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Judgment of the Court (Eighth Chamber) of 27 September 2007. # Commission of the European Communities v Czech Republic. # 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. # Case C-117/07.
ECLI:EU:C:2007:565
62007CJ0117
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(Case C‑117/07)
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 such medicinal products – Failure to transpose within the prescribed period
Actions for failure to fulfil obligations – Examination of merits by the Court – Situation to be taken into consideration – Situation on expiry of the period laid down in the reasoned opinion (Art. 226 EC) (see para. 6)
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
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.