CASubmissionOfApplication object

Sponsor
Legal representative

A detailed guidance for sponsors entitled “Guide to Clinical Trial Applications” is available on the HPRA website in section: Medicines>Regulatory Information>Clinical trials>Clinical Trial Applications (www.hpra.ie). It covers in detail the legal framework, the submission procedure and all other relevant requirements on amendments, safety reporting and trial termination.

Regulation 14 SI 190/2004
Applications should comply with the European Commission’s guideline (CT-1).

NB! Clinical trials meeting dates:
The Clinical Trials Sub-committee of HPRA meets monthly to review all clinical trial applications. The list of monthly cut-off dates are published on the HPRA website in section: Medicines>Regulatory Information>Clinical trials>Clinical Trial Applications (www.hpra.ie). Applications submitted at any stage over the month before 5:00 pm on the cut-off date will be reviewed at the subsequent CT Sub-committee meeting.

GMO:
If any product used in the trial is a genetically-modified organism, a separate application for a licence must be made to the Environmental Protection Agency. A copy of the licence from the agency should be provided with the clinical trial application.Information on clinical trials using medicinal products containing genetically-modified organisms is available from the Environmental Protection Agency (see ‘GMO Part B Deliberate Release’)


Voluntary Harmonisation Procedure: A sponsor may also use the VHP process for multinational trials involving Ireland. In this case detailed information on the process and requirements is provided in ‘Guidance document for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications’ on the HMA website (www.hma.eu).