Subject of the case
Operative part
Subject of the case
Re:
Failure of a Member State to fulfil obligations – Failure to adopt, within the prescribed period, all the provisions necessary to comply with Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ 2005 L 91, p.13).
Operative part
Operative part
The Court:
1. By failing to adopt, within the prescribed period, the laws, regulations and administrative provisions necessary to comply with Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products, the Czech Republic has failed to fulfil its obligations under A rticle 31(1) of that directive;
2. The Czech Republic is ordered to pay the costs.