EMA Shortage Prevention Plans: What Article 117 Now Requires

For the first time, the European Medicines Agency has published guidance that tells marketing authorisation holders exactly how to build a Shortage Prevention Plan under the new EU pharmaceutical legislation. The guidance, EMA/160238/2026, dated 17 July 2026 and web-published in August, turns a broad legal obligation into a concrete, template-driven deliverable. If you hold a marketing authorisation for a prescription medicine in the EU, an SPP is no longer optional and it is no longer vague. This guide explains what Article 117 now requires, what goes in the plan, and the two-day rule that makes readiness, not paperwork, the real test.

Executive summary

An SPP is a proactive plan to keep a medicine supplied, held ready and produced on request within two days. Article 117(1) of the new Pharmaceutical Regulation requires every marketing authorisation holder to establish and maintain an up-to-date shortage prevention plan for any medicinal product subject to medical prescription, plus any product the European Commission identifies under Article 126(2b). The plan must contain the minimum set of information in Part V of Annex IV. You do not submit it routinely. Instead, EMA, a national competent authority, or the Commission can request it, and you then have two days to provide a current copy.

The practical message is simple. The SPP is a quality system artefact, not an administrative form, and its value is measured by how quickly you can produce a complete, accurate plan under pressure. EMA words the legal readiness deadline as expected from mid-2027, and a revision of the related shortage mitigation plan guidance is planned for the fourth quarter of 2026, so the smart move is to build the capability now.

What is a Shortage Prevention Plan?

What it is: an SPP is a documented, product-specific plan that identifies the risks to continuous supply of a medicine and sets out the measures to prevent a shortage. Why it matters: it moves shortage management from reaction to prevention and gives regulators a fast window into your supply chain resilience. What to do: create and maintain an SPP for every in-scope product, sized to the risk, and keep it current.

The European Medicines Regulatory Network, made up of EMA and the national competent authorities, has monitored medicine availability since 2016. Regulation (EU) 2022/123 reinforced that work and created the Executive Steering Group on Shortages and Safety of Medicinal Products and the Single Point of Contact Working Party. The new pharmaceutical legislation takes the next step by making a prevention plan a standing obligation for marketing authorisation holders, rather than something regulators assemble after a shortage has already started.

Who needs an SPP, and when

What it is: the obligation covers marketing authorisation holders of prescription medicines in the EU, and any product the Commission adds under Article 126(2b). Why it matters: the scope is broad and can grow at the Commission's discretion. What to do: map your EU portfolio now and confirm which products are in scope, because most prescription products will be.

Article 117(1) fixes the baseline scope at all medicinal products subject to medical prescription. The Commission may extend it to further products under Article 126(2b), for example medicines it judges critical. In practice, if you hold prescription marketing authorisations in the EU or EEA, you should plan on needing an SPP for each of them. The plan also supports the separate, standing obligation in Article 56(3) of the new Pharmaceutical Directive to ensure, within the limits of your responsibilities, an adequate and continuous supply of your medicine.

The legal basis, in plain terms

Three instruments work together. Understanding which one drives which obligation keeps your plan defensible.

During a crisis, EMA may request SPPs for medicines on the critical list under Article 9(2)(c) and Article 9(3)(k) of Regulation (EU) 2022/123, and holders submit that information under Article 10(2). At a minimum in that scenario, the Regulation calls for information on production and supply capacity, approved production sites for the finished product and the active substances, potential alternative production sites, and minimum stock levels. The new Article 117 obligation builds on the same logic but applies in normal times, not only in a crisis.

The minimum data set

What it is: Part V of Annex IV sets the minimum set of information for every SPP, and EMA reproduces it as a template in the annex to its guidance. Why it matters: the template defines the floor, so a plan that omits an element is incomplete. What to do: build your plan on the EMA template so the required fields are captured from the start.

The guidance carries an SPP template as Annex I, giving the minimum set of information a holder must be able to produce. Drawing on the statutory minimum and the crisis-request minimum in Regulation (EU) 2022/123, an SPP should be able to show the following.

• Product identification, including the active substance, strength, form and the markets supplied.
• Production and supply capacity for the finished product and the active substance.
• Approved production sites for the finished product and the active substances, and any potential alternative sites.
• Minimum stock levels held along the supply chain.
• A supply chain risk assessment identifying single points of failure and vulnerable inputs.
• The prevention and mitigation measures matched to the identified risks.

The two-day rule that changes everything

What it is: you do not routinely submit SPPs, but when EMA, a national competent authority, or the Commission requests one, you have two days to provide a current copy. Why it matters: readiness, not authoring, is the compliance test. What to do: keep every SPP current and retrievable so a two-day request never catches you assembling data from scratch.

This is the operational heart of the guidance. Because plans are provided on request within two days, an out-of-date or half-built SPP is effectively a non-compliant one. You cannot build a credible supply chain risk assessment in 48 hours. EMA also allows you to group SPPs for medicines that share a common supply chain, at your discretion, as long as the minimum data set can still be made available within two days of a request. Grouping saves effort, but it does not lower the retrievability bar.

