Case C-452/06: Reference for a preliminary ruling from the High Court of Justice (England and Wales), Queen's Bench Division (Administrative Court) (United Kingdom) made on 9 November 2006 — The Queen on the application of Synthon BV v Licensing Authority, Interested Party: Smithkline Beecham plc
Date: 2006-12-30
Institutions: Court of Justice
Subjects: interpretation of the law, market approval, medicinal product, mutual recognition principle, pharmaceutical legislation

C 326/40

EN

Official Journal of the European Union

30.12.2006

Questions referred

Is Article 13B(b) of Sixth Council Directive 77/388/EEC of 17
May 1977 on the harmonisation of the laws of the Member
States relating to turnover taxes — Common system of value
added tax: uniform basis of assessment (1) (as last amended by
Council Directive 2006/69/EC of 24 July 2006 (2)), hereinafter
referred to as ‘the Sixth Directive’, to be interpreted as meaning
that the grant of the entitlement to fish, for consideration, in
the form of a lease concluded for a period of 10 years

1. by the owner of the property on which the body of water in

respect of which the entitlement was granted is located,

2. by the holder of fishing rights in respect of a body of water

located on public land

constitutes ‘the leasing or letting of immovable property’?

(1) OJ L 145, p. 1.
(2) OJ L 221, p. 9.

Reference for a preliminary ruling from the High Court of
Justice (England and Wales), Queen's Bench Division
(Administrative Court)
(United Kingdom) made on 9
November 2006 — The Queen on the application of
Interested Party:
Synthon BV v Licensing Authority,

Smithkline Beecham plc

(Case C-452/06)

(2006/C 326/84)

Language of the case: English

Referring court

High Court of Justice (England & Wales), Queen's Bench Divi-
sion (Administrative Court)

Parties to the main proceedings

Applicant: Synthon BV

Defendant: Licensing Authority

Interested Party: Smithkline Beecham plc

Questions referred

1. Where:

— a Member State (‘the concerned Member State’) receives
to Article 28 of Directive
an application pursuant
the
2001/83/EC of
Council of 6 November 2001 on the Community code

the European Parliament and of

for mutual

relating to medicinal products for human use (1)
(‘the
Directive’)
in the concerned
Member State of a marketing authorisation of a medicinal
product (‘the Product’) granted by another Member State
(‘the reference Member State’);

recognition,

— such marketing authorisation was granted by the refer-
ence Member State pursuant to the abridged application
procedure in Article 10(1)(a)(iii) of the Directive on the
grounds that the Product is essentially similar to another
medicinal product which has already been authorised
within the EU for the requisite period (‘the Reference
Product’);

— the concerned Member State operates a procedure for
validation of the application during which it checks that
the application contains the particulars and documents
required by Articles 8, 10(1)(a)(iii) and 28 of the Direc-
tive, including that the particulars provided are compa-
tible with the legal basis upon which the application is
submitted;

(a) is it compatible with the Directive and in particular
Article 28 for the concerned Member State to check
that the Product is essentially similar to the Reference
Product (without carrying out any substantive assess-
ment), to refuse to accept and review the application
and not proceed to recognise the marketing authori-
sation granted by the reference Member State on the
grounds that in its opinion the Product is not essen-
tially similar to the Reference Product? or

(b) is the concerned Member State obliged to recognise
the marketing authorisation granted by the reference
Member State within 90 days of receipt of the appli-
cation and the assessment report pursuant to Article
28(4) of the Directive unless the concerned Member
State invokes the procedure set out in Articles 29 to
34 of the Directive (which is applicable where there
are grounds for supposing that the marketing author-
isation of the Product may present a risk to public
health within the meaning of Article 29 of the Direc-
tive).

