Nearly every CMA obligation discussed so far — notification deadlines, vulnerability scoring, SPP/SMP expectations — is scoped, in practice, to a specific list: the Union List of Critical Medicines. If you haven't checked whether your own portfolio sits on it, that's the first thing worth doing before anything else in this series.
What the list actually is
The Union List of Critical Medicines identifies medicines for human use where continuity of supply is considered a priority for EU/EEA health systems. It was first published in December 2023 by the European Commission, the Heads of Medicines Agencies (HMA) and the EMA, and contained more than 200 active substances. A substantially expanded second version followed in December 2024, based on an analysis of around 2,200 active substance groups and combinations — roughly 75% of all authorised medicines in the EU.
Being on the list is not a prediction. As the EMA is explicit about: inclusion doesn't mean a medicine is likely to experience a shortage soon — it means preventing a shortage for that medicine is particularly important, because unavailability could cause significant patient harm or strain on health systems.
How a medicine qualifies
Criticality is assigned using two combined criteria:
- Seriousness of the disease treated. The more severe the condition, the stronger the case for inclusion.
- Availability of alternative treatments. A medicine with several therapeutic alternatives is a lower priority than one with none.
A further threshold applies: a medicine generally needs to be considered critical in more than a third of EU/EEA countries to make the list. The methodology was developed jointly with all EU Member States and with input from patient, healthcare professional, and industry stakeholder groups — it isn't a single national list scaled up.
How the list has evolved
| Version | What changed |
|---|---|
| 2023 — first version | Published following a review of around 600 active substance groups drawn from six national critical-medicines lists; over 200 substances included. |
| 2024 — second version | Substantially expanded, covering roughly 75% of authorised EU medicines, incorporating existing crisis-preparedness lists and EMA stakeholder input. |
| 2025 — annual update | 61 active substance groups assessed; 9 added to the list. |
| 2026 — editorial update | Terminology describing routes of administration standardised for interoperability; no medicines added or removed. |
Why this list matters more than a reference document
Two things make the Union List operationally important rather than just informative:
- It's the scoping mechanism for CMA obligations. The resilience, procurement, and reporting requirements the CMA introduces are, in practice, aimed at medicines on this list — not the full universe of authorised products.
- It drives MSSG vulnerability assessments. The EMA's Medicine Shortages Steering Group is actively assessing supply chain vulnerabilities across the list, starting with an initial tranche of medicines and expanding over time. The pace of that rollout is itself a signal worth tracking if you want to anticipate when your own products will come under scrutiny.
What to actually do with this
Cross-reference your full product portfolio against the current Union List and flag every match. That single exercise reframes your prioritisation for everything downstream: which products need a Shortage Prevention Plan first, where dependency mapping matters most urgently, and which products are most likely to face MSSG scrutiny before the CMA is even formally adopted.
Frequently asked questions
How often is the Union List of Critical Medicines updated?
It's reviewed annually. The first version was published in December 2023, a second, substantially expanded version followed in December 2024, and an annual update in 2025 assessed 61 active substance groups and added 9 to the list.
Does being on the list mean a shortage is likely?
No. Inclusion signals that continuity of supply is a priority and that a shortage would cause significant harm, not that a shortage is imminent or expected for that specific product.