Revised ESMP: Implementation Guide for Marketing Authorisation Holders

The update ESMP MAH Implementation Guide (v1.5, 28 Apr 2026) defines the technical specifications, data elements, and validation rules marketing authorisation holders must follow to submit and maintain electronic reports to EMA on medicinal-product shortages and related supply/availability information under Regulation (EU) 2022/123. 

It distinguishes routine shortage reporting (shortage details, mitigation, impact, alternatives, additional info) from crisis/MSSG-led preparedness submissions, and relies on pre-populated master data pulled from EMA systems (notably PMS and IRIS) that cannot be edited via ESMP—making accurate, up-to-date upstream records critical for successful submissions. 

Recent updates add readable RMS identifier references, expand allowable shortage start dates back to 01/01/2019, require ISO 3166 alpha‑2 country codes in relevant fields, and enhance manufacturing-site data handling (including retrieval for NAPs from PMS).