EMA: FAQs on the European Shortages Monitoring Platform (ESMP)

EMA has updated its FAQ document on the European Shortages Monitoring Platform (ESMP), addressing six new questions – five related to data submission and reporting. 

Key clarifications include:

• To ensure the confidentiality of reporting and considering that an individual performing submissions may be affiliated with multiple marketing authorisation holders, the information is not shown in the users’ submission history. The latest product data is accessible via the submission template for the selected products.
• If no listed root cause fits, users should select “Other” and explain in the free text field. Missing common causes should be reported to the service desk.
• Quality-related shortages must be reported via a quality defect notification, even if the batch isn't on the market.
• ESMP data supports EMA’s risk analysis during crises; preparedness tools will be activated when needed, e.g. ESMP Shortages monitoring and risk analysis tool (SMART).
• There’s no direct link between the Union list of critical medicines and ESMP reporting, but overlaps may occur.

Source:

EMA: Frequently Asked Questions (FAQs) on the European Shortages Monitoring Platform (ESMP)