14.9.2015

Official Journal of the European Union

C 302/3

(Joined Cases C-544/13 and C-545/13) (1)

((Reference for a preliminary ruling - Medicinal products for human use - Directive 2001/83/EC - Scope - Articles 2(1) and 3, points 1 and 2 - Medicinal products prepared industrially or manufactured by a method involving an industrial process - Exceptions - Medicinal products prepared in a pharmacy in accordance with a medical prescription for an individual patient - Medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question - Directive 2005/29/EC))

(2015/C 302/03)

Language of the case: Swedish

Referring court

Parties to the main proceedings

Applicant: Abcur AB

Defendant: Apoteket Farmaci AB (C-544/13), Apoteket AB and Apoteket Farmaci AB (C-545/13)

Operative part of the judgment

1.Medicinal products for human use, such as those at issue in the main proceedings, issued in accordance with a medical prescription and for which no marketing authorisation has been granted by the competent authorities in a Member State or pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing an European Medicines Agency fall within the scope of 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, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, by virtue of Article 2(1) thereof, if they have been prepared industrially or manufactured by a method involving an industrial process. Those medicinal products are covered by the exception referred to in Article 3, point 1, of that directive, as amended, only if they have been prepared in accordance with a medical prescription issued before their preparation, which must be specifically for a previously identified patient. Those medicinal products are covered by the exception referred to in Article 3, point 2, of Directive 2001/83, as amended by Directive 2004/27, only if they are delivered directly to patients supplied by the pharmacy which prepared them. It is for the referring court to ascertain whether the conditions for application of those provisions are satisfied in the main proceedings;

2.Even where medicinal products for human use, such as those at issue in the main proceedings, fall within the scope of Directive 2001/83, as amended by Directive 2004/27, advertising practices relating to those medicinal products, such as those alleged in the main proceedings, can also fall within the scope of Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council, provided that the conditions for application of that directive are satisfied.

(1) OJ C 15, 18.1.2014.