Electronic Submissions
This page provides links to all the information needed when submitting electronic submissions for human marketing authorisation applications to the HPRA . We accept and strongly recommend applications be submitted as outlined in the Guide to electronic submissions - human medicines either in eCTD format / non -eCTD (Nees) format or through the Common European Submissions Portal (CESP).
See below the comprehensive list of regulatory activities accepted electronically by the HPRA alternatively please refer to the Common European Submissions Portal (CESP).
| Active Substance master file | Article 45 – Paediatric Submission |
| CAP CHMP copy | Certificate (Free Sale, WHO, GMP) |
| Clinical Trial | Development Safety Update Reports |
| Educational Materials | Extension |
| Follow-up Measure | Herbal MP Application |
| Homeopathic MP Application | Homeopathic National Rules |
| Initial Marketing Authorisation Application | National Variation |
| Notification 61(3) | Paediatric submission, Article 29 |
| Paediatric submission, Article 46 | Periodic Safety Update Report (PSUR) |
| Plasma Master File | Post Authorisation Efficacy Study |
| Post Authorisation Safety Study | Preliminary Assessment Report |
| Referral under Article 29, 30, 31, 35 0r 36 | Reformatting |
| Renewal (yearly or 5-yearly) | Repeat Use Procedure |
| Response DCP – Day 106 | Response List of Questions/Supplemental Info - Initial |
| Response List of Questions/Supplemental Info – PSUR | Response List of Questions/Supplemental Info – Renewal |
| Response List of Questions/Supplemental Info – Transfer | Response List of Questions/Supplemental Info – Variation |
| Risk Management Plan | Scientific and/or Regulatory Advice |
| Specific Obligation | Transfer of a marketing authorisation |
| Urgent Safety Restriction | Variation IA |
| Variation IB | Variation II |
| Withdrawal during assessment or withdrawal of a marketing authorisation | |