The supply–regulatory bridge
Supply risk and regulatory duty in one view — notify on time.
Change #4 of 10 — Supply Chain / RA
You now have six months to tell regulators before you stop supplying.
Articles 116–119 require a Shortage Prevention Plan for every Rx product, six months' advance notice before discontinuation, and a 48-hour risk assessment when a shortage is reported. Most companies lack the supply visibility to meet these obligations.
Art. 116–119 — Supply
Now enforceableNotify regulators — before you stop
Planned withdrawal
6months
advance notice before stopping supply
was ~2 months, best-effort
Unplanned disruption
48hours
to report + file a mitigation plan
no fixed deadline
Miss the window and fines reach up to 5% of turnover.
Notification moves from a voluntary best-effort to a hard, enforceable obligation with fixed deadlines and a mandatory Shortage Prevention Plan behind it.
The scale of the obligation
Supply management is now a regulatory document
The SPP isn't an ops contingency plan — it's a dossier-linked regulatory submission EMA will review.
6mo
Advance notice before discontinuation — measured from when the company knows supply will stop
SourceArt. 116, EU Pharmaceutical Directive 2026
48hr
Maximum time to complete risk assessment and notify the competent authority when a shortage is identified
SourceArt. 118, EU Pharmaceutical Directive 2026
86%
Of EU hospitals reported at least one critical medicine shortage in 2023
SourceEAHP Medicine Shortage Survey, 2023
What's actually changing
From best-effort notification to enforceable obligation
Under the current framework, shortage notification is inconsistent across Member States. The directive replaces that with hard, harmonised obligations.
Workbench
+ New TaskQuick Tasks/Shortage prevention — current vs new directive
Our CMO just told us they're stopping API supply in 90 days. We needed to notify regulators six months ago.
RegIntel12:39
132.00s182 sources93% confidence2 warnings
2 warnings
Here's the obligation delta for Shortage prevention. The new EU Pharmaceutical Directive replaces Directive 2001/83/EC[1][2] — below is what changes, row by row.
Current vs. new directive4 rows
Change area
Current — 2001/83/EC
New directive — from ~mid-2028
Shortage Prevention Plan
Current
No formal SPP in MA dossier. Internal contingency plans are operational — not regulatory submissions.
Discontinuation notice
Current
Voluntary notification with varying national requirements (typically 1–3 months).
New directive
Six-month advance written notification before any supply cessation. Clock starts when company becomes aware — not at formal withdrawal.[5]
Shortage reporting
Current
No harmonised EU timeline. Different definitions and windows per Member State.
New directive
48-hour mandatory risk assessment and notification via ESMP. Harmonised shortage definition across EU-27.[6]
⚠Dates reflect the political agreement text; final deadlines depend on entry into force and the transition period for each obligation.
Synthesised from 24 citations across 182 regulatory sources.
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Why existing approaches don't solve this
The missing layer
Supply chain data lives in ERP. Regulatory obligations live in your MA dossier. The directive requires these worlds to connect.
ER
ERP / supply chain systems
The supply data source
ES
ESMP / EMA shortage portal
The reporting endpoint
How Regunaut solves it
Five steps. Your supply obligations under control.
Each step maps a phase of shortage compliance — from drafting your first SPP to managing a live supply event.
Guided supply chain mapping node by node with vulnerability scoring, geographic concentration analysis, and dossier-ready SPP export.
- Guided supply chain mapping
- Single-source dependency auto-detection
- Minimum stock level editor by market
- Dossier-ready SPP export
Industry evidence
The shortage crisis gave regulators the mandate to act
COVID-19 exposed EU medicine supply vulnerabilities. There is no softening these requirements.
300+
Active medicine shortages in the EU at any given time in 2023–2024 — up from fewer than 50 in 2019
EMA ESMP data, 2024
€5M
Maximum fine per violation for shortage notification failures under Art. 168
Art. 168, EU Pharmaceutical Directive 2026
74%
Of shortages in 2023 involved products with a single EU manufacturing site
EFPIA Supply Chain Resilience Report, 2024
“The 48-hour notification requirement will expose the most companies. Most RA teams aren't operationally connected to supply chain systems in a way that enables assessment and notification within two working days.”
Common questions
What teams are asking about shortage prevention
Don't find out about shortage obligations when a supply event occurs
The 48-hour clock doesn't wait for you to find the right template.
Build your SPP now
Structured supply chain mapping, vulnerability assessment, and dossier-ready output.
Set up shortage preventionMap critical medicines exposure
30-minute session identifying portfolio products on the EMA critical medicines list.
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