Pharmacists should only purchase and supply ULMs (otherwise known as “unauthorised medicinal products”) when they fit within the definition of “exempt medicinal products”.

An exempt medicinal product may be sold or supplied “ response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his individual patients on his direct personal responsibility, in order to fulfil the special needs of those patients…”.

This means that a medicinal product can only be defined as “exempt” when it is supplied to the order of a registered doctor or registered dentist for use by his individual patients under his direct personal responsibility. It is essential that you and all healthcare professionals in the supply chain are aware that exempt medicinal products have not been assessed by the Health Products Regulatory Authority (HPRA) against the criteria of safety, quality and efficacy, and that the responsibility for the clinical use of such products lies with the prescriber. For more information, please contact ourselves or the Health Products Regulatory Authority.