Article 47 - Right to an effective remedy and to a fair trial
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: