ECAmendment object
Ethical review mandatory for
Any substantial amendments
Responsible for notification of SA
Sponsor
Timeline Ethical review of SA (max nr days)
35
From date of receipt of valid application
Guidance on submission of SA
A guide to the application (including the submission of amendments) is provided on the EPN website in section Application.
Additional Information
Some amendments do only require notification to the CA and a favourable opinion by the EC.
The sponsor ensures that a copy of the EC’s opinion is submitted to the MPA within 15 days after receipt.
