CASubmissionOfApplication object

Responsible for study submission


Guidance on submission of application available


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).)