Templates for Shortage Prevention and Mitigation Plans issued by EMA

On 18th of June 2024, the EMA has issued templates for Shortage Prevention Plans (SPPs) and Shortage Mitigation Plans (SMPs). Marketing authorization holders (MAHs) in the European Union/European Economic Area are encouraged to create Shortage Prevention Plans to minimize the risk of medicinal shortages.

The availability of medicinal products is a central point in the strategy of the European Medicines Agency Network until 2025 and the European Commission's pharmaceutical strategy, which led to the revision of the pharmaceutical legislation in April 2023. The draft regulation obliges MAHs to establish Shortage Prevention Plans and Shortage Mitigation Plans.

In times of crisis, in form of a public health emergency or a major event, SPPs are already obligatory under Regulation 2022/123, for drugs listed in the list of critical medicines for that particular crisis.

The extent of the documents should correspond to the risk level of the medicine. For this reason, the ICH Q9 guideline on quality risk management is to be applied.

Companies are recommended to involve their highest level of management in the development of SMPs/SPPs. The plans should be created in English and, if necessary, translated into the local language upon request of the national competent authorities. As part of the pharmaceutical quality system, SPPs should be regularly updated and evaluated.

Shortage Prevention Plans help to identify and manage potential risks in the supply chain and include information on the MAH, the supply and manufacturing chain, key data on stock, sales, consumption and manufacturing and an analysis of the history of supply issues. A SPP should be in place for each medicinal product marketed by the MAH. The minimum requirements for the SPP state that MAHs should analyze and evaluate weaknesses in the supply chain. The robustness of shortage prevention measures is to be evaluated. MAHS are obliged to assess the risks of supply interruptions for patients. A medicine shortage risk register should be developed to identify clinically significant products based on therapeutic use and availability of substitutes. Using available information such as root cause analysis of shortages, the MAH is required to determine whether corrective and preventive actions or revalidation are needed, both nationally and internationally. Furthermore, MAHs should ensure that minimum stock levels are maintained at national levels. Measures to prevent drug shortages should be reviewed regularly.

Shortage Mitigation Plans are designed to eliminate potential or actual drug shortages and minimize the impact on patients.
The minimum requirements for the SMPs include procedures for dealing with shortages, from identification to resolution. These procedures should include measures to reduce the shortage's impact, notification to regulatory authorities, and follow-up actions. MAHs should define roles, responsibilities, escalation processes and maintain records of root causes and mitigation measures after resolving shortages.

SPPs and SMPs should be submitted to the competent authorities upon request.