CAAmendment object

Notification mandatory for

Any amendments

Authorisation mandatory for

Substantial amendments (as determined by CA)

Guidance on submission of SA available


Guidance on submission of SA

A detailed list of amendments requiring authorisation, notification or none of the two is provided on the website in section: Medicines & medical devices / Medicines regulation / Clinical trials / Trials in humans (5. Amendments to clinical trials)

Further details on submission of amendments are provided on the CA website in Section 11.2 of the 'Guideline for applications for authorisation of clinical trials of medicinal products in humans'.