18.1.2014

Official Journal of the European Union

C 15/6

(Case C-544/13)

2014/C 15/08

Language of the case: Swedish

Referring court

Parties to the main proceedings

Applicant: Abcur AB

Defendant: Apoteket Farmaci AB

Questions referred

1.Can a prescription-only medicinal product for human use which is used only in emergency health care, for which no marketing authorisation has been granted by the competent authority in a Member State or pursuant to Regulation (EEC) No 2309/93, and which is prepared by an operator such as that involved in the proceedings before the Stockholms tingsrätt (Stockholm District Court) and ordered by health care institutions on the conditions material to the case before the Stockholms tingsrätt, be covered by any of the exceptions in Article 3(1) or (2) of Directive 2001/83 on the Community code relating to medicinal products for human use, in particular in a situation where there is another authorised medicinal product with the same active substance, same dosage and same pharmaceutical form?

2.If a prescription-only medicinal product for human use such as that referred to in question 1 is covered by Article 3(1), 3(2) or 5(1) of Directive 2001/83, may legislation on advertising measures for medicinal products be regarded as non-harmonised or are the kind of measures which are purported in this case to constitute advertising governed by Directive 2006/114 concerning misleading and comparative advertising?

3.If Directive 2006/114 concerning misleading and comparative advertising is applicable in accordance with question 2, under what basic conditions do the measures under consideration before the Stockholms tingsrätt (use of a product name, product number and AnatomicTherapeuticChemical code for the medicinal product, application of a fixed price for the medicinal product, supply of information on the medicinal product in the National Substance Register for Medicinal Products (NPL), attachment of an NPL identifier to the medicinal product, dissemination of an information sheet on the medicinal product, supply of the medicinal product via an electronic ordering service for health services and the supply of information on the medicinal product via a publication issued by a national professional organisation) constitute advertising within the meaning of Directive 2006/114?

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1).

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).

Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (OJ 2006 L 376, p. 21).