is not essentially similar

2. If the answer to question 1(a) is no and the answer to ques-
tion 1(b) is yes, where the concerned Member State rejects
the application at the validation stage on the grounds that
the Product
to the Reference
Product, and thereby fails to recognise the marketing authori-
sation granted by the reference Member State or to invoke
the procedure set out in Articles 29 to 34 of the Directive,
does the failure by the concerned Member State to recognise
the marketing authorisation granted by the
reference
Member State in the circumstances referred to above amount
to a sufficiently serious breach of Community law within the
meaning of the second condition in the judgment in Joined
Cases C-46/93 and C-48/93 Brasserie du Pecheur and Factor-
tame. Alternatively, what factors ought the national court to
take into consideration when it comes to determine whether
such failure amounts to a sufficiently serious breach?

30.12.2006

EN

Official Journal of the European Union

C 326/41

3. Where the failure of the concerned Member State to recog-
nise the marketing authorisation granted by the reference
Member State as set out in question 1 above is based on a
general policy adopted by the concerned Member State that
different salts of the same active moiety cannot, as a matter
of law, be considered essentially similar, does the failure by
the concerned Member State to recognise the marketing
authorisation granted by the reference Member State in the
circumstances referred to above amount
to a sufficiently
serious breach of Community law within the meaning of the
second condition in the judgment in Joined Cases C-46/93
and C-48/93 Brasserie du Pecheur and Factortame. Alternatively
what factors ought the national court to take into considera-
tion when it comes to determine whether such failure
amounts to a sufficiently serious breach?

(1) OJ L 311, p. 67

Reference for a preliminary ruling from the Bundesverwal-
tungsgericht (Germany) lodged on 13 November 2006 —
01051 Telecom GmbH v Bundesrepublik Deutschland

(Case C-453/06)

(2006/C 326/85)

Language of the case: German

Referring court

Bundesverwaltungsgericht (Germany)

Parties to the main proceedings

Applicant: 01051 Telecom GmbH

Defendant: Bundesrepublik Deutschland

Question referred

Is it consistent with the first sentence of Article 27 of Directive
2002/21/EC of the European Parliament [and of the Council] of
7 March 2002 on a common regulatory framework for elec-
tronic communications networks and services
(Framework
Directive) (1) and Article 7 of Directive 2002/19/EC of the Euro-
pean Parliament and of the Council [of 7 March 2002] on
access to, and interconnection of, electronic communications
networks and associated facilities (Access Directive) (2) if, under

national law, a statutory requirement formerly provided for in
that law under which interconnection charges are to be calcu-
lated by reference to the cost of
the efficient provision of
services is to be maintained temporarily, even though there is
no obligation to do so under Community law?

(1) OJ L 108, P.33.
(2) OJ L 108, P.7.

Reference for a preliminary ruling from the Bundesverga-
beamt (Austria) lodged on 13 November 2006 — presse-
text Nachrichtenagentur GmbH v 1. Republic of Austria
(Bund), 2. APA-OTS Originaltext-Service GmbH, 3. APA
AUSTRIA PRESSE AGENTUR, a registered cooperative
with limited liability

(Case C-454/06)

(2006/C 326/86)

Language of the case: German

Referring court

Bundesvergabeamt

Parties to the main proceedings

Applicant: pressetext Nachrichtenagentur GmbH

Respondents: 1. Republic of Austria (Bund), 2. APA-OTS Origi-
naltext-Service GmbH, 3. APA AUSTRIA PRESSE AGENTUR, a
registered cooperative with limited liability

Questions referred

1. Are the terms

‘awarding’

in Article 3(1) of Directive
92/50/EEC (1) and ‘awarded’ in Articles 8 and 9 of that direc-
tive to be interpreted as encompassing circumstances in
which a contracting authority intends to obtain services in
the future from a service provider established as a limited
liability company where those services were previously
supplied by a different service provider who is the sole share-
holder in the future service provider and has control of the
future service provider? In such a case is it legally relevant
that
that
throughout the entire period of the original contract the

contracting authority has no guarantee

the