# C_2014439EN.01000302.xml

| 8.12.2014 | EN | Official Journal of the European Union | C 439/3 |
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8.12.2014

EN

Official Journal of the European Union

C 439/3

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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)

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((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

Referring court

Augstākās Tiesas Senāts

Parties to the main proceedings

Parties to the main proceedings

Applicant: Olainfarm AS

Applicant:

Defendants: Latvijas Republikas Veselības ministrija, Zāļu valsts aģentūra

Defendants:

Intervening party: Grindeks AS

Intervening party:

Operative part of the judgment

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. |
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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. |
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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.

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(1)  OJ C 123, 27.4.2013.

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