Navigating the Latest EU Legislative Changes on Shortage Monitoring and Security of Supply

Medicine supply disruptions place a strain on healthcare systems and patient care across the European Union, with consequences spanning from patient safety to disruption of internal markets. The root causes of shortages are multifactorial and may include manufacturing issues, supply chain disruptions, and vulnerabilities affecting the sourcing of key ingredients.

For patients, such shortages can lead to delays or interruptions in treatment, prolonged hospitalisation, increased reliance on alternative therapies, and a heightened risk of exposure to falsified medicinal products. Recent events, including the COVID-19 pandemic and the widespread shortages of antibiotics during the winter of 2022–2023, further exposed Europe’s structural dependencies within global pharmaceutical supply chains and underscored the need for coordinated legislative action at the Union level.

In response, the new EU pharmaceutical Regulation and Directive, expected to come into force in 2028, establishes a strengthened framework for medicines shortage monitoring and security of supply across the European Union, introducing new obligations for marketing authorisation holders (MAHs), suppliers, health authorities, and the European Medicines Agency (EMA). Combined with the creation of the Health Emergency Preparedness and Response Authority (HERA) on 16th September 2021 and the reform of the EU pharmaceutical legislation, the framework aims to enhance supply chain resilience and ensure the continuity of medicinal product availability under both routine conditions and crisis situations.

Accordingly, MAHs, suppliers, health authorities, and the EMA will be subject to clear legal obligations to ensure appropriate and continuous supply of medicinal products to patients within Member States, alongside timely and transparent communication on medicine supply issues.

What is a medicine shortage?

The new EU pharmaceutical regulation introduces a clearer and more structured definition of shortages. The framework now distinguishes between three key types, enabling regulators and MAHs to respond in a more targeted way.

• A “shortage” is defined as a situation in which the supply of a medicinal product fails to meet demand, irrespective of the underlying cause.
• A “critical shortage in a Member State” is a shortage that significantly impacts the healthcare system or poses a risk of harm to patients. It is where no suitable alternative medicine is available in sufficient quantities and cannot be resolved at the national level.
• A “critical shortage of Union concern” occurs when a critical shortage cannot be addressed by an individual Member State alone and requires coordinated action at the European Union level to ensure patient protection and supply continuity.

Obligations and responsibilities of MAH

Shortage prevention responsibilities extend beyond supply chain management and apply when a marketing authorisation holder (MAH) intends to withdraw, suspend, or disrupt the supply of a medicinal product. The new regulation requires MAHs to proactively notify the relevant competent authorities and, where applicable, the European Medicines Agency (EMA) of any anticipated permanent withdrawal of a marketing authorisation, permanent cessation, temporary suspension of marketing, or any supply disruption expected to exceed two weeks. Such notifications must be submitted electronically and as soon as the MAH becomes aware of the anticipated disruption. In principle, notifications should be made at least six months in advance of any interruption, unless justified exceptional circumstances apply, explicitly excluding financial considerations.

Where an MAH intends to permanently cease marketing a medicinal product or withdraw its marketing authorisation, the competent authority must be informed at least twelve months before the final supply is placed on the market, together with a clear justification for the decision. In cases of temporary suspension or non-permanent supply disruption exceeding two weeks, the MAH is required to notify the relevant Member State no later than six months prior to the start of the interruption. Derogations from these deadlines are permitted only where the MAH is demonstrably prevented from compliance due to unforeseen or exceptional events.

Critical shortages of Union concern and the European shortages monitoring platform

Shortages will be classified into 4 categories: a shortage, a critical shortage in a member state, a critical shortage in the EU or a critical shortage of a critical medicine (Figure 1). As monitoring these shortages is essential and to streamline processes for reporting and monitoring shortages, a new European Shortages Monitoring Platform (ESMP) has been developed and is now live on the European Medicines Agency (EMA) website. The ESMP enables the systematic reporting of information on medicine availability, stock levels, and shortages across the European Union.

The platform aggregates data submitted electronically by national competent authorities (NCAs) and marketing authorisation holders (MAHs). Under normal circumstances, all MAHs of centrally authorised medicinal products are required to use the ESMP to report potential or actual shortages on a regular basis. Once a MAH becomes aware of a risk to supply, the relevant information must be promptly entered and kept up to date on the platform. The new regulation will further require MAHs to notify the EMA according to a defined period in advance of an anticipated shortage, where feasible, prior to the interruption occurring.

In parallel, the Medicines Shortages Steering Group (MSSG) maintains a regularly updated list of critical shortages of Union concern. National competent authorities identify medicinal products they consider critical at the national level, which are then consolidated, adopted, and published by the European Commission. This process supports coordinated action at both national and Union level to ensure security of supply for these critical medicines. The ESMP is also used in the context of MSSG led preparedness activities, whereby the MSSG establishes lists of urgently needed medicinal products to address emerging or anticipated public health needs. These lists may include both centrally and nationally authorised products.

