CASubmissionOfApplication object

Responsible for study submission

Sponsor

Guidance on submission of application available

Yes

Guidance on submission of application

A detailed guidance for trial submission is provided on the CA website in "Guideline for applications for authorisation of clinical trials of medicinal products in humans".

Additional Information

The sponsor must also notify the manufacturer of the IMP of the application at the same time of the application to the CA (pursuant to Section 88(5) Danish Medicines Act (en).)

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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