A Shortage Prevention Plan (SPP) is the proactive counterpart to a Shortage Mitigation Plan: where an SMP describes what you do once a shortage occurs, an SPP describes how you prevent one from happening in the first place. Under the EU Critical Medicines Act and the broader Pharma Package, this is becoming expected practice for critical products — even though the exact formal content isn't settled yet, since the legislation is still at the provisional-political-agreement stage.
The purpose of an SPP
An SPP isn't a paperwork exercise for the filing cabinet. Its purpose is very practical: making sure that, as a marketing authorisation holder, you recognise early warning signals — a supplier struggling with manufacturing issues, a concentrated dependency on a single region, a raw material becoming scarce — before those signals translate into an actual shortage for patients.
What an SPP typically contains
Based on the direction set by the EMA, the MSSG (Medicine Shortages Steering Group) and the broader legislation, an SPP typically consists of the following elements:
- Product register with supply chain. For each critical product: the API supplier, manufacturing site(s), and any alternative sources.
- Vulnerability assessment. A risk assessment based on single-source dependency, concentrated supplier regions, and the methodology the MSSG uses for the Union List of Critical Medicines.
- Rolling forecast. A forward view, typically covering 3 to 6 months, of expected demand and availability, updated periodically.
- Diversification strategy. Concrete steps to reduce dependency on a single supplier or region, with a timeline and ownership.
- Early-warning procedure. Who flags what, to whom, and within what timeframe — including the internal escalation path from SPP to SMP.
SPP versus SMP: the difference in one sentence
A Shortage Prevention Plan is about avoidance: forecasting, diversification, early warning. A Shortage Mitigation Plan is about response: what to do once a shortage actually occurs. They're complementary — a good SPP reduces how often you actually have to activate an SMP, but it doesn't replace it. Read the full step-by-step guide for a Shortage Mitigation Plan if that's where you are right now.
How an SPP relates to existing documentation
For most regulatory affairs and QA teams, an SPP isn't an entirely new document built from scratch — it's a structuring of information that already exists somewhere, scattered across quality dossiers, supplier overviews and internal risk analyses. The challenge is rarely a lack of data; it's the lack of one audit-ready place where that data comes together, has version control, and can be demonstrably kept up to date.
Frequently asked questions
Is an SPP legally required?
The formal, final text of the CMA hasn't been adopted yet. What is clear: the underlying notification obligations from the Pharma Package already apply to MAHs, and every signal points to structured SPPs and SMPs for critical products becoming expected practice once the CMA is formally in force.
How often does an SPP need to be updated?
The rolling forecasts within an SPP typically span 3 to 6 months and are reviewed periodically — not as a one-off exercise, but as an ongoing process.
Want more on the broader context? Read what the Critical Medicines Act means for marketing authorisation holders, or dig into the exact notification deadlines.