The European Shortages Monitoring Platform (ESMP) comes up in nearly every conversation about CMA and Pharma Package reporting, but for teams who haven't used it yet, it's not always clear what it actually is or how it fits into an existing notification workflow. This guide covers the practical basics.
What the ESMP is
The ESMP is a digital platform, developed and expanded by the EMA, designed to enable faster, more consistent and more data-driven exchange of shortage-related information between industry and regulators. It's the intended single channel for reporting the kind of notifications covered in our notification deadlines explainer — permanent discontinuations and temporary interruptions of critical medicines.
Who reports, and about what
Marketing authorisation holders are the primary reporting party. What triggers a report, in practice:
- A confirmed decision to permanently discontinue a product, at least 12 months ahead.
- A confirmed or anticipated temporary interruption of supply, at least 6 months ahead where foreseeable.
- Responses to information requests from the Commission or national authorities about manufacturing capacity, sites or key suppliers, as covered by the cooperation duty.
Avoiding duplicate reporting
One of the explicit concerns addressed in the underlying legislation is that a MAH shouldn't have to report the same shortage signal separately to every national authority as well as the ESMP. In practice, until the formal mechanics are published, treat this as a direction of travel rather than a guarantee: many MAHs still maintain parallel national reporting as a precaution while the interoperability between national systems and the ESMP is finalised.
A practical reporting workflow
- Tie the trigger to your product register. A notification obligation should fire automatically from a status change on the product — a supplier confirming a production halt, a decision to discontinue — not from someone remembering to check a calendar.
- Draft before the deadline, not at the deadline. Given the 12- and 6-month windows, there's no reason a notification should be assembled last-minute. Draft it as soon as the underlying decision is confirmed internally.
- Keep an internal record independent of the ESMP submission. For audit purposes, you want your own timestamped record of what was submitted, when, and by whom — not just reliance on the platform's own history.
- Route the same signal internally, in parallel. The same information usually needs to reach commercial, medical affairs, and potentially your Shortage Mitigation Plan process — see how to build a Shortage Mitigation Plan for how that escalation should be structured.
Common friction points
Teams setting up ESMP reporting for the first time tend to hit the same few issues: unclear internal ownership of who actually submits (see our note on ownership vs. responsibility in the SMP guide), notification drafts that live in email threads rather than a system of record, and a disconnect between the product register used for quality purposes and the one that actually needs to drive the notification.
Frequently asked questions
Is the ESMP mandatory yet?
The EMA is actively expanding the ESMP's functionality as part of preparation for both the Pharma Package and the CMA. Reporting expectations already exist under the current shortage-notification framework; the CMA is expected to formalise and extend the platform's role once it is formally adopted.
Do I still need to notify national authorities separately?
Avoiding duplicate reporting between national authorities and the ESMP is explicitly flagged as a design goal in the legislation itself, but the exact mechanics of how that plays out per Member State aren't finalised. Until the formal rules are published, many MAHs continue parallel national reporting as a precaution.
For the deadlines themselves, see the 12- and 6-month rule explained.