Case C-452/06
The Queen, on the application of:
Synthon BV
v
Licensing Authority of the Department of Health
(Reference for a preliminary ruling from the High Court of Justice of
England and Wales, Queen’s Bench Division (Administrative Court))
(Community code relating to medicinal products for human use – Marketing authorisation – Essentially similar medicinal products – Abridged procedure – Procedure for mutual recognition – Grounds for refusal – Liability of a Member State – Serious breach of Community law)
Summary of the Judgment
1.Approximation of laws – Medicinal products – Marketing authorisation – Application for mutual recognition
(European Parliament and Council Directive 2001/83, Arts 10(1), 28 and 29)
2.Approximation of laws – Medicinal products – Marketing authorisation – Application for mutual recognition
(European Parliament and Council Directive 2001/83, Arts 10(1), 28 and 29)
1.Article 28 of Directive 2001/83 on the Community code relating to medicinal products for human use precludes a Member State to which an application is made for mutual recognition of a marketing authorisation of a medicinal product for human use granted by another Member State under the abridged procedure provided for in Article 10(1)(a)(iii) of that directive from refusing that application on the ground that the medicinal product in question is not essentially similar to the reference product.
It is clear from the wording of Article 28(4) of Directive 2001/83 that the existence of a risk to public health, within the meaning of Article 29(1) of that directive, constitutes the only ground that a Member State is entitled to rely on to object to the recognition of a marketing authorisation granted by another Member State. In addition, a Member State wishing to rely on such a ground is required to comply with a specifically prescribed procedure for provision of information, concerted action, and arbitration laid down in Article 29 of Directive 2001/83.
(see paras 28, 33, operative part 1)
2.If, however, a Member State is not called upon to make any legislative choices and has only considerably reduced, or even no, discretion, the mere infringement of Community law may be sufficient to establish the existence of a sufficiently serious breach of Community law. Article 28 of Directive 2001/83, on the Community code relating to medicinal products for human use, confers on the Member State in receipt of an application for mutual recognition only a very limited discretion in relation to the reasons for which that Member State is entitled to refuse to recognise the marketing authorisation in question. In particular, as regards any assessment going beyond the verification of the validity of the application with regard to the conditions laid down in Article 28, the Member State concerned, except where there is a risk to public health, must rely on the assessments and scientific evaluations carried out by the reference Member State.
Thus, the failure on the part of a Member State to recognise, pursuant to Article 28, a marketing authorisation of a medicinal product for human use granted by another Member State under the abridged procedure provided for in Article 10(1)(a)(iii) of that directive, on the ground that the relevant medicinal product either is not essentially similar to the reference product or belongs to a category of medicinal products for which the Member State concerned has a general policy which does not allow it to be considered as essentially similar, constitutes a sufficiently serious breach of Community law, capable of rendering that Member State liable in damages.
(see paras 38, 41, 46, operative part 2)