Case C-527/07: Reference for a preliminary ruling from High Court of Justice (England & Wales), Queen's Bench Division (Administrative Court) (United Kingdom) made on 28 November 2007 — Generics (UK) Ltd, Regina v Licensing Authority (acting via the Medicines and Healthcare products Regulatory Agency)
Date: 2007-11-28
Institutions: Court of Justice
Subjects: interpretation of the law, market approval, marketing, medicinal product, pharmaceutical legislation

C 22/36

EN

Official Journal of the European Union

26.1.2008

Reference for a preliminary ruling from High Court of
Justice (England & Wales), Queen's Bench Division (Admin-
istrative Court) (United Kingdom) made on 28 November
2007 — Generics (UK) Ltd, Regina v Licensing Authority
and Healthcare products
(acting via

the Medicines

Regulatory Agency)

(Case C-527/07)

(2008/C 22/64)

Language of the case: English

Referring court

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

(e) a product containing the same active ingredient has
subsequently been authorised under Article 6 of Direc-
tive 2001/83 and placed on the market in the EC;

is the medicinal product to be considered to be ‘a reference
medicinal product which is or has been authorised under
Article 6 … in a Member State’ within the meaning of
Article 10(1) of Directive 2001/83, and if so which of the
above conditions is/are decisive in this respect?

(2) In circumstances where the competent authority of a refer-
ence Member State erroneously refuses an application for a
marketing authorisation made under Article 10(1) of Direc-
tive 2001/83 in the context of the decentralised procedure
provided for in that Directive, on the ground that the medic-
inal product referred to in Question 1 above was not a
‘reference medicinal product’ within the meaning of Article
10(1), what guidance, if any, does the Court of Justice think
it appropriate to provide as to which circumstances the
national court ought to take into consideration when it
comes to determine whether the breach of Community law
is a sufficiently serious breach within the meaning of the
judgment in Brasserie du Pecheur and Factortame?

Parties to the main proceedings

Applicant: Generics (UK) Ltd, Regina

(1) OJ L 214 p. 1.
(2) OJ L 311 p. 67.

Defendant: Licensing Authority (acting via the Medicines and
Healthcare products Regulatory Agency)

Questions referred

(1) Where a medicinal product falling outside the scope of the
Annex to Regulation 2309/93 (1) has been placed on the
(Austria) under its national
market
authorisation procedure prior
that
Member State to the EEA or the EC and:

to the accession of

in a Member State,

(a) that Member State has subsequently acceded to the EEA
and then the EC, and as part of the conditions of its
accession it has transposed into its national
law the
authorisation provisions of Directive 65/65 (now Direc-
tive 2001/83 (2)), no transitional provisions applying in
this respect;

(b) the product in question has remained on the market in
that Member State for some years after its accession to
the EEA and the EC;

(c) following the accession of that Member State to the EEA
and the EE, the marketing authorisation for the product
in question has been varied by adding a new indication,
and the variation was considered by the authorities of
that Member State to be consistent with the require-
ments of Community law;

(d) the dossier of the product in question was not updated
in accordance with Directive 65/65 (now Directive
2001/83) after that Member State's accession to the
EEA and the EC; and

Appeal brought on 29 November 2007 by Association de
la presse internationale ASBL (API) against the judgment of
the Court of First Instance (Grand Chamber) delivered on
12 September 2007 in Case T-36/04: Association de la
presse internationale ASBL (API) v Commission of the
European Communities

(Case C-528/07 P)

(2008/C 22/65)

Language of the case: English

Parties

Appellant: Association de la presse internationale ASBL (API)
(represented by: S. Völcker, Rechtsanwalt, F. Louis, avocat and C.
O'Daly, Solicitor)

Other parties to the proceedings: Commission of the European
Communities