Two EU legislative files get mentioned in almost every conversation about medicine shortages: the Critical Medicines Act (CMA) and the Pharma Package. They're related, they're often discussed together, and it's genuinely easy to lose track of which one requires what. This article draws the line between them.
Two different legislative tracks
The Pharma Package is the umbrella reform of the EU's general pharmaceutical legislation — the directive and regulation that have governed marketing authorisations, pharmacovigilance and shortage management for years. It was proposed alongside the CMA but runs on its own legislative track, and its provisions on shortage notification and management are, in practice, further along than the CMA's.
The CMA, by contrast, was proposed in March 2025 specifically to address supply chain resilience for a defined subset of medicines: those on the EMA's Union List of Critical Medicines. It reached a provisional political agreement between the Council and Parliament on 12 May 2026, but — as covered in our CMA overview — it still needs formal adoption before it enters into force.
Where they overlap
- Shortage notification. Both files touch on when and how a MAH must notify a discontinuation or interruption. The Pharma Package sets the general notification framework; the CMA adds reporting specifically through the ESMP for critical medicines.
- Shared goal. Both aim to reduce the frequency and impact of medicine shortages across the EU, and both were developed as part of the European Health Union agenda.
- Shared regulatory infrastructure. Both lean on EMA mechanisms — the MSSG (Medicine Shortages Steering Group) and the ESMP — rather than creating entirely separate reporting channels.
Where they differ
| Pharma Package | Critical Medicines Act |
|---|---|
| Applies broadly, to marketing authorisations generally | Applies specifically to medicines on the Union List of Critical Medicines |
| Sets the general 12-/6-month notification framework | Adds resilience, procurement and reporting obligations on top |
| Primarily a regulatory/pharmacovigilance reform | Primarily an industrial-policy and supply chain resilience instrument |
| Further along its own legislative track | Provisional agreement reached 12 May 2026, formal adoption pending |
What this means for your compliance work
In practice, don't wait to see which file lands first. The notification deadlines described in our meldtermijnen explainer already apply in substance under the Pharma Package track, and the CMA's obligations — vulnerability assessment, resilience-based procurement, ESMP reporting for critical medicines — build directly on top of the same product register and supplier data you need for Pharma Package compliance anyway. Building that foundation once, structured for both, avoids duplicating the work when the CMA is formally adopted.
Frequently asked questions
Do I need to comply with the Pharma Package before the CMA is adopted?
The Pharma Package follows its own legislative timeline, separate from the CMA, and its shortage-notification provisions are further along. In practice, most MAHs already need to track notification deadlines regardless of where the CMA stands.
Which one introduces the Union List of Critical Medicines?
The Union List of Critical Medicines is an EMA/MSSG instrument that predates and sits alongside both files. The CMA builds obligations on top of that list rather than creating it.
Want to see how this plays out for a specific product? Read how to map single-source dependency or revisit the full CMA overview.