The European Medicines Agency has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.
The main objective of the SPPs is to ensure the MAH has appropriate systems and processes in place to identify potential risks in the supply chain that may impact the supply and availability of medicines, with clear risk minimisation measures to reduce the likelihood of shortages. It is recommended that MAHs high-level hierarchy maintain oversight of the development and update of the SPPs.