«(Interpretation of Article 28 EC and Article 30 EC – Medicinal products – Withdrawal of parallel import licence in consequence of waiver of the marketing authorisation for the medicinal product of reference)»

Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Medicinal products – Withdrawal of a parallel import licence solely because of the withdrawal of the reference marketing authorisation at the request of the holder – Not permissible – Justification – Protection of public health – Risk to the health of humans as a result of the continued existence of the medicinal product on the market of the Member State concerned (Arts 28 EC and 30 EC) Article 28 EC and Article 30 EC preclude national legislation under which the withdrawal, at the request of its holder, of a marketing authorisation of reference of itself entails the withdrawal of the parallel import licence granted for the medicinal product in question.However, those provisions do not preclude restrictions on parallel imports of the medicinal product in question where there is in fact a risk to the health of humans as a result of the continued existence of that medicinal product on the market of the importing Member State.see para. 34, operative part

JUDGMENT OF THE COURT (Sixth Chamber) 8 May 2003 (1)

((Interpretation of Article 28 EC and Article 30 EC – Medicinal products – Withdrawal of parallel import licence in consequence of waiver of the marketing authorisation for the medicinal product of reference))

In Case C-113/01,

REFERENCE to the Court under Article 234 EC by Högsta förvaltningsdomstolen (Finland) for a preliminary ruling in the proceedings pending before that court brought by

on the interpretation of Article 28 EC and Article 30 EC,

THE COURT (Sixth Chamber),,

composed of: J.-P. Puissochet, President of the Chamber, C. Gulmann (Rapporteur), F. Macken, 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 the Finnish Government, represented by E. Bygglin, of the Danish Government, represented by J. Molde, of the Netherlands Government, represented by J. Bakel, acting as Agent, of the Norwegian Government, represented by T. Nordby, and of the Commission, represented by L. Ström, at the hearing on 10 October 2002,

after hearing the Opinion of the Advocate General at the sitting on 12 December 2002,

gives the following

Community law

National law

2. If Community law imposes restrictions or conditions on the right of a national agency to decide that a marketing authorisation for parallel imports comes to an end in the situation referred to in Question 1, what importance should be accorded to the facts that

3. If, in the situation referred to in Question 1, Articles 28 EC and 30 EC allow it to be found that the marketing authorisation granted for a parallel import has expired, may it be decided that the marketing authorisation for the parallel import expired immediately the original marketing authorisation was withdrawn, without allowing the parallel importer any time to adapt his activity? Do any of the circumstances referred to in Question 2 affect the question whether it may be decided that the marketing authorisation for a parallel import expires immediately?

On those grounds,

THE COURT (Sixth Chamber),

in answer to the questions referred to it by the Högsta förvaltningsdomstolen by order of 8 March 2001, hereby rules:

Puissochet

Gulmann

Macken

Colneric

Cunha Rodrigues

Delivered in open court in Luxembourg on 8 May 2003.

R. Grass

J.-P. Puissochet

Registrar

President of the Sixth Chamber