The European Medicines Agency EMA announced that the European Shortages Monitoring Platform (ESMP) started with the full scope of functionalities on 29 January 2025 (which is ahead of the pre-defined deadline on the 2nd of February). All Marketing Authorisation Holders MAHs are obliged now to only use the platform to report data on medicine shortages and availability issues.
In addition to the routine shortage reporting by MAHs of centrally authorised products (CAPs), launched in November 2024, the full scope of functionalities of the ESMP is now available for crisis and MSSG-led preparedness reporting, for both MAHs and national competent authorities (NCAs). EMA collects data via the platform from national competent authorities (NCAs) and marketing authorisation holders (MAHs).MAHs and NCAs will be able to use these functionalities in the event of a public health emergency, major event, or MSSG-led preparedness activity.
The platform enables EMA to monitor the supply, demand and availability of medicines in three scenarios:
When preparing for and reacting to a crisis;
When EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), also known as the Medicine Shortages Steering Group, requests this type of reporting
Under normal circumstances.
See the table below for more details on who reports what product type in which scenario:
Normal circumstances
Routine reporting of shortages of medicinal products.
Who needs to report:
Marketing authorisation holders
Product type:
Centrally authorised products
MSSG-led preparedness
Close monitoring of specific medicine(s) at the request of EMA's Medicine Shortages Steering Group (MSSG). The group creates a specific list of medicines for each action.
Who needs to report:
Marketing authorisation holders
National competent authorities
Product type:
Centrally authorised products
Nationally authorised products
Crisis
Reporting on supply, demand and availability of medicinal products during a public health emergency or major event.
EMA publishes a list of critical medicines it monitors for each particular crisis.
Who needs to report:
Marketing authorisation holders
National competent authorities
Product type:
Centrally authorised products
Nationally authorised products
Platform implementation
Full launch
As of 2 February 2025, MAHs are obliged to use the platform to report data on medicine shortages of centrally authorised products in normal circumstances.
MAHs are also obliged to report data on supply and availability in the following situations:
For MSSG-led preparedness actions - 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 29 January 2025, national competent authorities (NCAs) can submit data in crises or MSSG-led preparedness actions 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 the informational brief available below:
European Shortages Monitoring Platform (ESMP) Informational brief
English (EN) (269.78 KB - PDF)
First published: 11/06/2024
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For more information on EMA's role in addressing medicine shortages, see:
Crisis preparedness and management
Pre-launch for MAHs
As of 28 November 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 2 February 2025.
For shortages that have been reported to EMA before this transition period (28 November 2024 to 2 February 2025), MAHs should continue to use the regular process.
How to access platform
Marketing authorisation holders
As of 28 November 2024, marketing authorisation holders (MAHs) can access the platform and sign in via the link below:
European Shortages Monitoring Platform
MAHs need to have an active EMA user account and an ESMP industry user role to sign in.
A user guide is available for MAHs with related step-by-step instructions. They can find it in the platform and in the 'Guidance and training materials' section on this webpage.
More information is available for MAHs in the recorded training linked below:
European Shortages Monitoring Platform (ESMP) training session on routine shortage reporting for marketing authorisation holders of centrally authorised products (CAPs)
National competent authorities
As of 29 January 2025, national competent authorities (NCAs) can also sign in to report and monitor data in crisis and preparedness scenarios.
NCAs can find step-by-step instructions on how to use the platform in the 'Guidance and training materials' section on this webpage.
A training course for NCAs who have access to the EU Network Training Centre (EU NTC) is available in the following link:
Link to EU NTC course for NCAs about the platform
Guidance and training materials
Guidance and training materials to support ESMP stakeholders in the adoption and use of the platform are available.
EMA updates these documents on a regular basis and their content reflects the status at the time of publication.
To find high-level information on the platform, including how it works, reporting requirements for marketing authorisation holders (MAHs) and national competent authorities (NCAs), and how it can support EMA on human medicine shortages, see:
European Shortages Monitoring Platform (ESMP) essentials: Industry and network reporting requirements
English (EN) (1.49 MB - PDF)
First published: 31/07/2024
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Training for MAHs and NCAs
EMA also publishes training materials directed to MAHs and NCAs. Select the expandable panels to access them.
Stakeholder engagement plan
An overview of all planned communication initiatives is available in the following document:
European Shortages Monitoring Platform (ESMP): Stakeholder engagement plan
English (EN) (243.77 KB - PDF)
First published: 31/07/2024
Last updated: 10/12/2024
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The plan includes initiatives up to the first quarter of 2025.
This is a living document and items may change to meet emerging needs. EMA confirms and communicates dates closer to each initiative.
Events
Throughout 2024 and 2025, EMA will organise events to familiarise relevant stakeholders with the platform.
Select the expandable panel below to find a list of event pages related to ESMP, including video recordings of past events.
EMA carries out public system demonstrations - or demos - to inform and involve stakeholders in the development of the European Shortages Monitoring Platform (ESMP).
Select the expandable panel below for information on how to access the related video recordings.
For information on other events featuring the ESMP, please search via keywords ('ESMP' or 'European shortages monitoring platform') in the events section on EMA's corporate website. There you can look for both upcoming and past events:
Events
Development and milestones of platform
EMA is developing the platform in line with the Scaled Agile Framework (SAFe).
Following an Agile approach means that the platform will start with basic features and EMA will gradually add more over time.
EMA will keep stakeholders up-to-date on the platform's development with informative sessions, technical guidance and public demonstrations.
For more information on SAFe at EMA, see:
Network Portfolio: Agile transformation
The timeline below highlights the key ESMP-related developments and milestones, from the adoption of legislation requiring the platform to the availability of the first version of the platform.
Development and milestones timeline
Adoption of Regulation (EU) 2022/123
First quarter of 2022
Registration of industry single point of contact (i-SPOC) for medicine supply and availability
Third quarter of 2022
For more information on iSPOCs, see Industry contact points for supply and availability of critical medicines.
IT developments and enhancements
From fourth quarter of 2022 to the first quarter of 2025
Interoperability with national and pharmaceutical industry systems
EMA is working to make the platform interoperable with national and pharmaceutical industry systems so that data can be easily exchanged between these systems.
This will help harmonise and simplify monitoring and reporting on medicine shortages in the EU.
While interoperability can reduce the need for user action, users will still be able to manually submit data through the ESMP interface.
An implementation timeline is available below.
Implementation timeline
Definition of technical formats and implementation plan
First quarter of 2024
Detailing of data fields and formats, creation of guidance materials
Second and third quarter of 2024
Start of machine-to-machine solution implementation
Fourth quarter of 2024
Frequently asked questions
Marketing authorisation holders and national competent authorities can find answers to their most frequently asked questions in the document below:
Frequently asked questions on the European Shortages Monitoring Platform (ESMP)
English (EN) (288.68 KB - PDF)
First published: 31/07/2024
Last updated: 10/12/2024
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Contact
For more information and related questions, you can contact EMA through our AskEMA portal:
Send a question to the European Medicines Agency
Related documents
European Shortages Monitoring Platform (ESMP) release notes
English (EN) (284.74 KB - PDF)
First published: 28/11/2024
Last updated: 29/01/2025
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Related content
Executive Steering Group on Shortages and Safety of Medicinal Products
Medicine Shortages Single Point of Contact (SPOC) Working Party
Crisis preparedness and management
Availability of medicines before and during crises
