The European Medicines Agency (EMA) has published guidance for industry on implementing Shortage Prevention Plans (SPPs), a key tool for ensuring continuous supply of medicines in the EU. The guidance, dated 17 July 2026, outlines the type and detail of information required in SPPs, which will become mandatory for prescription medicines under the new pharmaceutical legislation. It aims to help marketing authorisation holders (MAHs) comply with their obligation to ensure adequate and continuous supply, as set out in Article 56(3) of the new pharmaceutical Directive. The guidance also clarifies that the degree of effort and formalisation should be proportionate to the identified risk level for each medicine, and it includes a minimum set of information that SPPs must contain, as specified in Part V of Annex IV of the new Regulation.
The guidance builds on a decade of EU efforts to improve medicine availability. Since 2016, the European Medicines Regulatory Network (EMRN), comprising EMA and national competent authorities, has been monitoring and managing medicine availability issues, including supply chain disruptions. These systems were reinforced by Regulation (EU) 2022/123, which formally established the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and the Medicines Shortages Single Point of Contact Working Party (SPOC WP). Under that regulation, EMA may request SPPs for critical medicines during a public health emergency or major event, requiring information on production and supply capacity, approved production sites, potential alternative sites, and minimum stock levels.
The new pharmaceutical Regulation, which is set to replace the current framework, extends this obligation: Article 117(1) requires MAHs to establish and maintain up-to-date SPPs for all prescription medicines, and for any other products identified by the European Commission. The guidance notes that the Commission may extend the scope at its discretion. This legal obligation is complemented by a recommendation in the good practices for industry for the prevention of human medicinal product shortages, which lists SPPs as one of its key recommendations.
The guidance is intended to support MAHs in preparing SPPs that are both effective and proportionate. For low-risk medicines, a simpler plan may suffice, while higher-risk products will require more detailed planning, including specific shortage mitigation measures. The document also includes an annex with the minimum information set, ensuring consistency across the EU. By providing a clear framework, EMA aims to reduce the administrative burden on industry while ensuring that supply chains remain resilient, particularly for critical medicines.
Stakeholders will be affected differently. MAHs, particularly those with large portfolios of prescription medicines, will face new compliance costs as they develop and maintain SPPs, though the risk-based approach may limit the burden for lower-risk products. National competent authorities will need to oversee compliance and may see an increased workload in reviewing plans. Patients and healthcare providers stand to benefit from fewer and shorter shortages, improving access to essential treatments. The guidance also has implications for generic and biosimilar manufacturers, who may need to align their supply chain planning with the new requirements. Overall, the guidance represents a significant step toward stronger supply chain resilience in the EU, balancing regulatory oversight with industry flexibility.