CJEU Rules That A Concerned Member State Cannot Determine The Regulatory Data Protection Period Of A Reference Medicinal Product

On 11 December 2017 we reported that Advocate General Bobek had opined in Case C-557/16, Astellas Pharma GmbH, that Concerned Member States (CMS) are co-responsible for marketing authorisations granted under the decentralised procedure (DCP).

This morning, the Court of Justice of the European Union (CJEU) handed down its judgment in the case. The Court ruled that:

• Article 28 and Article 29(1) of Directive 2001/83/EC (the Directive) must be interpreted as meaning that, in the framework of a DCP for the placing on the market of a generic medicinal product, the competent authority of a CMS cannot itself determine the starting point of the regulatory data protection (RDP) period of the reference medicinal product when it adopts its decision on the generic medicinal product in that Member State.