Case C-452/06: Judgment of the Court (First Chamber) of 16 October 2008 (reference for a preliminary ruling from the High Court of Justice of England and Wales, Queen's Bench Division (Administrative Court) (United Kingdom)) — The Queen, on the application of: Synthon BV v Licensing Authority of the Department of Health (Community code relating to medicinal products for human use — Marketing authorisation — Essentially similar medicinal products — Abridged procedure — Procedure for mutual recognition — Grounds for refusal — Liability of a Member State — Serious breach of Community law)
Date: 2008-10-16
Institutions: Court of Justice
Subjects: interpretation of the law, market approval, medicinal product, mutual recognition principle, pharmaceutical legislation

C 313/4

EN

Official Journal of the European Union

6.12.2008

Judgment of the Court (First Chamber) of 16 October 2008
(reference for a preliminary ruling from the High Court of
Justice of England and Wales, Queen's Bench Division
(Administrative Court) (United Kingdom)) — The Queen,
on the application of: Synthon BV v Licensing Authority of
the Department of Health

relating to medicinal products for human use precludes a Member
State to which an application is made for mutual recognition of a
marketing authorisation of a medicinal product for human use
granted by another Member State under the abridged procedure
provided for in Article 10(1)(a)(iii) of that directive from refusing
that application on the ground that the medicinal product in ques-
tion is not essentially similar to the reference product;

(Case C-452/06) (1)

(Community code relating to medicinal products for human
use — Marketing authorisation — Essentially similar
medicinal products — Abridged procedure — Procedure for
mutual recognition — Grounds for refusal — Liability of a
Member State — Serious breach of Community law)

(2008/C 313/05)

Language of the case: English

Referring court

High Court of Justice of England and Wales, Queen's Bench
Division (Administrative Court)

2. The failure on the part of a Member State to recognise, pursuant to
Article 28 of Directive 2001/83, a marketing authorisation of a
medicinal product for human use granted by another Member State
under the abridged procedure provided for in Article 10(1)(a)(iii) of
that directive, on the ground that the relevant medicinal product
either is not essentially similar to the reference product or belongs
to a category of medicinal products for which the Member State
concerned has a general policy which does not allow it to be consid-
ered as essentially similar, constitutes a sufficiently serious breach of
Community law, capable of rendering that Member State liable in
damages.

(1) OJ C 326, 30.12.2006.

Parties to the main proceedings

Applicant: Synthon BV

Judgment of the Court (Third Chamber) of 16 October
2008 (reference for a preliminary ruling from the Hoge
Raad der Nederlanden, Netherlands) — R.H.H. Renneberg v
Staatssecretaris van Financiën

Defendant: Licensing Authority of the Department of Health

(Case C-527/06) (1)

Interested party: SmithKline Beecham plc

Re:

(Freedom of movement for workers — Article 39 EC — Tax
legislation — Income tax — Determination of the basis of
assessment — National of a Member State receiving all or
almost all of his income in that State — Residence in a
different Member State)

Reference for a preliminary ruling — High Court of Justice of
England and Wales, Queen's Bench Division (Administrative
Court) — Interpretation of Articles 8, 10(1)(a)(iii) and 28 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 (OJ 2001 L 311, p. 67) —
Abridged procedure for obtaining marketing authorisation —
Proprietary medicinal product
to an
authorised product — Refusal
to accept an application for
recognition of marketing authorisation for a medicinal product
granted by another Member State — Obligation to recognise the
authorisation granted by the reference Member State, except
where the procedure laid down by the directive for examining
whether there exists a risk to public health is invoked — Suffi-
ciently serious breach of Community law giving rise to an obli-
gation to redress the damage caused

‘essentially

similar’

Operative part of the judgment

(2008/C 313/06)

Language of the case: Dutch

Referring court

Hoge Raad der Nederlanden

Parties to the main proceedings

Applicant: R.H.H. Renneberg

1. Article 28 of Directive 2001/83/EC of the European Parliament
and of the Council of 6 November 2001 on the Community code

Defendant: Staatssecretaris van Financiën