In addition, the ESMP serves a key role during public health emergencies or other major events. In such situations, MAHs and NCAs are required to report detailed information on the supply, demand, and availability of medicinal products to facilitate close monitoring and coordinated response measures. This enhanced reporting obligation applies to both centrally and nationally authorised medicines and is triggered when a crisis is formally recognised by the European Commission, reflecting the lessons learned from the COVID 19 pandemic. These activities are underpinned by the EMA’s extended mandate, as established in Regulation (EU) 2022/123, which reinforces the Agency’s role in monitoring and mitigating medicine shortages at the Union level.

Figure 1: European Commission (2023) Communication: “Addressing medicine shortages in the EU” COM(2023) 672 final (24 October 2023)

Shortage prevention plans

The EU’s approach to medicine shortages operates across three escalating levels: prevention, mitigation, and last resort intervention. Introduced through EMA guidance and reinforced under the EU Pharma Package, they require marketing authorisation holders (MAHs) to take a proactive, risk based approach to anticipating and preventing supply disruptions before they occur. Essentially, Shortage Prevention Plans (SPPs) focus on preventing shortages, whilst Shortage Mitigation Plans (SMPs) define action once the shortage occurs.

At the earliest stage, SPPs require companies to proactively identify risks and prevent disruptions through forecasting, supply chain resilience, and early warning systems. These plans focus on avoiding shortages altogether by maintaining alignment between supply and demand and ensuring vulnerabilities are addressed before they materialise. The focus is on preventing shortages from occurring in the first place. While EMA guidance does not impose a single fixed-time horizon, it does expect companies to monitor current and projected demand trends, identify potential demand surges (e.g. seasonal peaks, epidemics, guideline changes), and align production and inventory planning with anticipated needs. This often translates into rolling forecasts of 3–6 months or longer for critical medicines, supported by historical utilisation data and market signals. SPPs require companies to assess and strengthen the resilience of their supply chains. This includes identifying single points of failure (e.g. a single manufacturing or batch-release site), diversifying suppliers and manufacturing locations where feasible, increasing safety stock or buffer inventory for critical products, and strengthening quality and production systems.

Where a shortage cannot be avoided, SMPs are activated. These define the operational response once a disruption occurs, including measures such as therapeutic substitution, prioritisation of patients, and coordinated communication with healthcare professionals. Their role is to minimise the impact of a shortage on patient care and define action once a shortage occurs, rather than prevent it.

When both prevention and mitigation are insufficient, systems escalate to last resort measures, where authorities and healthcare providers intervene directly. This may involve preparing extemporaneous medicines, authorising unlicensed products, adapting clinical practice, or restricting access to limited supply. These measures represent a shift away from normal regulatory and market mechanisms towards direct public health intervention.

Adapting prescribing practices when medicines are unavailable

Under the EU Pharma Package, prescribing practices during shortages are not left to informal or ad hoc decision-making but planned into SPPs and SMPs. These plans require companies and regulators to anticipate how patient care will be maintained during supply disruptions. The most immediate response when a medicine becomes unavailable is therapeutic substitution. This means switching patients to alternative treatment options, which may include the same active substance in a different formulation or strength, medicines within the same therapeutic class, or, where necessary, clinically appropriate alternatives from a different class.

The EU framework recognises that such switching is often unavoidable and may introduce clinical complexities, which is why SPPs require an upfront assessment of available alternatives. This ensures that substitution strategies are anticipated in advance, rather than improvised under pressure during a shortage.

In more severe scenarios, prescribing practices are further adapted through prioritisation and demand management measures. This may involve reserving limited supplies for patients with the greatest clinical need, delaying initiation of treatment for less critical conditions, or adjusting prescribing practices to reduce unnecessary use. These measures are particularly important for medicines included on the Union list of critical medicines, where continuity of supply is prioritised due to the potential for serious harm in the event of disruption. Additionally, demand may be actively managed through approaches such as prescribing the lowest effective dose or reviewing ongoing treatments to avoid waste.

Where no authorised alternatives are available, the EU framework allows the use of contingency options, including pharmacy-compounded (extemporaneous) preparations and unlicensed or imported medicines. These approaches, supported by regulatory flexibilities and the European Directorate for the Quality of Medicines & Healthcare (EDQM) quality standards, act as last-resort mechanisms to ensure continuity of care when standard supply chains fail. By formalising these elements, the framework reduces variability in clinical decision-making and supports a more harmonised response across the EU.

However, the framework also recognises that switching treatments carries inherent risks, including medication errors, potential adverse effects, and variability in treatment outcomes. As a result, adapted prescribing must be accompanied by enhanced clinical monitoring, clear communication with patients, and ongoing reassessment of treatment effectiveness, ensuring patient safety is maintained despite supply constraints.

Advertising controls during shortages

EU guidance makes a clear distinction between promotional activity and accurate supply information. Under the EU Pharma Package, SPPs and SMPs must include measures to minimise patient impact and manage demand, recognising that inappropriate demand generation can contribute to shortages. In practice, this can include limiting or pausing promotional campaigns.

