Primary source: European Medicines Agency (EMA)
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.
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.
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.
Regulatory Intelligence Lead
Review before 2026-08-07.
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.
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.
Increase in documentation and planning requirements for MAHs.
Mandatory requirement for SPPs for prescription medicines.
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.
Published from the Firecrawl policy change extraction pipeline.
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