In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies should notify the HPRA of medicines shortages or potential shortages impacting the Irish market. The HPRA maintains a list of current shortages on its website and is in regular contact with suppliers in relation to these shortages, with a view to minimising their duration and impact on patients. The webpage of the HPRA is updated daily as the HPRA receives new information related to ongoing and newly notified shortages. Shortages when published remain active until supply returns to an acceptable level to meet demand, irrespective of whether there is a suitable alternative supply available that is meeting that demand.
Addressing medicines shortages is complex and requires input from multiple stakeholders. A Medicines Shortage Framework (MSF) has been in place since 2018 when the Department requested that the HPRA assume responsibility for its coordination. Since its inception, the framework has been of enormous benefit nationally. It has served to avoid the occurrence of potential medicine shortages and, where they have occurred, ensured appropriate mitigation is in place.
As of 18th February 2026, there were 415 notified shortages published on the HPRA website. It is acknowledged that medicine shortages, when they occur, can be a challenge for patients and healthcare professionals. Each medicine shortage does not represent a defined risk to patients, and not all medicines shortages have the same potential impact on patients. In the case of medicines that are used most often in Ireland, there are typically multiple forms, strengths, brands, and generic medicines available from various sources.
Where some individual medicines are in short supply, alternative options such as alternative strengths, brands, and generic medicines remain available to ensure continuity of treatment. When a notification of a shortage is submitted to the HPRA an impact assessment is carried out and combines two main considerations - the availability of therapeutic alternatives and the expected impact on patient. In some cases where the medicine initially prescribed for the patient is unavailable, patients may be switched to a suitable therapeutic alternative following appropriate consultation with a healthcare professional. Regardless of patients being treated with suitable alternatives – a different brand for example – the shortage of each individual medicine will remain listed until supply returns to an acceptable level. The notification form also provides for a proposal from the MAH to handle a shortage, which may range from minimal activity in the case of low impact shortages, to a detailed management plan for high impact shortages.
For the notified shortages currently published (as of 18th February 2026) the impact assessment recorded was either a potential low impact or medium impact for ~80% of the cases. This means that in the majority of cases the required interventions to support continuity of care can be straightforward to administer in the clinical setting, such as that outlined already e.g. switching brands, or taking two tablets to administer the prescribed dose instead of one tablet (when using a different strength is an available mitigation measure).
Based on an analysis of data reported by companies to the HPRA related to shortages reported from January to May 2025, it takes an average (median) of 30 days for normal supply to resume from the date of market impact (unavailability). It is acknowledged that there is variance in the data, and individual supply interruptions can extend over a prolonged period on occasion.
Several initiatives have been taken over recent years at a European level to improve security of supply and address supply chain vulnerabilities that are common to multiple markets. These include an expansion of the mandate of the European Medicines Agency (EMA) to optimise the management and prevention of shortages at European level. In the proposed revision of the EU Pharmaceutical legislation the European Commission has proposed further strengthening measures and specific initiatives, such as the introduction of the Union list of critical medicines and the requirement for medicine suppliers to have in place shortage prevention plans (‘SPP’). Such measures are anticipated to further improve supply chain resilience and promote continuity of supply. The HPRA is committed to continuing its active involvement at European level to maximise the effectiveness of this work. There is also ongoing work nationally, with the introduction of new legislation, that will strengthen the capacity of the Medicines Shortage Framework (MSF) to prevent and mitigate shortages. This includes the introduction of mandatory notifications of shortages to the HPRA as well as facilitating the introduction of national stock monitoring systems. Such advancements should afford greater response capacity, with more forewarning of pending issues in supply, with actions that can then be taken in a timelier manner.
The companies who supply medicines and wholesale distributors, in particular, are key stakeholders in the supply chain that have more visibility of stock levels than others. These stakeholders must report potential shortages at an early stage. If action is taken at an early stage to avoid the shortage or any impact on patients and healthcare professionals, then no other action is required under the framework. Timely notifications are essential to have effective mitigation measures put in place with the view to avoiding any clinical impact and/or support continuity of care for patients reliant on these medicines. The HPRA routinely highlights to industry the importance of early notification.
