18.1.2014   

EN

Official Journal of the European Union

C 15/7

1.

Can a prescription-only medicinal product for human use which is prepared and supplied in the circumstances at issue in the proceedings before the Stockholms tingsrätt (Stockholm District Court), for which no marketing authorisation has been granted by the competent authority in a Member State or pursuant to Regulation (EEC) No 2309/93, (1) be regarded as constituting a medicinal product within the meaning of either Article 3(1) or Article 3(2) of Directive 2001/83 (2) on the Community code relating to medicinal products for human use, in particular where there is another authorised medicinal product with the same active substance, the same dosage and the same form?

2.

If a prescription medicinal product for human use which is prepared and supplied in the circumstances at issue in the proceedings before the Stockholms tingsrätt is covered by Directive 2001/83, can Directive 2005/29 (3) concerning unfair business-to-consumer commercial practices in the internal market be applicable in parallel with Directive 2001/83 in respect of the purported advertising measures?

3.

If a prescription medicinal product for human use which is prepared and supplied in the circumstances at issue in the proceedings before the Stockholms tingsrätt 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 (i) Directive 2006/114 (4) concerning misleading and comparative advertising and/or (ii) Directive 2005/29 concerning unfair business-to-consumer commercial practices?

4.

If Directive 2006/114 concerning misleading and comparative advertising is applicable in accordance with Question 3, under what basic conditions do the measures under consideration before the Stockholms tingsrätt (use or attachment of a product name, product number and ATC 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 and information thereon via an electronic health care ordering service and via an undertakings’ own homepage, supply of information on the medicinal product via a publication issued by a national trade organisation, supply of information on the medicinal product in the Apoteket’s Central Product Register and the associated register (JACA), supply of information on the medicinal product in another national information database for medicinal products (SIL), supply of information via the Apoteket Terminal System (ATS) or similar dispensing system, provision of information on an undertakings own or a competing supplier’s medicinal product in correspondence with doctors’ surgeries and patient organisations, marketing of the medicinal product, measures relating to pharmaceutical checks on the medicinal product and competing medicinal products, failure to notify documented and relevant differences between products, failure to notify the contents of an undertaking’s own medicinal product and the assessment of the medicinal product by the Läkemedelsverket (Swedish Medical Products Agency), failure to inform the health care service of the Läkemedelsverket’s scientific advisory board’s assessment of competing products, to maintain a fixed price level for the medicinal product, to set a validity period of three (3) months for a prescription, to dispense the medicinal product from a pharmacy instead of a competing medicinal product despite the fact that the patient has a prescription for that competing product, and to hinder and prevent market transfers of standardised preparations to the competing medicinal product, including local pharmacies refusing delivery of the competing medicinal product, and application of a fixed price as part of the scheme under which medicines are eligible for subsidies without a prior decision from the national authority) constitute advertising within the meaning of Directive 2006/114?