EMA Guidance: Implementing Shortage Prevention Plans (SPP) for Medicines

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

The European Medicines Agency (EMA) has published the Guidance for industry on implementing Shortage Prevention Plans (SPP), providing a risk-based approach for establishing and maintaining SPPs for prescription medicines in the EU. The guidance describes the information to be included in an SPP, the assessment of patient and supply chain risks, and the shortage management measures that should be considered.

Why Shortage Prevention Plans Are Important

The guidance requires MAHs to establish and maintain an up-to-date SPP for medicinal products subject to prescription-only status in one or more EU/EEA countries. The scope may also be extended to other medicines at the discretion of the European Commission.

The main objective of an SPP is to ensure that MAHs have appropriate systems and processes to identify potential supply chain risks that could affect medicine availability and to establish clear risk-minimisation measures.

The level of detail, formalisation, and documentation should be proportionate to the level of risk identified for the medicine.

Product Details and Supply Information

An SPP should provide a clear overview of the medicinal product and its supply chain.

The information includes the product name, active substance and its 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.

For products with a common supply chain, MAHs may group or aggregate SPPs, provided that the required minimum information can be made available when requested.

Patient Impact and Supply Chain Risk Assessment

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

Patient impact is assessed using factors such as the therapeutic indication, availability of alternative marketed medicinal products, and the estimated market share in the previous 12 months.

The guidance classifies patient impact as high, medium, or low based on these factors. A medicine with a high market share or inclusion on relevant critical medicine lists may have a higher potential impact if supply is disrupted.

Supply Chain Mapping and Vulnerabilities

A detailed supply chain assessment should identify the manufacturing sites involved at different stages of production, their locations, the share of production volume associated with each site, and identified supply chain vulnerabilities and dependencies.

The assessment should also consider the history of resolved shortages lasting longer than one month during the previous three calendar years, including their root causes and the mitigation measures taken.

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

Risk Classification

The guidance combines patient impact and supply chain risk assessments to establish an overall risk classification.

Supply chain risk may be considered high where there are factors such as a limited number of manufacturing sites, concentration of sites in a single geographical location, a high share of production volume at a particular site, identified vulnerabilities or dependencies, and a history of multiple shortage notifications.

A medium risk classification may apply where the supply chain is more diversified but some vulnerabilities remain. A low classification applies where no supply chain risk has been identified, and no shortage has been notified during the previous three years.

The final classification combines the patient impact and supply chain risk assessments as high, medium, or low.

Shortage Management Measures

For medicines identified with relevant supply risks, the SPP should describe the risk control strategy in place to minimise the likelihood of shortages and explain how those measures are implemented.

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

For medium- and high-risk medicines, the guidance also calls for information on the methodology used to establish the demand forecast. This should describe how demand is calculated and monitored and what actions are taken when demand increases or decreases.

As medicine supply resilience continues to be an important regulatory priority in the EU, a structured and risk-based Shortage Prevention Plan can help MAHs identify supply vulnerabilities, establish appropriate mitigation measures, and support adequate and continuous medicine supply. The EMA framework provides a consistent approach for documenting product information, patient impact, supply chain risks, risk classification, and shortage management measures.

References

• European Medicines Agency (EMA): Guidance for industry on implementing Shortage Prevention Plans (SPP)