European Shortages Monitoring Platform (ESMP): Guidance, training materials and events

The European Medicines Agency (EMA) provides guidance and training materials to help stakeholders of the European Shortages Monitoring Platform (ESMP) adopt and use the platform. EMA also organises events to support them and facilitate their involvement in the platform’s development.

EMA updates guidance and training materials related to the platform on a regular basis. The content of these documents 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:

For more information, see:

How to fulfil reporting obligations via ESMP

EMA makes available factsheets for a quick and comprehensive overview of reporting obligations for different scenarios. They contain information for:

  • Marketing authorisation holders (MAHs) on routine reporting of shortages and availability under normal circumstances;

  • MAHs and national competent authorities (NCAs) on reporting during crisis and preparedness situations.

Select the expandable panels below to find the factsheets.

Training for marketing authorisation holders

EMA makes available training materials for marketing authorisation holders (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.

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

 

Guidance is available to ensure submissions pass validation checks:

 

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

Training for national competent authorities

EMA also makes available training materials and recordings of trainings to national competent authorities (NCAs).

Select the expandable panels below to access them.

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

 

Guidance is available to ensure submissions pass validation checks:

 

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

ESMP 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.

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.

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:

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