Module 12 Presentations

European Shortages Monitoring Platform (ESMP)

• Outside EMA’s Product Lifecycle Management valuestream, an important EMA topic is Shortages

• Article 13 of Regulation 2022/123 foresees the development of an IT platform to collect information on shortages, supply, and demand for medicinal products, incl. information on marketing status and marketing cessations , from both Industry’s and Member States. → to be implemented Feb 2nd, 2025

• Scope: monitoring, prevention and management

Today

From 2025

Shortages of medicinal products (on the critical medicines lists) during a public health emergency (PHE) or a major event (ME) Actual and potential medicines shortages (in a given Member State), that can lead to a Major event or a PHE

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SharePoint based interim solution

Examples: COVID-19 vaccines, Amoxicillin

ESMP Platform

With ESMP, EMA ensures Crisis Preparedness by monitoring and addressing potential shortages. As well as having a crisis response due to reporting

Manage potential PHEs/MEs

Monitor potential PHEs/MEs

Understand the reasons why MAHs were non-compliant

Prevent shortages of medicinal supplies

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obligations on critical medicines by MAHs

Manage supply and availability of medicinal products

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12