Point 1. · Proceedings brought by Astellas Pharma GmbH (C-557/16)

Contents

1. Article 28 and Article 29(1) of Directive 2001/83/EC of th…
2. Article 10 of Directive 2001/83, as amended by Directive 2…

1.Article 28 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, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, must be interpreted as meaning that, in a decentralised marketing-authorisation procedure for a generic medicinal product, the competent authority of a Member State concerned by that procedure cannot itself determine the point in time from which the data exclusivity period for the reference medicinal product starts to run when adopting, under Article 28(5) of that directive, its decision on the placing on the market of that generic medicinal product in that Member State.

Proceedings brought by Astellas Pharma GmbH (C-557/16)

Key facts

History · 1 version

Connections