EMA is preparing to collect data via the platform from national competent authorities (NCAs) and marketing authorisation holders (MAHs).
This is in line with EMA's extended mandate, laid out in Regulation (EU) 2022/123.
The platform's first functionalities become available for MAHs in a pre-launch on 28 November 2024.
Its first version becomes available in a full launch on 2 February 2025.
For more information, see:
The platform is being set up to enable EMA to monitor the supply, demand and availability of medicines in three scenarios:
See the table below for more details on who reports what product type in which scenario:
Routine reporting of shortages of medicinal products.
Who needs to report:
Product type:
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 activity.
Who needs to report:
Product type:
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:
Product type:
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.
EMA encourages MAHs to familiarise themselves with the platform before its use becomes mandatory after the transition period.
As of 2 February 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:
As of 2 February 2025, national competent authorities (NCAs) can submit data in crises or MSSG-led preparedness activities related to:
To get an overview of the platform, including its scope, objectives and timeline for implementation, consult the informational brief available below:
For more information on EMA's role in addressing medicine shortages, see:
As of 28 November 2024, marketing authorisation holders (MAHs) can access the platform and sign in via the link below:
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:
As of 2 February 2025, national competent authorities can also sign in to report data in crisis and preparedness scenarios.
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:
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.
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
Development of functionalities for marketing authorisation holders (MAH)
From fourth quarter of 2022 to the first quarter of 2025
Development of functionalities for national competent authorities (NCA)
From first quarter of 2024 to the first quarter of 2025
Interoperability with NCA and MAH systems
From first quarter of 2024 to at least the first quarter of 2025
From implementation plan agreement to deployment
Launch of the first functionalities for routine shortage reporting of CAPs for MAH
28 November 2024
Launch of the first full version of the platform ('minimum viable product')
The 'minimum viable product' includes all the functionalities for MAHs and NCAs, and a public page
February 2025
An overview of all planned communication initiatives to inform, engage and train the main ESMP stakeholders is now available. This includes MAHs, NCAs and general public.
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.
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.
For information on planned publications, see:
MAHs can find step-by-step guidance on access, navigation, and submissions in the platform in the following user guide:
To find high-level information on the platform, including how it works, reporting requirements for MAHs and NCAs, and how it can support EMA on human medicine shortages, see:
MAHs and NCAs can find answers to their most frequently asked questions in the document below:
EMA also publishes training materials directed to MAHs and NCAs. Select the expandable panels to access them.
Throughout 2024 and 2025, EMA will organise events to familiarise relevant stakeholders with the platform:
For more information on upcoming initiatives, see Stakeholder engagement plan.
EMA carries out public system demonstrations - or demos - to inform and involve stakeholders in the development of the European Shortages Monitoring Platform (ESMP).
Information on these demos is available in the table below. Demo video recordings are available by visiting the event pages linked in the table.
| Demo event | Functionalities showcased | Video recording timestamp |
| Quarterly system demo – Q3 2024 (18/09/2024) |
| 00:05:45 |
| Quarterly system demo - Q2 2024 (26/06/2024) |
| 00:25:22 |
| Quarterly system demo - Q1 2024 (26/03/2024) |
| 03:01:45 |
| Quarterly system demo - Q3 2023 (21/09/2023) |
| 00:26:24 |
| Quarterly system demo - Q1 2023 (22/03/2023) | Data elements and upload for MAH bulk submission of shortage information | 2:17:20 |
| Quarterly system demo - Q3 2022 (28/09/2022) | MAH submission of individual shortages (functionality obsolete) | 1:08:53 |
Described functionalities may change over time as the development process is gradual and iterative.
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:
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.
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
First data set available in machine-to-machine solution
First quarter of 2025
All data sets available in machine-to-machine solution, in line with prioritisation
Between second and fourth quarter of 2025
For more information and related questions, you can contact EMA through our AskEMA portal: