# C_2017022EN.01001101.xml

| 23.1.2017 | EN | Official Journal of the European Union | C 22/11 |
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Request for a preliminary ruling from the Korkein hallinto-oikeus (Finland) lodged on 4 November 2016 — Astellas Pharma GmbH

(Case C-557/16)

(2017/C 022/16)

Language of the case: Finnish

Referring court

Korkein hallinto-oikeus

Parties to the main proceedings

Applicant: Astellas Pharma GmbH

Other parties: Helm AG, Lääkealan turvallisuus- ja kehittämiskeskus (Fimea)

Questions referred

| 1. | Are Articles 28(5) and 29(1) 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 to be as interpreted as meaning that the competent authorities of the concerned Member State in the decentralised procedure for marketing authorisations for generic medicinal products in accordance with Article 28(3) of that directive are not themselves competent when issuing a national marketing authorisation to determine the time from which the data exclusivity period for the reference medicinal product begins to run? |
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| 2. | If the answer to the first question is that, when issuing a national marketing authorisation, the competent authorities of a Member State are not competent to determine the time from which the period of data exclusivity of the reference medicinal product starts to run:
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is the court of that Member State when dealing with an appeal by the holder of the marketing authorisation for the reference medicinal product required to determine the time from which the period of data exclusivity starts to run, or is it subject to the same limit as the national authorities of that Member State? —
in those circumstances, how is the national court to give effect to the right of the holder of the marketing authorisation of the reference medicinal product under Article 47 of the Charter of Fundamental Rights of the European Union and Article 10 of Directive 2001/83 to effective legal protection with regard to data exclusivity? —
does the claim for effective legal protection require the national court to examine whether the original marketing authorisation granted in another Member State was issued in accordance with the rules laid down by Directive 2001/83? | — | is the court of that Member State when dealing with an appeal by the holder of the marketing authorisation for the reference medicinal product required to determine the time from which the period of data exclusivity starts to run, or is it subject to the same limit as the national authorities of that Member State? | — | in those circumstances, how is the national court to give effect to the right of the holder of the marketing authorisation of the reference medicinal product under Article 47 of the Charter of Fundamental Rights of the European Union and Article 10 of Directive 2001/83 to effective legal protection with regard to data exclusivity? | — | does the claim for effective legal protection require the national court to examine whether the original marketing authorisation granted in another Member State was issued in accordance with the rules laid down by Directive 2001/83? |
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| — | is the court of that Member State when dealing with an appeal by the holder of the marketing authorisation for the reference medicinal product required to determine the time from which the period of data exclusivity starts to run, or is it subject to the same limit as the national authorities of that Member State? | | | | | | |
| — | in those circumstances, how is the national court to give effect to the right of the holder of the marketing authorisation of the reference medicinal product under Article 47 of the Charter of Fundamental Rights of the European Union and Article 10 of Directive 2001/83 to effective legal protection with regard to data exclusivity? | | | | | | |
| — | does the claim for effective legal protection require the national court to examine whether the original marketing authorisation granted in another Member State was issued in accordance with the rules laid down by Directive 2001/83? | | | | | | |

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

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