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