Medicine supply security has become one of the most heavily regulated corners of EU pharmaceutical law — and one of the fastest-moving. Between Regulation (EU) 2022/123, the reformed general pharmaceutical legislation and the Critical Medicines Act, marketing authorisation holders now face overlapping notification, monitoring and resilience obligations that carry real operational and commercial consequences. This is a practical map of what applies today, what is coming, and where the compliance effort should go.
From two months’ notice to a continuous monitoring regime
For years, the entire EU shortages framework rested on a single sentence. Under Article 23a of Directive 2001/83/EC, an MAH must notify the competent authority of a temporary or permanent supply interruption “at least two months in advance.” Together with the wholesaler public-service obligations in Article 81, that was effectively the whole regime.
Regulation (EU) 2022/123, in force since 1 March 2022, changed the model entirely. It gave the EMA a permanent shortages mandate, created the Medicines Shortages Steering Group (MSSG) to coordinate the EU response to “major events” and public health emergencies, and mandated a central reporting system — the European Shortages Monitoring Platform (ESMP). The shift is from a one-off courtesy notification to continuous, structured monitoring.
The ESMP is live — and reporting is mandatory
The ESMP moved from initial launch in November 2024 to full minimum-viable-product functionality on 29 January 2025, with mandatory use from 2 February 2025. When a product is placed under monitoring, MAHs of centrally authorised products and national competent authorities must submit structured data on supply, demand and availability.
The practical trap is treating this as an IT formality. Reliable ESMP reporting depends on clean master data (consistent product and pack identifiers), named responsible persons, and internal processes that can generate supply-and-demand figures at short notice. Companies that build this capability in advance cope; those that improvise when a monitoring request lands do not.
The Union list of critical medicines: know whether you are on it
The first Union list of critical medicines was published on 12 December 2023 with more than 200 active substances; version 2 followed on 16 December 2024. It draws on an analysis of roughly 2,200 active-substance groups and combinations — about 75% of medicines authorised in the EU. Crucially, inclusion is based on the severity of the condition treated and the absence of alternatives, not on a product being at risk of shortage.
Being on the list matters because it concentrates regulatory attention and policy action. The European Commission has already run supply-chain vulnerability reviews for products on the list, publishing results for an initial set of 11 medicines on 10 July 2024. If your portfolio includes listed products, expect closer scrutiny — and prepare vulnerability assessments before you are asked for them.
The pharma package tightens notification dramatically
The reform of the general pharmaceutical legislation replaces the old two-month rule with a graduated, far more demanding regime. In broad terms, MAHs will need to notify:
- Permanent cessation or MA withdrawal — at least 12 months before the last supply;
- Temporary suspension of marketing — at least 6 months in advance;
- Any expected temporary supply disruption lasting more than two weeks — as soon as possible, and no less than 6 months before it starts.
The obligations go beyond timing. Notifications must carry a defined minimum data set (product details, available stock, expected duration and cause). MAHs will also be expected to maintain shortage prevention plans for certain products and to produce shortage mitigation plans when a disruption is foreseen. The practical implication is strategic: lifecycle decisions — discontinuations, transfers, site or supplier changes — now need planning horizons measured in quarters, not weeks.
The Critical Medicines Act: from monitoring to industrial policy
Everything above is about visibility. The Critical Medicines Act is about changing the economics of supply. The Commission proposed it on 11 March 2025; the Council agreed its general approach on 2 December 2025; and the Council and Parliament reached a provisional political agreement on 12 May 2026. The final text is expected in the Official Journal towards the end of 2026, with the date of application confirmed at that point.
Its centre of gravity is procurement reform. Public buyers of critical medicines will be required to move away from a “lowest price wins” default and to weight resilience criteria — security of stock, diversification of supply sources, and manufacturing located within the EU. The Act also makes collaborative and joint cross-border procurement easier and supports “strategic projects” to expand EU manufacturing of critical medicines and their active ingredients.
For suppliers, that is a double-edged change. Tenders will increasingly reward companies that can evidence a robust, diversified supply chain — and penalise those competing on price alone. The compliance question (“can we report?”) is becoming a commercial one (“can we win on resilience?”).
What this means in practice — including in Greece
A focused programme of work covers most of the exposure:
- Map your portfolio against the Union list and relevant national critical-medicines lists.
- Build an ESMP-ready data and process capability, with named owners and rehearsed reporting.
- Re-plan lifecycle and discontinuation decisions around the new 6- and 12-month notification horizons.
- Prepare shortage prevention plans, mitigation plans and supply-chain risk assessments proactively.
- Reframe tender strategy around demonstrable resilience, not price alone.
Smaller markets deserve particular attention. In Greece, products are more exposed to withdrawal and parallel-export pressure, and EOF notification duties and national availability rules sit on top of the EU layer. Aligning the two early avoids the scramble when a supply issue — or a resilience-weighted tender — arrives.
How PQRA helps
PQRA works with marketing authorisation holders to turn this fragmented rulebook into a single, workable plan: assessing portfolio exposure against the Union list, building ESMP reporting and notification processes that hold up under pressure, drafting prevention and mitigation plans, and aligning EOF and EU obligations for the Greek market. Because our regulatory, quality and market-access teams work together, supply security is handled as one connected business risk rather than a stack of separate filings.
To review how the evolving EU supply-security framework affects your portfolio in Greece and the EU, get in touch with the PQRA team.
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