Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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739. To ask the Minister for Health if his attention has been drawn to a shortage of a drug (details supplied) used to treat epilepsy; the reason that pharmacies cannot guarantee more than one month’s supply of this medication; his views on whether there is a solution to guarantee a supply for a patient on a monthly basis; and if he will make a statement on the matter. [27902/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I have contacted the HPRA in relation to the query raised by the Deputy. They advised that the medication, Petinimid, is not an authorised medicine for the Irish market, but as it is authorised in other markets, it can be supplied in Ireland in response to a prescriber's request to meet the needs of patients in their care. This is known as exempt medicinal product (EMP) supply. It should be noted that the HPRA has no role in assessing the quality, safety, or efficacy of EMPs. These medicines will have undergone an evaluation of their safety, quality and efficacy for the granting of their marketing authorisation in another EU Member State or third county by the respective competent authority for medicines. 

The availability of EMPs can depend on the products' availability in the source market. As a result, supply can be variable, and the HPRA does not have the same oversight over the supply of these types of medicines compared to medicines authorised for the Irish market.

However, the HPRA has identified the wholesalers that had supplied Petinimid to the Irish market and engaged with them when they received the initial query from the patient's carer. Information received from one main EMP wholesaler has indicated that there is a product delivery estimated to arrive on 8th June 2022 and will be available to pharmacies to dispense thereafter.