Proportionate to risk

The guidance is explicit that the degree of effort, formalisation and documentation for each SPP, and the mitigating measures it proposes, should be proportionate to the identified level of risk for the medicine. A sole-source product with a single active substance supplier and thin stock cover warrants a deeper plan than a multi-source product with resilient inventory. This risk-based approach mirrors the thinking behind good manufacturing practice and pharmaceutical quality systems, so a holder with a mature quality system already has the foundations. The key is to document the risk judgement, not just the conclusion.

In practice, three inputs usually decide the risk tier for a medicine: how many qualified sources exist for the active substance, how much finished product inventory sits in the chain, and how quickly an alternative site could be brought online. A product with a single active substance supplier, weeks rather than months of cover, and no qualified alternative site is high risk and deserves a detailed plan with concrete mitigations. A product with dual sourcing, healthy stock and a validated backup site is lower risk and can carry a lighter plan. Documenting why you placed a product in a given tier is as important as the tier itself, because a reviewer will test the judgement, not just the label.

EU and Canada compared

Companies that supply both markets should not assume the two regimes line up. Canada regulates shortages through its own Food and Drug Regulations framework, which is built around mandatory reporting of an actual or anticipated shortage on a public website, rather than a standing prevention plan held for request. Our guide to Canada's drug shortage regulations sets out that regime in detail. The EU SPP obligation is a different instrument in a different jurisdiction, so a plan built for one does not satisfy the other.

SPP compliance checklist

• An inventory of every in-scope EU prescription product, confirmed against your marketing authorisations.
• An SPP for each product, built on the EMA Annex I template with the Part V of Annex IV minimum data set.
• A documented supply chain risk assessment covering finished product, active substances and key inputs.
• Approved and potential alternative production sites recorded for finished product and active substances.
• Minimum stock levels defined and monitored along the chain.
• Prevention and mitigation measures matched to each identified risk, proportionate to its severity.
• A retrievability test that proves you can produce a current SPP within two days of a request.
• An owner and a review cycle that keeps each SPP up to date as the supply chain changes.
• A link between the SPP and the annual product quality review, so the plan stays live.

Common mistakes

• Treating the SPP as a one-time form. It must be kept up to date, and a stale plan fails the two-day test.
• Waiting for a request to start. You cannot build a real risk assessment in two days, so the work has to be done in advance.
• Applying one depth to every product. The plan must be proportionate to each product's risk, not a single template filled identically.
• Ignoring the active substance supply chain. Sites and capacity for the active substance are part of the minimum data set.
• Assuming a Canadian or other plan will do. The EU SPP is a distinct obligation with its own data set and its own trigger.

Frequently asked questions

What is a Shortage Prevention Plan under Article 117?

It is a product-specific plan that a marketing authorisation holder must establish and keep up to date to prevent a shortage of a prescription medicine. Article 117(1) of the new Pharmaceutical Regulation requires it, and the plan must contain the minimum information set out in Part V of Annex IV.

Which medicines need an SPP in the EU?

All medicinal products subject to medical prescription need one, plus any product the European Commission identifies under Article 126(2b). The scope can be extended at the Commission's discretion, so most prescription products should be treated as in scope.

How quickly must I provide an SPP to EMA?

Within two days of a request. You do not submit SPPs routinely, but EMA, a national competent authority, or the Commission can request one, and you must provide a current copy within two days. That is why the plan must be kept ready at all times.

Do I have to submit the SPP with my marketing authorisation?

No. The SPP is maintained by the holder and provided on request, not filed routinely as part of the authorisation dossier. The obligation is to have it, keep it current, and be able to hand it over within two days.

Can I group SPPs for several products?

Yes, for medicines that share a common supply chain, at your discretion, provided the minimum data set for each can still be made available within two days of a request. Grouping reduces duplication but does not relax the two-day retrievability requirement.

When does the SPP obligation take effect?

EMA describes the legal readiness deadline as expected from mid-2027 under the new pharmaceutical legislation. Because building credible plans takes time and the related shortage mitigation plan guidance is due for revision in the fourth quarter of 2026, holders should start now rather than wait for the deadline.

How MFLRC can help

MFLRC helps marketing authorisation holders turn the Article 117 obligation into a working capability. We build supply chain risk assessments, author SPPs on the EMA template, and fold plan maintenance into your pharmaceutical quality system and annual product quality review so the two-day test is never a scramble. Because active substance sourcing is central to the data set, our supplier qualification and risk-tiering work fits directly alongside SPP development, as do our regulatory affairs, licensing and import and export services for cross-border portfolios.

Not sure which of your products are in scope, or whether your plans would survive a two-day request? Book a consultation and we will assess your portfolio and build a readiness plan tailored to your supply chain.

Conclusion

The EMA Shortage Prevention Plan guidance turns a broad legal duty into a specific, testable deliverable. The obligation is standing, the data set is defined, and the two-day request rule means the plan must be genuinely ready, not just written. Holders who build risk-based, current SPPs on the EMA template, and connect them to their quality system, will meet the mid-2027 expectation with room to spare. Those who wait for the first request will find that two days is not nearly enough time.

Sources and references

• Guidance for industry on implementing Shortage Prevention Plans (SPP), EMA/160238/2026, European Medicines Agency
• Medicine shortages and availability issues, guidance for companies, European Medicines Agency
• Medicine Shortage Prevention Plan template, European Medicines Agency
• Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency, EUR-Lex