«(Medicinal products – Marketing authorisation for a generic medicinal product – Withdrawal of the marketing authorisation for the reference medicinal product – Abridged procedure)»

1.. Approximation of laws – Proprietary medicinal products – Marketing authorisation – Abridged procedure – Essentially similar products – Waiver of the obligation to provide the results of pharmacological and toxicological tests or of clinical trials – Application for a marketing authorisation for a generic medicinal product – Reference medicinal product – Product marketed – Assessment criterion (Council Directive 65/65, Art. 4, third para., point 8, second indent, (a)(iii))

2.. Approximation of laws – Proprietary medicinal products – Marketing authorisation – Abridged procedure – Essentially similar products – Waiver of the obligation to provide the results of pharmacological and toxicological tests or of clinical trials – Application for a marketing authorisation for a generic medicinal product – Reference medicinal product – Necessary for marketing authorisation for that product to be in force at the date of the application (Council Directive 65/65, Art. 4, third para., point 8, second indent, (a)(iii))

JUDGMENT OF THE COURT (Sixth Chamber) 16 October 2003 (1)

((Medicinal products – Marketing authorisation of a generic medicinal product – Withdrawal of the marketing authorisation of the reference medicinal product – Abridged procedure))

In Case C-223/01,

REFERENCE to the Court under Article 234 EC by the Østre Landsret (Denmark) for a preliminary ruling in the proceedings pending before that court between

and

on the interpretation 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 Directive 93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22),

THE COURT (Sixth Chamber),,

composed of: J.-P. Puissochet, President of the Chamber, R. Schintgen, C. Gulmann (Rapporteur), N. Colneric and J.N. Cunha Rodrigues, Judges,

Advocate General: F.G. Jacobs,

after considering the written observations submitted on behalf of:

having regard to the Report for the Hearing,

after hearing the oral observations of AstraZeneca A/S, Generics (UK) Ltd, the Lægemiddelstyrelsen and the Danish Government, the Norwegian Government, the Commission and the EFTA Surveillance Authority at the hearing on 10 October 2002,

after hearing the Opinion of the Advocate General at the sitting on 23 January 2003,

gives the following

Community law

...

National law

On those grounds,

THE COURT (Sixth Chamber),

in answer to the questions referred to it by the Østre Landsret by order of 23 May 2001, amended by order of 6 June 2002, hereby rules:

Puissochet

Schintgen

Gulmann

Colneric

Cunha Rodrigues

Delivered in open court in Luxembourg on 16 October 2003.

R. Grass

V. Skouris

Registrar

President