Blog
Explainers on obligations, deadlines and documentation for regulatory affairs and QA teams — written while the legislation itself is still in motion.
The core obligations, the timeline toward formal adoption, and what this means in practice for your regulatory affairs team.
Its structure, the expected content, and how an SPP relates to documentation you already maintain.
Exactly when you need to notify, who to notify, and what happens if you're late.
From first signal to escalation: how to set up an SMP you can actually use during a real shortage.
Where the two files overlap, where they differ, and which one actually governs your notification obligations today.
A practical approach to identifying which products depend on a single supplier or region — the foundation of vulnerability scoring.
What the European Shortages Monitoring Platform is, who reports through it, and how to avoid duplicate reporting.
A practical section-by-section template for a Shortage Prevention Plan — what to include and what auditors expect to see.
A practical checklist to assess whether your current SPP/SMP documentation would hold up under an audit.
How a medicine qualifies, how often the list is updated, and why it's the list your SPP/SMP obligations likely hinge on.