Go-live della nuova piattaforma Europea per segnalare stati di carenze dei medicinali (ESMP) il 28 Novembre 2024
Pre-launch for MAHs
As of November 28, 2024, marketing authorisation holders (MAHs) have the option to use the platform to report new shortages of centrally authorised products (CAPs).
Alternatively, for new CAP shortages, MAHs can still report using the regular process until February 2, 2025.
For shortages that have been reported to EMA before this transition period(November 28, 2024 to February 2, 2025),MAHs should continue to use the regular process.
EMA encourages MAHs to familiarise themselves with the platform before its use becomes mandatory after the transition period.
Full launch
As of February 2, 2025, all MAHs are obliged to only use the platform to report data on medicine shortages and availability issues.
This applies to the following scenarios:
- Normal circumstances
- For MSSG-led preparedness exercises - MAHs must provide data on medicines that the Medicine Shortages Steering Group(MSSG) requested
- During a crisis - MAHs must report data on centrally and nationally authorised medicines which are part of a list of critical medicines created for that specific crisis
As of February 2, 2025, national competent authorities (NCAs) can submit data in crises or MSSG-led preparedness activities related to:
- national demand;
- stock and supply levels;
- patient estimations;
- medicines usage.
To get an overview of the platform, including its scope, objectives and timeline for implementation, consult ESMP webpage on the EMA website.
https://www.ema.europa.eu/en/documents/other/european
-shortages-monitoring-platform-esmp-informational-brief_en.pdf