27.4.2013

Official Journal of the European Union

C 123/13

(Case C-104/13)

2013/C 123/20

Language of the case: Latvian

Referring court

Parties to the main proceedings

Applicant: AS ‘Olainfarm’

Defendants: Latvijas Republikas Veselības ministrija, Zāļu valsts aģentūra

Intervener: AS ‘Grindeks’

Questions referred

1.On a proper construction of Article 10 or of any other provision of Directive 2001/83/EC (1) of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, has the manufacturer of a reference medicinal product an individual right to bring an action challenging the decision of a competent authority by which a generic medicinal product of another manufacturer of medicinal products was registered, using as the reference medicinal product the product registered by the manufacturer of the reference medicinal product? In other words, does that Directive confer on the manufacturer of the reference medicinal product the right to a judicial remedy, the object of which is to determine whether the manufacturer of the generic medicinal product made lawful, well-founded reference to the product registered by the manufacturer of the reference medicinal product, relying on Article 10 of the Directive?

2.If the reply to the first question should be affirmative, on a proper construction of Articles 10 and 10a of the Directive, may a medicinal product registered in accordance with Article 10a of the Directive as a medicinal product in well-established medicinal use be used as a reference medicinal product for the purpose of Article 10(2)(a)?

Language of the case: Latvian

(1) OJ 2001 L 311, p. 67.