George Lawlor (Wexford, Labour)
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343. To ask the Minister for Finance the reason an over-the-counter medication (details supplied) purchased in another EU Member State was not allowed into the State by customs officials; and if he will make a statement on the matter. [16666/25]

Paschal Donohoe (Dublin Central, Fine Gael)
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I am aware that Revenue is committed to targeting the illegal importation of prohibited and restricted goods and implements a range of measures to identify and target illegal smuggling, and where possible, prosecuting those involved.

In the case of medicinal products, the Health Products Regulatory Authority is the competent authority in the state for dealing with these matters. If Revenue officers, during the course of carrying out their duties, discover medicinal products which they suspect may be illicit, the Revenue officers detain such goods and transfer them to the Health Products Regulatory Authority for any further action.

I have been advised that Melatonin is classed as a prescription only medicine in Ireland. The legislative basis of this is S.I. No 540 of 2003 – Medicinal Products (Prescription and Control of Supply) Regulations, 2003, where Melatonin is listed in column 1 of the First Schedule, which lists which substances when contained in medicinal products are subject to prescription control.

I have been further advised that in France, Melatonin can be classed as both a prescription only medicinal product or a food supplement depending on the dosage of the product:

• If the product contains 2mg or more of Melatonin, then it is classed as a prescription only medicinal product.
• If the product contains less then 2mg of Melatonin, then it is classed as a food supplement.

In general terms Revenue have informed me that medicinal products purchased online and imported into the state would be a breach of Regulation 19(1): Prohibition of mail order supply of medicinal products of S.I. No. 540 of 2003, which states ‘A person shall not supply by mail order any medicinal product’. Please note that mail order also refers to supply by the Internet.