Case C-527/07: Judgment of the Court (First Chamber) of 18 June 2009 (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 Generics (UK) Ltd v Licensing Authority (acting through the Medicines and Healthcare products Regulatory Agency) (Reference for a preliminary ruling — Directive 2001/83/EC — Medicinal products for human use — Marketing authorisation — Grounds of refusal — Generic medicinal products — Concept of reference medicinal product )
Date: 2009-06-18
Institutions: Court of Justice
Subjects: dual-use good, generic drug, interpretation of the law, judgment of the Court (EU), market approval, marketing, pharmaceutical legislation








C_2009180EN.01000702.xml










1.8.2009   


EN


Official Journal of the European Union


C 180/7





Judgment of the Court (First Chamber) of 18 June 2009 (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 Generics (UK) Ltd v Licensing Authority (acting through the Medicines and Healthcare products Regulatory Agency)
(Case C-527/07) (1)

(Reference for a preliminary ruling - Directive 2001/83/EC - Medicinal products for human use - Marketing authorisation - Grounds of refusal - Generic medicinal products - Concept of ‘reference medicinal product’)
2009/C 180/11
Language of the case: English

Referring court

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

Parties to the main proceedings


Applicant: The Queen, on the application of Generics (UK) Ltd

Defendant: Licensing Authority, acting through the Medicines and Healthcare products Regulatory Agency

Supported by: Shire Pharmaceuticals Ltd, Janssen-Cilag AB

Re:

Reference for a preliminary ruling — High Court of Justice of England and Wales, Queen’s Bench Division (Administrative Court) — Interpretation of Article 10(1) 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) — Marketing authorisation — Abridged procedure — Application for authorisation of a generic of a reference medicinal product — Concept of reference medicinal product when examining the application

Operative part of the judgment

A medicinal product, such as Nivalin at issue in the main proceedings, which falls outside the scope of 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, and the placing of which on the market in a Member State was not authorised in accordance with the applicable Community law, cannot be considered to be a reference medicinal product within the meaning of Article 10(2)(a) 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, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004.


(1)  OJ C 22, 26.1.2008.