ECAmendment object

Ethical review mandatory for

Any substantial amendments (concerning investigator, trial site, informed consent)

Responsible for notification of SA


Guidance on submission of SA

Circular letter 575 provides guidance on the submission and characterization of amendments to the EC
(available on the FAMPH 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

Additional Information

The investigator must notify the EC concerned on the content and reasons of any substantial amendments planned