CELEX: 62007CJ0117
Failure of a Member State to fulfil its obligations
Directive 2005/28/EC
Principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use
Requirements for authorisation of the manufacturing or importation of these medicinal products
Failure to transpose within the prescribed period

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
The Court:

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 Article 31(1) of that directive;

The Czech Republic is ordered to pay the costs.