreover, all
fees for benefits in kind from health insurance funds must be
transferred, is disproportionate to the need to ensure the proper
calculation and levying of
the contributions payable to the
medical councils by medical doctors established in Oberöster-
reich. The disputed rules for that reason amount to unjustified
restrictions of three fundamental freedoms guaranteed by the
Treaty, namely the freedom of establishment of medical doctors
established in other Member States and that of banks, their
freedom to provide services and the free movement of capital.

Action brought on 4 August 2008 — Commission of the
European Communities v Hellenic Republic

(Case C-357/08)

(2008/C 247/18)

Language of the case: Greek

Parties

Action brought on 30 July 2008 — Commission of the
European Communities v Republic of Austria

Applicant: Commission of the European Communities (repre-
sented by: G. Zavvos)

(Case C-356/08)

(2008/C 247/17)

Language of the case: German

Parties

Applicant: Commission of the European Communities (repre-
sented by: E. Traversa and A. Böhlke, Agents)

Defendant: Hellenic Republic

Form of order sought

the European Parliament and of

— declare that, by not adopting the laws, regulations and
administrative provisions necessary to comply with Directive
2005/14/EC (1) of
the
Council of 11 May 2005 amending Council Directives
72/166/EEC, 84/5/EEC, 88/357/EEC and 90/232/EEC and
Directive 2000/26/EC of the European Parliament and of
the Council relating to insurance against civil
liability in
respect of the use of motor vehicles, or in any event by not
notifying those provisions to the Commission, the Hellenic
Republic has failed to fulfil its obligations under that direc-
tive;

Defendant: Republic of Austria

— order the Hellenic Republic to pay the costs.