Sentencia del Tribunal de Justicia (Sala Sexta), de 29 de abril de 2004, en el asunto C-106/01 [petición de decisión prejudicial planteada por la Court of Appeal (England and Wales) (Civil Division)]: The Queen, a instancia de: Novartis Pharmaceuticals UK Ltd contra The licensing Authority established by the Medicines Act 1968 (representada por The Medicines Control Agency), con intervención de: SangStat UK Ltd e Imtix-SangStat UK Ltd («Medicamentos — Autorización de comercialización — Procedimiento relativo a productos esencialmente similares»)

• Jurisdiction: European Union
• Published date: 30 April 2004
• Celex Number: C2004/118/13

30.4.2004 EN Official Journal of the European Union C 118/7

---

JUDGMENT OF THE COURT

(Sixth Chamber)

of 29 April 2004

in Case C-106/01 (reference for a preliminary ruling from the Court of Appeal (Civil Division) (England and Wales)): The Queen, on the application of Novartis Pharmaceuticals UK Ltd v The Licensing Authority established by the Medicines Act 1968 (acting by the Medicines Control Agency), and SangStat UK Ltd, and Imtix-SangStat UK Ltd (1)

(Medicinal products - Marketing authorisation - Procedure relating to essentially similar products)

(2004/C 118/13)

Language of the case: English

In Case C-106/01: reference to the Court under Article 234 EC from the Court of Appeal (Civil Division) (England and Wales) for a preliminary ruling in the proceedings pending before that court between The Queen on the application of Novartis Pharmaceuticals UK Ltd andThe Licensing Authority established by the Medicines Act 1968 (acting by the Medicines Control Agency), and SangStat UK Ltd, and Imtix-SangStat UK Ltd — on the interpretation of Article 4.8(a) of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ, English Special Edition 1965-1966, p. 20), as amended by Council Directives 87/21/EEC of 22 December 1986 (OJ 1987 L 15, p. 36), 89/341/EEC of 3 May 1989 (OJ 1989 L 142, p. 11) and 93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22) — the Court (Sixth Chamber), composed of: V. Skouris, acting for the President of the Sixth Chamber, C. Gulmann (Rapporteur), J.-N. Cunha Rodrigues, J.-P. Puissochet and R. Schintgen, Judges; F.G. Jacobs, Advocate General; M.-F. Contet, Principal Administrator, for the Registrar, has given a judgment on 29 April 2004, in which it has ruled:

1. Products cannot be regarded as essentially similar for the purposes of the application of Article 4.8(a)(i) or (iii) of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended by Council Directives 87/21/EEC of 22 December 1986, 89/341/EEC of 3 May 1989, and 93/39/EEC of 14 June 1993, where they are not bioequivalent.

2. For the purposes of the procedure laid down by Article 4.8(a)(i) and (iii) of Directive 65/65, as amended, in...