CAAmendment object
Authorisation mandatory for
Any substantial amendments
Responsible for submission of SA
Sponsor
Timeline for approval of SA (max nr days)
28
15 (for monocentric Phase I trials)
Guidance on submission of SA
Further details on submission of amendments are specified in Circular 575 + annexes: 'Application for clinical trials and submissions of substantial amendments' (available on the FAMHP website in section: Human medicines > Medicines > Herbal medicinal products > Research and Development > Clinical trials)