The Medicinal Products Regulations 2007 (S.I. 538/2007, 539/2007, 540/2007) require the notification of receipt and importation of exempt (unauthorised) medicinal products by wholesalers and manufacturers, respectively, to the Irish Medicines Board (IMB). The IMB set up a Notification System to meet this requirement, and the system became operational on February 18th 2008.

Essentially the above-mentioned regulations require wholesalers and manufacturers to notify the IMB within 2 working days of receipt of exempt medicinal products.

For further details on the Notification System and the circumstances under which exempt medicinal products may be used, please refer to the following hyperlinks.


Guidance Note on the Notification System for Exempt Medicinal Products

Exempt products Excel spreadsheet.


Please address any queries relating to Guidance or spreadsheet to the following email address: compliance@imb.ie