As a baseline control, the advertising of medicines in the EU is primarily governed through existing legal restrictions, Directive 2001/83/EC, which continues to apply during shortages to ensure that promotional activity does not distort prescribing behaviour even outside shortage situations. Direct-to-consumer advertising is prohibited for prescription-only-medicinal products (POM) and psychotropics and narcotics. All promotional material must be objective, balanced, and not misleading. Restrictions are also placed on free samples and marketing incentives in the EU.

During shortages, EMA guidance demands that stakeholders must implement management strategies by avoiding activities that could stimulate demand in one population or region at the expense of others, or by marketing beyond actual product availability and supply. There is an obligation for MAHs to ensure fair and equitable distribution of medicines. Under the EU Pharma Package reforms, Member States may be empowered to temporarily suspend advertising of a medicinal product during a shortage or impose additional restrictions on promotions and free samples. This introduces as specific-shortage-triggers control, allowing authorities to directly limit marketing where it could worsen supply issues by concentrating demand on limited products.

The Pharma Package also strengthens general advertising rules by expanding the definition of advertising to include broader promotional activities, tightening controls on misleading claims and comparative advertising, particularly for biosimilars, requiring strong substantiation grounded in the Summary of Product Characteristics (SmPC) data and thorough medical and legal review. In a shortage context, these measures help reduce the risk that promotional activity could inadvertently concentrate demand on products where supply is already constrained or encourage unnecessary switching between treatments.

There is a strategic pivot toward scientific exchange and independent medical education, driven by the growing importance of access to neutral, objective information, requiring new models for engaging healthcare professionals. Cross-border digital marketing approaches to account for varying national interpretations of the expanded advertising scope are being reviewed and adjusted. Pharmacovigilance and supply chain monitoring is seeing greater investment to minimise the risk of shortages that could lead to disruption of advertising and wider commercial strategies.

Last-resort measures: (when authorities step in to prepare medicines)

When standard mitigation strategies are no longer sufficient, EU authorities can escalate to last-resort measures to safeguard patient care. These include the preparation of extemporaneous or unlicensed medicines by pharmacies, supported by initiatives such as the European Drug Shortages Formulary, as well as the use of imported or specially manufactured products outside normal authorisation pathways.

At the system level, Regulation (EU) 2022/123 enables coordinated EU action during crises, including redistribution of supply, stockpiling of critical medicines, and regulatory flexibilities to accelerate access to alternatives. In the most severe cases, authorities may also intervene in manufacturing and supply chains. Together, these measures represent a shift from market-based solutions to direct public health intervention to ensure continuity of treatment when all other options have been exhausted.

EU initiatives led by the EDQM recognise extemporaneous (compounded) preparations, and stock/unlicensed pharmacy preparations. The European Drug Shortages Formulary (EDSForm) is being developed to provide standardised methods for preparing these medicines. This is truly a last resort when no authorised or imported alternatives exist. In extreme shortages, authorities may accelerate regulatory procedures and apply temporary regulatory flexibilities. If shortages escalate to a multi-country or critical level, EU-level coordination is triggered.

The EMA’s Medicines Shortages Steering Group (MSSG) monitors critical shortages and can coordinate cross-border supply measurers alongside ESMP to enable redistribution of medicines between Member States. The Critical Medicines Act proposals also enable redistribution through shared European supply measures. In extreme or long-term shortages, authorities may intervene by supporting EU-level manufacturers and diversifying supply chains. These measures are considered a ‘last-resort’ because they incur greater risk, deviating from standard market and regulatory pathways and are only used when substitution, rationing, and demand controls have been exhausted.

A recent example of last resort measures in practice is the EU-wide shortage of amoxicillin during 2022–2024. As demand surged following a rise in respiratory infections, supply constraints led to widespread shortages across EU Member States. While early responses focused on substitution and regulatory flexibility, these proved insufficient, particularly for paediatric formulations where alternatives were limited. Authorities therefore escalated to last-resort measures, including the use of extemporaneous and unlicensed preparations. The EDQM supported this by issuing guidance on pharmacy prepared amoxicillin formulations, ensuring that patients could continue treatment despite the absence of licensed products.

Key takeaways

The new EU pharmaceutical legislative changes introduce enhanced obligations for marketing authorisation holders, and responsibilities for health authorities, aimed at improving the monitoring, prevention and management of medicine shortages within the European Union. From the implementation of shortage prevention plans to the management of critical shortages of Union concern, these measures collectively represent a more proactive and coordinated approach to safeguarding the supply of medicines to patients.

As the regulatory landscape continues to develop in the lead-up to the enactment of legislation in 2028, early engagement and strategic planning will be essential to ensure compliance and maintain uninterrupted patient access to medicines. Through DLRC’s EU Pharmaceutical Reform Insights Package, we can help you understand and prepare for the upcoming changes. Contact us today at hello@dlrcgroup.com to find out more about the EU Pharmaceutical reform.