The authorisation procedure is split into two stages:

1. Part I: a coordinated scientific assessment of the clinical trial application (CTA) by the Reporting Member State (RMS) and all Member States Concerned (MSCs). This is assessed by the Health Products Regulatory Authority (HPRA) in Ireland and for more information click here: https://www.hpra.ie/regulation/human-medicine/clinical-trials/clinical-trials-regulation
2. Part II: an ethical assessment of country-specific and site-specific documents by each MSC according to its own national requirements. Following this procedure, each MSC will reach its own outcome and notify the sponsor through CTIS as to whether the clinical trial is authorised, authorised subject to conditions, or refused.

Part II dossier templates

The following documents are adaptations created by the National Office of templates which were developed and endorsed by the EU Clinical Trials Expert Group (CTEG) to comply with the CTR.

Completion and submission of either the EMA or NREC templates are a mandatory requirement for any Part II dossier submission where Ireland is a Member State Concerned.

• EMA templates linked here
• NREC templates (see table below)

Please note that the Site Suitability Form must be the NREC template, but either EMA or NREC templates are accepted for the remainder of the dossier.

Accessibility of Part II documentation

All documentation submitted for NREC review must be presented in an accessible and searchable format (Word or original PDF). We are unable to accept scanned documents as these documents are composed of images, rather than searchable text, and cannot be optimised for use with assistive software. If it’s not possible to submit an accessible document due to a scanned wet ink signature, an unsigned accessible version must also be included as part of the submission. Submissions that are not in an accessible format may delay the assessment process.