PV Bulletin

Mandatory Implementation of Shortage Prevention Plans (SPP) for Prescription Medicines in the EU

The European Medicines Agency (EMA) has issued guidance requiring Marketing Authorisation Holders (MAHs) to establish, maintain, and update Shortage Prevention Plans (SPPs) for all prescription medicines in the EU.

Primary source: European Medicines Agency (EMA)

PV Impact Brief

Urgency: HighConfidence: high

What changed

MAHs must now create and update Shortage Prevention Plans (SPPs) for all prescription medicines, integrating shortage monitoring into their signal management activities to ensure continuous availability.

Why it matters

This regulation aims to enhance the resilience of the supply chain, prevent medicine shortages, and protect patient safety by ensuring that potential supply risks are addressed proactively.

Action needed

Immediate compliance is necessary for MAHs to implement SPPs, including documenting production and supply capacities and establishing internal collaborative processes across supply chain, regulatory, and pharmacovigilance teams.

Relevant for
Regulatory Intelligence LeadSignal Management LeadQPPV
Processes impacted
Signal ManagementCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-08-07.

Policy change details

Document type
Guidance
Policy status
Final
Publication date
2026-08-07
Coming into force
2026-08-07
Effective date
2026-08-07
Policy change
This final guidance document provides Marketing Authorisation Holders (MAHs) with detailed instructions on how to create, maintain, and update Shortage Prevention Plans (SPPs) for all prescription medicines in the EU. It introduces a harmonized approach to proactive shortage management, requiring companies to identify potential vulnerabilities in their supply chains and implement preventive measures to ensure continuous availability of medicines.

Key changes

Introduction of a standardized SPP template and reporting framework; mandatory requirement for SPPs for all prescription medicines; establishment of internal company processes for cross-functional collaboration between supply chain, regulatory, and pharmacovigilance teams to monitor supply risks.

Affected workflows

Signal ManagementCountry Compliance

Responsible groups

MAHPV OperationsRegulatory Affairs

Document identifiers

EMA/65984/2024

PV impact

Pharmacovigilance departments must collaborate with supply chain and regulatory teams to identify safety-related supply risks that could lead to shortages. The guidance emphasizes the integration of shortage monitoring into signal management activities to detect and mitigate potential patient safety issues arising from medicine unavailability.

View regulator source

Source document details

Exact policy details

Legal basis for Shortage Prevention Plans (SPP)
Regulation (EU) 2022/123 mandates SPPs for prescription medicinal products.
Applies to: Marketing Authorisation Holders (MAHs) of medicinal products subject to prescription in the EU.
This information is found in section 1.2 Legal Basis. · p. 2 · High · Source
Minimum information to be included in SPPs
Production and supply capacity, approved production sites, alternative sites, minimum stock levels.
Applies to: Applicable to MAHs during a public health emergency or major event as per Regulation (EU) 2022/123.
Article 9(2) point c and Article 9(3) point k of Regulation (EU) 2022/123 mentions this requirement. · p. 2 · High · Source
Deadline for SPP submission during crises
SPPs must be submitted upon request during public health emergencies or major events.
Applies to: MAHs of medicines included in the list of critical medicines.
Refer to Article 10(2) of Regulation (EU) 2022/123. · p. 2 · High · Source

Workflow rule impacts

Country ComplianceMarketing Authorisation Holders (MAHs)

Increase in documentation and planning requirements for MAHs.

Mandatory requirement for SPPs for prescription medicines.

Introduction to SPPs outlines the legal obligations for MAHs. · p. 1 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Aug 7, 2026

Full briefing

Practical implication

Immediate compliance is necessary for MAHs to implement SPPs, including documenting production and supply capacities and establishing internal collaborative processes across supply chain, regulatory, and pharmacovigilance teams.

This guidance introduces a standardized approach to proactively manage medicine shortages by enforcing the creation of Shortage Prevention Plans. MAHs are now required to monitor their supply chains for vulnerabilities and collaborate across departments to address potential risks effectively.

What changed: MAHs must now create and update Shortage Prevention Plans (SPPs) for all prescription medicines, integrating shortage monitoring into their signal management activities to ensure continuous availability.

Why it matters: This regulation aims to enhance the resilience of the supply chain, prevent medicine shortages, and protect patient safety by ensuring that potential supply risks are addressed proactively.

Practical implication: Immediate compliance is necessary for MAHs to implement SPPs, including documenting production and supply capacities and establishing internal collaborative processes across supply chain, regulatory, and pharmacovigilance teams.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#European Medicines Agency (EMA)#final#Reporting Requirement#policy-change#Guidance#firecrawl-policy-agent

Related updates for your role

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Urgency: High

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Urgency: High

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Urgency: High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward