Reporting a medicine shortage
Pharmaceutical companies and wholesalers must ensure an appropriate and continuous supply of the medicines they market in Ireland. Companies should notify shortages or potential shortages of medicines to the HPRA and the HSE. The company or other legal entity that has the authorisation to market a medicine in Ireland is known as the marketing authorisation holder (MAH).
Patients and healthcare professionals can also assist by reporting possible shortages not currently included on the HPRA shortages list. Visit the Medicines shortages page or the Shortages of veterinary medicines page for more information.
All those in the medicines supply chain can play a role in preventing and effectively managing product shortages. This is a key goal of the multi-stakeholder medicines shortages framework. You can read more about this framework in the Medicine shortages framework document.
How to report?
Dedicated forms are available for each stakeholder group to report medicines shortages affecting the Irish market. Please download and return the relevant form by email.
Marketing Authorisation Holders
Download the notification of medicinal product shortage from marketing authorisation holder form. Please return completed forms to the Shortages section of the HPRA and the HSE's Corporate Pharmaceutical Unit. Contact details can be found on the notification form.
Wholesale Distributors and Manufacturers
Download the notification of medicinal product shortage from wholesale distributors and manufacturers form. Please return completed forms to the Shortages section of the HPRA.
Patients and Healthcare Professionals
Download the notification of medicinal product shortage from patients and healthcare professionals form. Please return completed forms to the Shortages section of the HPRA. When completing this form, please include as much information as possible.
Veterinary Medicines
Please visit the Department of Agriculture, Food and the Marine website for information on the Veterinary Medicine Shortages Protocol. The Department has published a number of notification forms for veterinary medicine shortages.