European Shortages Monitoring Platform (ESMP) Essentials and Industry Reporting Requirements
In preparation for the first release of ESMP functionalities in Q4 2024, which will launch routine shortage reporting of shortages of centrally authorised products (CAPs) by MAHs among other features that will be used during crises or MSSG-led preparedness activities, EMA aim was to equip marketing authorisation holders with all the essential insights and information needed to navigate the platform effectively when it goes live.
ESMP platform is the new system provided by EMA to handle shortage management processes at the EU/EEA level to report to EMA information on shortages, supply, and demand, according to specific reporting requirements for MAHs.
Futher details are avilable on the ESMP webpage:
- Overview of the ESMP with additional relevant details on different scenarios triggering ESMP data submission.
- Guidance and training materials for both MAHs and NCAs, such as:
- Frequently asked questions on the ESMP;
- MAH ESMP implementation guide;
- Prototype of MAH reporting templates;
- NCA ESMP implementation guide;
- Prototype of NCA reporting templates;
- ESMP Essentials document, with a deep dive on the ESMP, its development, its functionalities for MAHs and NCAs, data elements in scope of ESMP reporting, information on interoperability, and stakeholders’ roles and involvement.
- Stakeholder engagement plan with information regarding upcoming ESMP communications and events which are summarised in the current plan.
Please also note the recent publication of the Union list of critical medicines: XEVMPD/PMS entries to support the prioritisation of product mapping in or with PMS, as announced to the regulatory network and to MAHs in various occasions, e.g., the PMS Info Day organised on 16 April 2024, the ESMP webinar on 24 June 2024, communicated to EudraVigilance users per email on 1 July 2024, and explained in the Public webinar on pack size submissions: from XEVMPD to PMS on 11 July 2024, and to NCAs through dedicated meetings. This mapping will benefit the reporting through ESMP.
More information and the file can be found on the webpage Availability of medicines before and during crises: Union list of critical medicines in the section “Support the implementation of standardised product information in the EU and EEA”.