CAAmendment object

Authorisation mandatory for

Any substantial amendments

Responsible for submission of SA


Timeline for approval of SA (max nr days)

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)

Applicable national legal framework/ Reference

Chapter X Art 19 Law 7 May 2004