CASubmissionOfApplication object

Responsible for study submission

Sponsor
Legal representative domiciled in the EU/EEA

Guidance on submission of application available

Yes

Guidance on submission of application

Clinical trials for medicines: apply for authorisation in the UK

National legal framework in place

Yes

Applicable national legal framework/ Reference

The procedure of the applications and the required documents are described in Part 3 of the Medicines for Human Use (Clinical Trials) Regulations 2004.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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