The European Medicines Agency (EMA) is leading a critical initiative to safeguard the availability of medicinal products across the European Union (EU) and the European Economic Area (EEA). The European Shortages Monitoring Platform (ESMP), set to launch in phases starting in late 2024, will provide a comprehensive framework for monitoring supply, demand, and availability of critical medicinal products. This platform is poised to become a cornerstone for ensuring the steady flow of essential medicinal products in both crisis and routine situations.

Purpose of the ESMP

The primary goal of the ESMP is to streamline information exchange among stakeholders, including marketing authorisation holders (MAHs), national competent authorities (NCAs), and the general public. By gathering real-time data on supply of medicinal products, demand, and usage, the platform aims to:

• Prevent shortages: Early detection of supply chain disruptions will enable pre-emptive action.
• Manage crises effectively: Tailored responses during public health emergencies or major events.
• Support routine monitoring: Even in normal circumstances, ESMP will provide a mechanism to track and address potential shortages.

Responsibilities of Marketing Authorisation Holders (MAHs)

MAHs are at the forefront of ensuring the success of the ESMP. As the entities responsible for centrally authorised medicinal products (CAPs), MAHs must report potential or actual shortages in a timely and accurate manner. This responsibility underscores their pivotal role in the supply chain, ensuring patients have uninterrupted access to critical medicinal products.

Reporting Timeline and Transition

1. Pre-launch phase (optional): Starting 28 November 2024, MAHs can voluntarily use the ESMP to report new shortages of CAPs. During this period, they may also continue using the existing reporting
2. Full launch (mandatory): From 2 February 2025, all MAHs must use the ESMP exclusively for reporting shortages and availability issues under the following scenarios:

• Normal circumstances: Routine reporting of CAP shortages.
• Preparedness exercises led by the Medicine Shortages Steering Group (MSSG): Reporting data on medicinal products identified as critical by the MSSG.
• Crisis situations: Comprehensive reporting on both centrally and nationally authorised medicinal products that are listed as critical during the specific crisis.Crisis situations: Comprehensive reporting on both centrally and nationally authorised medicinal products that are listed as critical during the specific crisis.