CATimelineAuthorisation object
60
Explicit (written)
In case of positive outcome, CA issues “Letter of no objection”
Date of receipt of valid application
Timelines for the review procedure are described in ‘Guide for Manufacturers and Sponsors on Clinical Investigations Carried out in Ireland’, available on the HPRA website in section: About us>Publications&Forms>Guidance Documents.
ad Approval procedure: Applications are validated on receipt, and start of the procedure is held pending submission of any additional information. Once validated, HPRA provides an initial 30-day review. Further information may be requested from the manufacturer. Response must be submitted within 14 days. The manufacturer will be notified of the outcome by day 60.
NB: The final opinion of the Ethics Committee must be submitted to the HPRA prior to the HPRA finalising its review (and prior to commencement of the investigation).
