Exempt medicinal products (EMP)

Medicines placed on the Irish market must be authorised by the HPRA or the European Medicines Agency. However, there is an exemption to this rule where an authorised medicine is not available.

Medicines not authorised in Ireland may be supplied where a registered doctor, registered dentist, registered nurse prescriber or registered mid-wife prescriber has prescribed the product for a patient under their direct responsibility in order to fulfil the needs of those patients. In Ireland such products are called 'exempt medicinal products' (EMP).

Our role

Under the current medicines legislation, appropriately authorised wholesalers and manufacturers of medicines need to notify the HPRA about any exempt medicinal products they source to make available to Irish patients.

The Notification System for exempt products was set up to meet this requirement. The primary purpose of the HPRA receiving such information is to facilitate the recall of any defective exempt medicine from the Irish market.

Notifying receipt of exempt medicinal products

The manufacturer/wholesaler is required to complete and upload an Exempt Medicinal Products Excel Spreadsheet to the Notification System within two working days of their receipt of exempt medicinal products. You can login to this system on the Exempt Products Notification System login page.

The Guide to the Notification System for Exempt Medicinal Products provides further information on registering to the Notification System and the circumstances under which exempt medicinal products may be used.

You can send any queries relating to exempt medicinal products through our Contact Us page.