Is Melatonin legal in Czechia?

Formal status

There is no EU-harmonised rule on melatonin in food supplements. It is governed nationally, and member states differ widely - from outright medicine-only treatment to permitted doses of several milligrams. That absence of a common rule is itself the correct starting point.

Czechia sets no limit in food law. Melatonin appears nowhere in the food supplements decree, neither among the permitted substances with maximum daily doses nor among the prohibited ones.

The line is drawn by the medicines agency instead. Since a change of practice announced on 14 March 2023, the agency regards orally administered products containing 0.5 mg or more of melatonin per daily dose as medicinal products, on the basis of the substance's pharmacological effects at that level. Products below 0.5 mg are not treated as medicines, because the resulting blood levels are close to those following consumption of certain foods.

That position has been tested and upheld. On 20 May 2021 the Municipal Court in Prague dismissed a challenge and confirmed the classification of a 1.5 mg melatonin product as a medicinal product.

Melatonin is separately available in Czechia as a registered prescription medicine at 2 mg in prolonged-release form.

Do we sell here?

Yes, for now: Sleep spray, Sleep capsules.

Yes, we ship to Czechia, and melatonin is the part of that decision we want to be most straightforward about.

Czechia draws its line at 0.5 mg. Above that, its medicines regulator treats an oral melatonin product as a medicine rather than a supplement, a position a Czech court upheld in 2021. Our formula delivers 1 mg, which is twice that. Czech brands work visibly around the line - one well-known product is a 1.99 mg tablet with instructions to take a quarter of it.

So we are not going to claim our dose sits comfortably inside Czech rules. It does not. What we weigh is that the regulator's decisions in this area have consistently been directed at companies established in Czechia, that its power to have websites blocked has never been used against a supplement seller of our kind, and that a European company which is identifiable, publishes its testing and answers regulators is in a very different position from the anonymous operators that power is aimed at.

That is a judgement, not a guarantee. If it stops holding, we will say so here and stop shipping.

Outlook

The 0.5 mg line has been stable since 2023, has been upheld in court, and the Czech market has organised itself around it in a very visible way. Movement is unlikely.

The more interesting question is enforcement reach rather than the threshold. The medicines agency operates a statutory list that obliges internet providers to block listed websites, and it maintains a separate published warning list with no such effect. Melatonin sellers have appeared on the warning list but never on the blocking list. Whether that distinction holds is the thing to watch, and it would be an early signal well before anything reached us.

An EU-level harmonisation of melatonin in supplements would resolve this and several other countries at once, but none is proposed.

Timeline

May 2020

SÚKL adds vitaminnatural.com/cs/ to its published warning list of websites making illegal offers of unapproved preparations, itemising nine melatonin supplements (Natrol 3 mg, 1 mg time-release, 10 mg, 3 mg TR, 5 mg TR and others) offered to Czech consumers. This warning list is a separate register from SÚKL's statutory blocking list under §§ 101a and 101c of zákon č. 378/2007 Sb. and carries no ISP-blocking obligation — it is publication only.

SÚKL — Internetové stránky s nelegálními nabídkami neschválených přípravků

November 2020

SÚKL reclassifies "Melatonin 1 mg sprej" (BENEPHARMA CZ spol. s r.o., Prague) as a medicinal product and orders that it be immediately returned to the supplier. The product is an oral melatonin spray delivering 1 mg per dose — the same format and the same dose as Gavarres Sleep Spray.

SÚKL — Výrobky přeřazené do skupiny léčiv

May 2021

Městský soud v Praze, judgment č. j. 6 Ad 1/2019-75, dismisses the action and upholds the classification of the product "Melatonin Mučenka Meduňka B6", containing 1.5 mg melatonin, as a medicinal product under § 2(1) of zákon č. 378/2007 Sb. This is the judicial confirmation SÚKL relies on for its practice.

Městský soud v Praze, 6 Ad 1/2019-75

August 2022

Zákon č. 247/2022 Sb., published 31 August 2022 and in force 1 October 2022, inserts §§ 3b–3d into zákon č. 146/2002 Sb. SZPI may enter a website on a published register by administrative decision under § 3c(1), with the site's operator as a named party and a right of appeal; where the operator cannot be identified they are designated as the domain-name holder and served by public notice. Under § 3d, providers of internet access in Czechia must then block the listed site within 15 days.

Zákon č. 247/2022 Sb. (zakonyprolidi.cz)

March 2023

SÚKL announces a change of decision-making practice on melatonin: "považuje SÚKL výrobky, které se podávají perorálně a obsahují v denní dávce 0,5 mg melatoninu a více, za léčivé přípravky" under § 2(1)(b) of zákon č. 378/2007 Sb. Products below 0.5 mg per oral daily dose are not treated as medicines, because resulting serum levels are close to those following consumption of certain foods.

SÚKL