Medicines shortages
In European law, pharmaceutical companies and wholesalers must make sure that they have an appropriate and continuous supply of the medicines that they market. Companies should notify us of shortages or potential shortages of medicines that impact the Irish market.
We recognise that shortages of medicines can be challenging for those relying on medicines for their health and well-being. Many medicines supplied in Ireland have more than one strength, form, pack size or brand available from different suppliers. If the medicine you have been taking is not available, your doctor or pharmacist will often be able to supply an alternative strength, form, or product. This will help make sure that your treatment is continued.
We publish and maintain an up-to-date list of medicines shortages that impact the Irish market. This is to help keep patients and healthcare professionals informed of current shortages. We update this regularly with shortages* that have been notified to us and which may have an impact on patients in Ireland. Visit the Shortages pages for human medicines and veterinary medicines for more information.
View the list of current shortages for veterinary medicines.
View*Where a product is not listed as a shortage on the HPRA website, availability may differ across wholesale supply. As a result, pharmacists may need to check with other distributors.
We provide additional updates on specific medicines currently in short supply. Visit our Product specific updates- Shortages page for more information.
What is a medicines shortage?
The definition of a shortage is when the supply of a medicine does not meet the needs of the patient.
The World Health Organisation recognises medicine shortages are a global problem. They represent an increased focus for governments given their potential public health impact.
Why do medicines shortages occur?
A medicine shortage can occur for many reasons. Each shortage represents an individual set of circumstances. From information received from industry, we know that:
- Over 60% of shortages relate to delays or breakdowns during manufacturing or a product quality issue.
- Manufacturing can be delayed when an active substance or other ingredient is in short supply. Shortages in packaging materials can also lead to delays.
- Unexpected demand can cause shortages. For example, an unanticipated increase in the prescribing of a particular medicine. Greater than anticipated levels of seasonal illness can also result in shortages of medicines needed to treat those illnesses.
How are shortages of medicines handled in Ireland?
We co-ordinate and oversee the operation of a medicines shortages framework. Under the framework, we regularly update and publish a list of shortages on our website. This multi-stakeholder framework is intended to address shortages of human medicines in Ireland. You can read more about this framework further below on this page.
Can the HPRA take regulatory actions to reduce the impact of a shortage?
Yes, where regulatory flexibility can ease a supply issue without impacting patient safety, we will be as practical as possible. In particular, we focus on actions to address acute and urgent patient needs.
For example, we can provide accelerated regulatory approval to supply a medicine to Ireland initially intended for another market. This may involve allowing flexibility on labelling or packaging to support the supply of interim stocks. We can also accelerate the approval of controlled drug licences in a shortage.
What is outside the remit of the HPRA?
We cannot compel companies to supply or manufacture medicines.
We have no role in:
- The purchasing of medicines.
- Commercial issues.
- The provision of clinical advice and treatment to patients.
How do I report a medicine shortage?
Marketing authorisation holders should notify us of shortages or potential shortages of medicines. They should also notify the HSE.
Wholesalers, patients, and healthcare professionals can assist by reporting shortages that are not on our list of shortages.
You can find more information on our reporting a medicine shortage page.
What can pharmaceutical companies do to minimise shortages?
In European law, pharmaceutical companies and wholesalers must make sure that they have an appropriate and continuous supply of the medicines that they market.
Companies can help prevent shortages of medicines by continuing to reduce risk within their operations. When a potential shortage is identified, we should be notified as soon as possible. If the shortage cannot be prevented, we will work with other framework stakeholders to reduce the potential impact on patients, where possible.
Who manages shortages of veterinary medicines?
The medicines shortages framework
As noted above, we co-ordinate and oversee the operation of a medicines shortages framework. Under the framework, we regularly update and publish a list of shortages on our website. This multi-stakeholder framework is intended to address shortages of human medicines in Ireland. You can read about this framework in the document below.
The aim is to:
- Help avoid potential shortages from occurring in the first place.
- Reduce the impact on patients when shortages do occur.
The framework outlines procedures for notifying shortages, their evaluation, and communication. It also looks to further develop strategies that can help prevent shortages.
The framework sets out the roles of different stakeholders in managing shortages. Representatives of the following stakeholders participate in the framework:;
- Marketing authorisation holders (companies that have an authorisation to market a medicine in Ireland)
- Manufacturers
- Wholesale distributors
- Healthcare professionals
- The HSE
- Patient representative groups
The framework does not cover commercial activities such as:
- Pricing of medicines.
- Sourcing of medicines from suppliers.
- Clinical management of patients in the event of a shortage.
Two-year review of the shortages framework
We published a two-year review of the framework in November 2022. We reviewed data we gathered under the framework during 2019 and 2020. We also outlined the next phase of the framework.
We continue to work closely with the Department of Health, and our partners across the health system to further improve and develop the framework.