Brendan Griffin (Kerry, Fine Gael)
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519. To ask the Minister for Health his assistance and clarification with a matter (details supplied); and if he will make a statement on the matter. [44766/23]

Michael Healy-Rae (Kerry, Independent)
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552. To ask the Minister for Health If he will address a matter (details supplied); and if he will make a statement on the matter. [44970/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 519, 534 and 552 together.

Amdipharm Limited (also known as Advanz Pharma), the company responsible for supplying levothyroxine oral solution, has advised that new stock of levothyroxine oral solution was expected to arrive in Ireland on 13^thOctober 2023. The company has also advised that it expects a further delivery of additional stock on 6^thNovember 2023.

The Health Products Regulatory Authority (HPRA) has also advised my Department that the wholesaler involved in providing the medicine is arranging for expedited delivery of the medicine to the patient’s pharmacy.

Amdipharm Limited has provided the contact details below which can be used by pharmacies in the event that they are unable to obtain the product from wholesalers.

• 01 5294230 (Irish customer care)
• Email : customercareireland@advanzpharma.com

Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations includes an exemption which enables practitioners to prescribe a medicine as an exempt medicinal product (EMP) under that practitioners direct responsibility, in order to fulfil the special needs of that specific patient. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.

As EMPs have not been granted a marketing authorisation in Ireland by the HPRA, they would not be assessed by the HPRA for quality, safety or efficacy. If sourced in response to a bona fide unsolicited order as a licensed product from another market these medicines will have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in that country carried out by the respective competent authority for medicines in that state.

Medicine shortages are a feature of modern health systems worldwide and a global health problem, not unique to Ireland. Unfortunately, there are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues. Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the HPRA, to prevent, wherever possible, and to manage medicine shortages when they occur.

My Department maintains regular contact with the HPRA regarding medicines shortages.