CAAmendment object
Authorisation mandatory for
Any substantial amendments
(as specified in Regulation 21 SI 190/2004)
Responsible for submission of SA
Sponsor
Timeline for approval of SA (max nr days)
35
From date of receipt of valid application
Guidance on submission of SA
The procedure for amendment applications follows the European Commission’s CT-1 guideline, including the process or classification of substantial/non-substantial amendments.
Detailed information on performing national submission for Ireland is provided in the HPRA Guide to Clinical Trial Applications, which is available on the HPRA website in section: Medicines>Regulatory Information>Clinical trials>Clinical Trial Applications.
