CATimelineAuthorisation object
60
Explicit (written)
90
NB! The HPRA strongly recommends that the applicant requests a pre-submission meeting to discuss the potential submission in these categories.
Explicit (written)
+ 90
No time limit
Date of receipt of valid application
(Applications are validated on receipt, and start of the procedure is held pending submission of any additional information)
Ad approval procedure:
Once the application is validated, the application is assesed and wtihin 25 days (30 days ATMPs and GMOs), a written notice is sent setting out either acceptance of the request, with conditions if necessary, or grounds for non-acceptance.
If grounds for non-acceptance are sent, the applicant must respond and submit an amended request within 14 days (30 days - or more if HPRA agrees- for ATMP and GMOs). Following assessment of response, and within 60 days (90 days for ATMP and GMOs) of the receipt of the original valid application, a final written notice of the outcome is sent to the applicant.
Timelines for Authorisation procedures are described in detail in the Guide to Clinical Trial Applications, available on the HPRA website in section: Medicines>Regulatory Information>Clinical trials>Clinical Trial Applications.
