A Shortage Mitigation Plan (SMP) is only as good as the moment you actually need it. Plenty of plans that look complete on paper turn out to be unusable during a real shortage: outdated contact details, no clear ownership, or steps that assume time you simply don't have. This guide starts from usability under pressure, not completeness on paper.
What makes an SMP different from an SPP
A Shortage Prevention Plan is about avoidance. An SMP assumes prevention didn't work and the shortage is already here — the question is no longer "how do we prevent this," but "what do we do now, in what order, and who decides." See our explainer on what a Shortage Prevention Plan involves if you haven't set that up yet.
Step 1: Define the trigger moment
An SMP without a clearly defined starting point gets activated too late. Specify which signals set an SMP in motion: a supplier reporting a production interruption, a stock level dropping below a predetermined threshold, or an official ESMP notification that a shortage has emerged elsewhere in the chain.
Step 2: Assign ownership, not just responsibility
"Regulatory affairs is responsible" isn't ownership — it's a department. A usable SMP names a person, with a backup, for each step in the plan. During an actual shortage, there's no time to work out who's actually in charge.
Step 3: Map alternative sources ahead of time, not during the crisis
This is where an SMP leans on the work you've already done for your SPP and product register: if alternative suppliers, manufacturing sites and any parallel registrations aren't already documented, you'll be finding that information during a crisis — slower, and with more room for error.
Step 4: Define the notification route in advance
Who notifies what, to whom, and within what timeframe? Beyond the statutory notification deadlines (see the 12- and 6-month rule), there's often an internal notification route needed too: to commercial, to medical affairs, and possibly to healthcare providers or patient organisations, depending on how critical the medicine is.
Step 5: Document with an audit trail, not a loose file
An SMP that only exists as a Word document on a shared drive can't show when a decision was made, by whom, or based on what information. For an auditor or regulator, that's a risk in itself — separate from whether the plan is actually good.
Step 6: Rehearse the scenario, at least once a year
A plan that's never been run through discovers its weak points at the worst possible moment. A short tabletop exercise — not a full simulation, just a walkthrough of the steps with the people who own them — surfaces most gaps on its own.
Frequently asked questions
Is an SMP required for every product?
The formal, final text of the CMA hasn't been adopted yet. Based on the current texts and the role of the MSSG, this is expected to be most relevant for products on the Union List of Critical Medicines — not necessarily the entire portfolio.
How long does it take to set up a first SMP?
That depends heavily on how much of the underlying information — product register, supplier overview, vulnerability assessment — is already structured. Teams that already have that in place can often set up a usable first SMP within a few weeks; teams starting from zero need to build that foundation first.