EMA Guidance and Template: Implementing Shortage Prevention Plans (SPP)

Improving the availability of medicines authorised in the European Union is a key priority for the European Medicines Regulatory Network. Supply chain disruptions can affect the continuity of medicine supply, making it important for Marketing Authorisation Holders (MAHs) to identify potential risks and establish measures to reduce the likelihood of shortages.

The European Medicines Agency (EMA) has published guidance and a template for industry on implementing Shortage Prevention Plans (SPPs). The guidance describes the information to be included in an SPP, the assessment of patient impact and supply chain risks, the final risk classification, and the shortage management measures to be considered.

Why Shortage Prevention Plans Are Important

All MAHs should establish and maintain an up-to-date SPP for medicinal products for human use that have prescription-only status in one or more EU/EEA countries. SPPs may be grouped for medicines that share a common supply chain, provided that the minimum required information can be made available within 2 days upon request.

The main objective of an SPP is to ensure that MAHs have appropriate systems and processes to identify potential supply chain risks that may affect the supply and availability of medicines, together with clear risk-minimisation measures.

The level of detail, formalisation, and documentation should be proportionate to the level of risk identified for the medicine. The SPP may also form part of the annual product quality review and should be updated when relevant changes occur, such as supply chain changes, a critical shortage, or MSSG recommendations.

Product Details and Supply Information

An SPP should provide clear information about the medicinal product and its supply arrangements.

The information includes the product name, active substance and manufacturers, finished product manufacturers, key inputs and suppliers, ATC code, therapeutic indication, pharmaceutical form, strength, route of administration, pack sizes, marketing authorisation details, Member States where the product is marketed, MAH information, and contact details.

Key inputs and suppliers may also be requested by competent authorities alongside the SPP minimum data set.

Patient Impact and Supply Chain Risk Assessment

The SPP uses a risk-based approach that considers both the potential patient impact of a supply disruption and the risks within the supply chain.

Patient impact considers the therapeutic indication and alternative marketed medicinal products, together with the estimated market share during the previous 12 months.

For therapeutic indication and alternative medicines, patient impact is classified as high, medium, or low depending on whether the medicine is included on the Union list of critical medicines, the Union long list or another EU/EEA critical medicines list, or neither.

Market share is also classified as high, medium, or low. High impact applies where EU-level market share is above 50%, while medium impact applies to an EU-level market share of 25–50% or more than 50% of an individual EU market. Low impact applies where EU-level market share is below 25%.

Supply Chain Mapping and Vulnerabilities

The supply chain assessment should provide a visual supply chain map covering the manufacturing sites involved at different stages of the manufacturing process.

The assessment should identify the location of manufacturing sites, the share of production volume associated with each site, and supply chain vulnerabilities and dependencies.

The guidance also asks MAHs to record resolved shortages lasting longer than one month that were notified at national level or to EMA during the previous three calendar years. The root causes of these shortages and the mitigation measures taken should be included.

For medicines on a critical list during a public health emergency or major event, additional information may include production capacity, supply capacity, potential alternative production sites for finished medicinal products and active substances, and minimum stock levels.

Supply Chain Risk Classification

The guidance classifies supply chain risk as high, medium, or low based on the information provided in the assessment.

A high supply chain risk may apply where there are a limited number of manufacturing sites, concentration of sites in a single geographical location, a high share of production volume at a particular site, or identified supply chain vulnerabilities and dependencies, together with more than five shortage notifications lasting longer than one month during the previous three years.

A medium risk classification may apply where the supply chain is more diversified, vulnerabilities are limited, or certain supply chain risk factors remain, together with up to five relevant shortage notifications during the previous three years.

A low classification applies where no supply chain risk is identified, and no shortage has been notified during the previous three years.

Final Risk Classification

The final risk classification combines the patient impact and supply chain risk assessments.

A high patient impact combined with a high or medium supply chain risk, or a medium patient impact with a high supply chain risk, results in a high final classification.

Combinations involving high and low, or low and high classifications result in a medium classification. Medium/medium, medium/low, and low/medium combinations also result in a medium classification. A low patient impact combined with a low supply chain risk results in a low final classification.

Shortage Management Measures

The level of detail in the SPP and the proposed shortage management measures should be proportionate to the identified risk.

For medicines with medium or high risk, the SPP should describe the risk control strategy used to minimise the likelihood of shortages and explain how the strategy is implemented. This may include information on safety stocks, other active manufacturing sites, distribution restriction measures, and other measures used to reduce shortage risks.

The SPP should also include processes for detecting and notifying supply disruptions, checking the effectiveness of the plan, reviewing and updating the SPP, and establishing the demand forecast.

The demand forecast methodology should explain how demand is calculated and monitored and what actions are taken when demand increases or decreases. As medicine availability and supply chain resilience remain important priorities in the EU, the EMA Shortage Prevention Plan framework provides a structured, risk-based approach for MAHs. The SPP brings together product information, patient impact, supply chain risks, previous shortage experience, final risk classification, and shortage management measures to support the prevention and management of potential medicine supply disruptions.

References

European Medicines Agency (EMA): Guidance and template for industry on implementing Shortage Prevention Plans (SPP), 17 July 2026.