Blog

The Critical Medicines Act, in plain language

Explainers on obligations, deadlines and documentation for regulatory affairs and QA teams — written while the legislation itself is still in motion.

Overview · 12 min

Critical Medicines Act explained: what changes for marketing authorisation holders?

The core obligations, the timeline toward formal adoption, and what this means in practice for your regulatory affairs team.

Explainer · 8 min

What is a Shortage Prevention Plan (SPP)?

Its structure, the expected content, and how an SPP relates to documentation you already maintain.

Deadlines · 7 min

CMA notification deadlines explained: the 12- and 6-month rule

Exactly when you need to notify, who to notify, and what happens if you're late.

Step-by-step · 9 min

How to build a Shortage Mitigation Plan

From first signal to escalation: how to set up an SMP you can actually use during a real shortage.