European Shortages Monitoring Platform (ESMP)

The European Medicines Agency (EMA) has launched the European Shortages Monitoring Platform (ESMP) to gather information about medicine availability, supply and demand in order to prevent, detect, and manage human medicine shortages in the European Union (EU) and European Economic Area (EEA).

EMA collects data via the platform from national competent authorities (NCAs) and marketing authorisation holders (MAHs). 

MAHs of centrally authorised products must use the platform to report medicine shortages regularly.

NCAs and MAHs must submit data on the availability, supply, and demand of medicines in situations that require close monitoring (i.e. crises or preparedness actions).

This is in line with EMA's extended mandate, laid out in Regulation (EU) 2022/123.

For more information on the scope of reporting in particular instances, go to the following section on this page:

• Reporting via ESMP

To access the platform, go to:

• European Shortages Monitoring Platform

To get an overview of the platform, including its scope and objectives consult the informational brief available below:

European Shortages Monitoring Platform (ESMP) Informational brief

For more information, see:

• Crisis preparedness and management
• Medicine shortages and availability issues

Reporting via ESMP

The platform enables EMA to monitor the supply, demand and availability of medicines in three scenarios:

• Under normal circumstances;
• 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. This is often referred to as MSSG-led preparedness;
• When preparing for and reacting to a crisis.

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

  When to report:

  • When MAHs become aware of a potential or actual shortage of one of their products. MAHs must update EMA with new relevant information through the platform as it becomes available

  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

  When to report:

  • When MSSG announces a preparedness action, it defines products in scope and the reporting frequency. EMA notifies MAHs with relevant products before reporting starts.

  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

  When to report:

  • When the European Commission recognises a crisis. MSSG defines products in scope and the reporting frequency. EMA notifies MAHs with products in scope before reporting starts.

  Product type:

  • Centrally authorised products
  • Nationally authorised products

How to access platform

Marketing authorisation holders (MAHs) and national competent authorities (NCAs) can access the platform via the link below:

• European Shortages Monitoring Platform

MAHs and NCAs need to have an active EMA user account and an ESMP user role to sign in.

User guides for MAHs and NCAs are available with step-by-step instructions. Find them in the platform and in the 'Guidance and training materials' section on this webpage.

Select the expandable panel below to find trainings with information on how to set up ESMP user roles for MAHs and NCAs.

Trainings with information on how to set up ESMP user roles

• European Shortages Monitoring Platform (ESMP) training session on routine shortage reporting for marketing authorisation holders of centrally authorised products (CAPs) (20/11/2024)
• European Shortages Monitoring Platform (ESMP) training on crisis and MSSG-led preparedness reporting for marketing authorisation holders (MAHs) (19/02/2025)
• EU Network Training Centre (EU NTC) course for NCAs about the platform (login required)

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

Training for MAHs 

EMA makes available training materials for MAHs. 

EMA also offers recordings of previous trainings for MAHs. These include demonstrations of the platform's functionalities, including:

• how to submit a shortage of a centrally authorised product in normal circumstances and update the submission;
• how to report in crises and MSSG-led preparedness actions.

Select the expandable panels below to access the training materials and the links to the recordings.

Training materials for MAHs

MAHs can find step-by-step guidance on access, navigation, and submissions in the platform in the following user guide:

European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holders

 

Guidance is available to ensure submission pass validation checks:

European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holders

 

Find prototypes of templates the platform generates for submitting data in the following file:

European Shortages Monitoring Platform (ESMP): Marketing authorisation holder reporting templates

Links to recorded trainings for MAHs

To find specific content in a training recording, e.g. shortage management in the EU, the overview of the ESMP, specific ESMP functionalities and reporting processes, hover your mouse over the video timeline.

Alternatively, open the video on YouTube and refer to the timestamps in the description

• European Shortages Monitoring Platform (ESMP) workshop on application programming interface (API) for marketing authorisation holders (MAHs) (24/03/2025)
• European Shortages Monitoring (ESMP) Question and answer clinic for marketing authorisation holders on shortage reporting via ESMP (25/02/2025)
• European Shortages Monitoring Platform (ESMP) training on crisis and MSSG-led preparedness reporting for marketing authorisation holders (MAHs) (19/02/2025)
• European Shortages Monitoring Platform (ESMP) training session on routine shortage reporting for marketing authorisation holders of CAPs (20/11/2024)
• European Shortages Monitoring Platform Essentials and Industry Reporting Requirements (24/06/2024)

Training for NCAs

EMA also makes available training materials and recordings of trainings to NCAs. 

Select the expandable panels below to access them.

Training materials for NCAs

NCAs can find step-by-step guidance on access, navigation, and submissions in the platform in the following user guide:

European Shortages Monitoring Platform (ESMP) User guide for national competent authorities

 

Guidance is available to ensure submission pass validation checks:

European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities

 

Find prototypes of templates the platform generates for submitting data in the following file:

European Shortages Monitoring Platform (ESMP): National competent authority reporting templates

Links to recorded trainings for NCAs

Login is required to access both trainings below.

