CJEU Case C-557/16 / Opinion

Proceedings brought by Astellas Pharma GmbH
Policy area
Justice, freedom and security
Deciding body type
Court of Justice of the European Union
Deciding body
Advocate General
Type
Opinion
Decision date
07/12/2017
ECLI (European case law identifier)
ECLI:EU:C:2017:957
  • CJEU Case C-557/16 / Opinion

    Key facts of the case:

    Reference for a preliminary ruling — Medicinal products for human use — Marketing authorisation issued for a generic of a reference medicinal product — Decentralised procedure — Powers of the competent authority of the concerned Member State — Judicial review — Determination of the data exclusivity period.

    Outcome of the case:

    In the light of the foregoing, I suggest that the Court respond to the question posed by the Korkein hallinto-oikeus (Supreme Administrative Court, Finland) as follows:

    1. Article 28(5) and Article 29(1) 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 should be interpreted as meaning that the competent authority of the concerned Member State, acting in the decentralised procedure for marketing authorisation for a generic medicinal product, is not competent, when issuing the national marketing authorisation pursuant to Article 28(5) of Directive 2001/83, to determine unilaterally the time from which the data exclusivity period for the reference medicinal product begins to run. However, that authority takes part in that assessment at an earlier stage in the decentralised procedure pursuant to Article 28(3) and (4) of Directive 2001/83. The participation of the competent authority of the concerned Member State in the approval process thus makes that authority co-responsible for the documents approved in that procedure.
    2. The courts of the concerned Member State are competent, when deciding upon an appeal brought by the holder of the marketing authorisation for the reference medicinal product, to review a determination made by the competent authority of the same concerned Member State regarding the time from which the period of data exclusivity starts to run. That national court, however, cannot review the legality of the original marketing authorisation granted in another Member State, as that legality, including under Directive 2001/83, must be assessed in the Member State that issued that initial marketing authorisation.
  • Paragraphs referring to EU Charter (original language)