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National medicine regulatory authorities

In the European legislative framework, the approval of clinical trial applications is the responsibility of the member states. The national competent authorities and the ethics committees are responsible for authorising a clinical trial taking place in the member state. Also, the national competent authorities are responsible for entering protocol related information that has been submitted to their member state into the EudraCT database. The authorities also add to this information the authorisation of the clinical trial and the opinion from the relevant ethics committee. Once entered, a sub-set of this information is displayed through the EU clinical trials register website.

Version of the website

EU Clinical Trials Register version 2.2

 

See also:

Glossary PDF document

How to search PDF document

FAQs PDF document

Patients’ and Consumers’ Organisations’ contact information PDF document

Healthcare Professionals’ Organisations contact information PDF document

Sponsors' contact information PDF document

Clarification note on the date of registration in the register PDF document

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