• EU Network Training Centre (EU NTC) course: NCA API workshop (17/02/2025)
• EU Network Training Centre (EU NTC) course for NCAs about the platform (login required) (30/01/2025)
• European Shortages Monitoring Platform Essentials and Industry Reporting Requirements (24/06/2024)

Stakeholder engagement plan

An overview of all planned communication initiatives is available in the following document:

European Shortages Monitoring Platform (ESMP): Stakeholder engagement plan

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 organises 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.

Full list of ESMP events

• European shortages monitoring platform (ESMP): updates and question and answer (Q&A) clinic for marketing authorisation holders (MAHs) (24/06/2025)
• European Shortages Monitoring Platform (ESMP) workshop on application programming interface (API) for marketing authorisation holders (MAHs) (24/03/2025)
• European Shortages Monitoring (ESMP) - Question and answer clinic for marketing authorisation holders on shortage reporting via ESMP (25/02/2025)
• European Shortages Monitoring Platform (ESMP) training on crisis and MSSG-led preparedness reporting for marketing authorisation holders (MAHs) (19/02/2025)
• European Shortages Monitoring Platform (ESMP) training session on routine shortage reporting for marketing authorisation holders of CAPs (20/11/2024)
• European Shortages Monitoring Platform Essentials and Industry Reporting Requirements (24/06/2024)

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.

Links to public system demonstrations

To find video recordings select the related event pages linked in the table below.

Demo event	Functionalities showcased	Video recording timestamp
Quarterly system demo – Q3 2024 (18/09/2024)	National demand for NCAs Stock and supply for NCAs Patient estimation for NCAs Data analytics platform	00:05:45
Quarterly system demo - Q2 2024 (26/06/2024)	Marketing status for nationally authorised products data submission flow for MAHs Manufacturing information for centrally authorised products data submission flow for MAHs	00:25:22
Quarterly system demo - Q1 2024 (26/03/2024)	User interface design MAH routine reporting of shortages of centrally authorised products Portal for EMA case management of shortages Public health emergency monitoring dashboards for member states	03:01:45
Quarterly system demo - Q3 2023 (21/09/2023)	Template download for marketing authorisation (MAH) holder bulk submission of shortages Submission of alternative substances Embedding marketing status for centrally authorised products Data analytics platform	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:

• 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

1. Adoption of Regulation (EU) 2022/123

   First quarter of 2022

2. 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.

3. IT developments and enhancements

   From fourth quarter of 2022 to the first quarter of 2025

4. Development of functionalities for marketing authorisation holders (MAH)

   From fourth quarter of 2022 to the first quarter of 2025

5. Development of functionalities for national competent authorities (NCA)

   From first quarter of 2024 to the first quarter of 2025

6. 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

7. Launch of the first functionalities for routine shortage reporting of CAPs for MAH

   28 November 2024

8. Launch of the first full version of the platform

   The first full version includes all the functionalities for MAHs and NCAs, and a public page

   29 January 2025

9. Continuous improvements and enhancements of the platform

   From 2025
10. Show more 6 itemsHide 6 items

Interoperability with national and pharmaceutical industry systems

EMA designed the platform with interoperability as a core principle, in line with the European Commission's Interoperability Framework.

The platform's interoperability with the systems from national competent authorities (NCAs) and marketing authorisation holders (MAHs) ensures that data can be easily exchanged between these systems.

This helps harmonise and simplify monitoring and reporting on medicine shortages in the EU.

The platform also uses structured data and controlled terms from Substance, Product, Organisation and Referential (SPOR) master data to ensure consistent reporting and convergence between systems.

For more information on SPOR, see:

• Substance, product, organisation and referential (SPOR) master data

For NCAs and MAHs who already store their data within their internal systems, the platform enables data extraction and direct upload into it. They can still manually submit data through the ESMP interface.

Automation of data submission

EMA is developing a machine-to-machine communication interface to further enhance interoperability and streamline data submission from NCAs and MAHs.

EMA has established a set of rules and protocols to define the framework for stakeholders' systems to interact and share data with the platform. This is also known as an application programming interface (API). 

A document describing the API specifications for MAHs and NCAs is available below.

European shortages monitoring platform (ESMP) API - Instructions to request access for national competent authorities (NCAs) and marketing authorisation holders (MAHs)

European Shortages Monitoring Platform (ESMP) Application Programming Interface (API) specifications

Fields and business rules for the European Shortages Monitoring Platform (ESMP) API datasets

European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for marketing authorisation holders (MAHs) (JSON) (YAML)

European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for national competent authorities (NCAs) (JSON) (YAML)

 

Implementation timeline for the API

An implementation timeline is available below for the API.

1. Definition of technical formats and implementation plan

   First quarter of 2024

2. Detailing of data fields and formats, creation of guidance materials

   Second and third quarter of 2024

3. Start of machine-to-machine solution implementation

   Fourth quarter of 2024

4. First data set available in machine-to-machine solution

   First quarter of 2025
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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)

Contacts

For general questions related to the platform, get in contact through our AskEMA portal:

• Send a question to the European Medicines Agency

To get technical support, please contact us via ServiceNow: 

• EMA Service Desk (ServiceNow)