EMA issues updated guidance on shortage prevention plans ahead of legal deadline
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 stated that the updated SPP guidance and template complies with the legal requirements of Article 117 of the new pharmaceutical legislation. The updates also incorporate feedback from the EU Medicines Regulatory Network, including input from the Medicine Shortages Single Point of Contact (SPOC) Working Party and various industry associations. Article 117 of the new pharmaceutical regulation introduces the obligation to have a shortage prevention plan in place.
The guidance replaces a previous version issued in December 2024. (RELATED: EMA issues guidelines on shortage mitigation, prevention plans, Regulatory Focus 9 December 2024)
The guidance states that, “the new pharmaceutical Regulation includes provisions aiming to reinforce medicines shortage monitoring and management and strengthen supply chain resilience in the Union, including the obligation for Marketing Authorisation Holders (MAHs) to put in place, and keep up to date, a shortage prevention plan (SPP) for any medicinal product subject to prescription in the EU. The scope may be further extended at the discretion of the European Commission.”
This plan must include product information, shortage prevention measures, supply chain risk assessment, and the risk classification of the drug.
The guidance states that “these plans are only required to be submitted upon request to national competent authorities, the Agency or, in the context of crisis preparedness, the Commission, in accordance with the requirements set out in the text. When requested, the MAH will have two days to submit a copy of the SPP.”
It further specifies that the detail level for each SPP and the proposed shortage management measures should align with the identified risk level for each medicine.
The guidance includes an Annex 1, which specifies the minimum data set for the SPP template.
The guidance states that “SPPs may be aggregated/grouped for medicines that share a common supply chain, at the discretion of the MAH, as long as the minimum set of data, based on the template set out in Annex I, can be made available to National Competent Authorities, EMA or the European Commission within two days of a request to submit the plan.”
EMA also said it is currently working on a revision to its guidance and template for shortage mitigation plans (SMPs), which are expected to be adopted in Q4 2026.
