Of all the obligations coming down on marketing authorisation holders, the notification deadlines are the most concrete — and the least forgiving. This article explains exactly when you need to notify, who to notify, and why these deadlines are longer than most teams are used to.
The two core deadlines
| Situation | Deadline |
|---|---|
| Permanent discontinuation | At least 12 months before discontinuation |
| Temporary interruption | At least 6 months before interruption |
These deadlines originate from the broader EU Pharma Package, which governs notification obligations for MAHs, and are supplemented by the Critical Medicines Act with additional reporting requirements and a stronger role for the European Shortages Monitoring Platform (ESMP).
Why the deadline is so long
Twelve months feels like an eternity to most commercial and supply chain teams — decisions to phase out a product are often made on a much shorter horizon. The underlying logic isn't business operations, it's public health: national authorities and healthcare providers need time to find alternatives, redistribute stock, or in the worst case, procure jointly through the Commission. The more critical the medicine, the greater the importance of early signalling.
Where you notify: the ESMP
Notifications go through the European Shortages Monitoring Platform, the digital tool the EMA is currently expanding to enable faster, more consistent and more data-driven exchange between industry and regulators. An explicit concern addressed in the legislation itself is avoiding duplicate reporting — the same signal doesn't need to be submitted separately to every national authority as well as the ESMP.
What goes wrong if you're late
The formal penalty regimes aren't finalised yet, but the core risk isn't just fines — it's reputation and your relationship with regulators. A late notification:
- Shrinks the time authorities have to respond, increasing the chance of a shortage that patients actually notice.
- Can raise questions at your next audit about the quality of your internal early-warning procedure.
- Undermines the trust that the cooperation duty depends on — sharing information about manufacturing capacity and key suppliers works both ways.
How to track the deadline in practice
Most teams still tracking this in a spreadsheet or shared calendar run into the same problem: the deadline is tied to a decision that doesn't always land on one fixed date — a supplier winding down gradually, a production line being divested. What works:
- Tie the notification deadline to the product in your register, not to a separate project plan.
- Assign explicit ownership — who's responsible for flagging it, and who's responsible for actually filing the notification.
- Build in a buffer: don't plan against the absolute deadline, but against an internal deadline set weeks earlier.
Frequently asked questions
Do these deadlines already apply, or only after the CMA is formally adopted?
The notification obligations come from the broader EU Pharma Package and are largely independent of the final timeline of the CMA itself. The CMA adds further reporting and cooperation obligations once it's formally adopted.
Does the deadline apply per product or per market?
The formal, final text hasn't been adopted yet; based on the current texts, notifications are expected to be relevant per product and per affected Member State, with the ESMP as the central point to avoid duplicate reporting.
Want to know how to build early signalling into your process? Read what a Shortage Prevention Plan involves.