Is Melatonin legal in Malta?

Situación formal

Melatonin in food supplements is governed purely at national level in the EU; no harmonised rule exists, and member states' approaches vary substantially.

Malta has set no national maximum: it applies EU food law and maintains no national "other substances" maximum-level list, so there is no Maltese figure for a 1 mg daily dose to sit inside or outside. No determination by the Malta Medicines Authority or the Superintendence of Public Health treating melatonin as a medicinal product could be located.

Maltese market practice fills that gap. Melatonin is openly sold in Malta as an over-the-counter food supplement at 1 mg, including through the Maltese storefront of a mainstream high-street health retailer, and at 5 mg elsewhere. No prescription is required for any of it.

¿Vendemos aquí?

Yes: Espray para dormir, Cápsulas para dormir.

Yes, we ship to Malta, and melatonin is straightforward here.

Malta sets no maximum dose for melatonin in food supplements, so there is no national figure for our 1 mg to sit inside or outside. Our dose is also exactly the amount the EU-authorised sleep claim is conditioned on, which makes it the standard dose rather than an unusual one.

Maltese practice bears that out - melatonin is sold openly there as an over-the-counter supplement at 1 mg and above, including on the Maltese site of a mainstream high-street health retailer, with no prescription needed. We are inside established local practice rather than at its edge.

We used to be more cautious on this page, because we had not found positive confirmation of how Malta treats melatonin and preferred to say so. We have now found it. The one thing we would still like is a direct statement from the Malta Medicines Authority, and we will say so here if it changes anything.

Perspectivas

Malta sets no maximum for melatonin in food supplements, and nothing suggests one is coming. The question that used to sit open here - whether Malta quietly treated melatonin as a prescription medicine, as some countries do - is now answered by the market practice described above rather than on paper.

What would settle it completely is a direct statement from the Malta Medicines Authority on how it classifies melatonin, and we will update this page if it says something unexpected. Failing that, EU-level harmonisation of melatonin limits would resolve it for every member state at once.