The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.

MAHs must submit these plans to national competent authorities upon request and are required to implement them by mid-2027 under the new EU pharmaceutical legislation.

The agency explained that the goal of the SPPs is to identify vulnerabilities within medicine supply chains and ensure that appropriate measures are in place to prevent, mitigate, or manage any risks that could lead to shortages...[EMA - RAPS]