Case C-104/13: Judgment of the Court (Fifth Chamber) of 23 October 2014 (request for a preliminary ruling from the Augstākās Tiesas Senāts — Latvia) — Olainfarm AS v Latvijas Republikas Veselības ministrija, Zāļu valsts aģentūra (Reference for a preliminary ruling — Approximation of laws — Industrial policy — Directive 2001/83/EC — Medicinal products for human use — Article 6 — Marketing authorisation — Article 8(3)(i) — Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials — Derogations relating to pre-clinical tests and clinical trials — Article 10 — Generic medicinal products — Concept of ‘reference medicinal product’  — Whether the holder of a marketing authorisation for a reference medicinal product has an individual right to oppose the marketing authorisation of a generic of the reference product — Article 10(a) — Medicinal products of which the active substances have been in well-established medicinal use within the European Union for at least 10 years — Whether it is possible to use a medicinal product for which authorisation has been granted on the basis of the derogation provided for in Article 10(a) as a reference medicinal product for the purpose of obtaining a marketing authorisation for a generic product)
Date: 2014-10-23
Institutions: Court of Justice
Subjects: generic drug, market approval, public health, scientific research








C_2014439EN.01000302.xml










8.12.2014   


EN


Official Journal of the European Union


C 439/3





Judgment of the Court (Fifth Chamber) of 23 October 2014 (request for a preliminary ruling from the Augstākās Tiesas Senāts — Latvia) — Olainfarm AS v Latvijas Republikas Veselības ministrija, Zāļu valsts aģentūra
(Case C-104/13) (1)

((Reference for a preliminary ruling - Approximation of laws - Industrial policy - Directive 2001/83/EC - Medicinal products for human use - Article 6 - Marketing authorisation - Article 8(3)(i) - Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials - Derogations relating to pre-clinical tests and clinical trials - Article 10 - Generic medicinal products - Concept of ‘reference medicinal product’ - Whether the holder of a marketing authorisation for a reference medicinal product has an individual right to oppose the marketing authorisation of a generic of the reference product - Article 10(a) - Medicinal products of which the active substances have been in well-established medicinal use within the European Union for at least 10 years - Whether it is possible to use a medicinal product for which authorisation has been granted on the basis of the derogation provided for in Article 10(a) as a reference medicinal product for the purpose of obtaining a marketing authorisation for a generic product))
(2014/C 439/04)
Language of the case: Latvian

Referring court

Augstākās Tiesas Senāts

Parties to the main proceedings


Applicant: Olainfarm AS

Defendants: Latvijas Republikas Veselības ministrija, Zāļu valsts aģentūra

Intervening party: Grindeks AS

Operative part of the judgment







1)


The concept of ‘reference medicinal product’ within the meaning of Article 10(2)(a) 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 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007, must be interpreted as encompassing a medicinal product for which the marketing authorisation was granted on the basis of Article 10(a) of the directive.










2)


On a proper construction of Article 10 of Directive 2001/83, as amended by Regulation No 1394/2007, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, the holder of a marketing authorisation for a medicinal product used as a reference product in an application for a marketing authorisation under Article 10 of the directive for a generic product of another manufacturer has the right to a judicial remedy enabling him to challenge the decision of the competent authority which granted the marketing authorisation for the generic product, provided that that holder is seeking judicial protection of a right conferred on him by Article 10. Such a judicial remedy exists, inter alia, where the holder demands that his medicinal product is not to be used for the purpose of obtaining, under Article 10, a marketing authorisation for another medicinal product in relation to which his own product cannot be regarded as a reference product within the meaning of Article 10(2)(a) of the directive.






(1)  OJ C 123, 27.4.2013.