When does something legally count as a medicine?

The Swedish Medicinal Products Act (läkemedelslagen 2015:315), chapter 2 section 1, defines a medicine as any substance or combination of substances that is either presented as having properties for preventing or treating disease in humans or animals, or that can be used on or given to humans or animals in order to restore, correct or modify bodily functions through a pharmacological, immunological or metabolic effect, or to make a diagnosis. The definition has two legs. The first is about what is claimed. The second is about what the product actually does. Only one of them has to be met. A seller can therefore turn their own product into a medicine through marketing alone, whatever the label says.

Chapter 5 section 1 says a medicine may only be sold once it has been approved or registered for sale, is covered by the recognition of an approval in another EEA country, or holds a separate sales licence. Breaking that rule is a criminal offence under chapter 16 section 1, punishable by a fine or up to a year in prison for anyone acting deliberately or negligently. The advertising rules are at least as blunt. Chapter 12 section 1 opens: "Marketing of medicines for human use that have not been approved for sale is prohibited." The same section bans marketing aimed at children and — apart from vaccination campaigns — bans advertising prescription medicines to the general public.

The Swedish Medical Products Agency's remit is set out in Ordinance (2020:57). Section 1 makes it the authority responsible for medicines and medical devices, tasked with working towards safe, effective, good-quality medicines. Section 2 gives it control and supervision over medicines, controlled substances "and certain other products which, by their properties or use, are closely related to medicines". The same section gives it supervision and market surveillance over cosmetics, among other things. That phrase about products "closely related to medicines" is the important one: it is written precisely to catch products parked in a grey zone.

Labels like "research chemical" or "not for human consumption" do not change the legal classification. Swedish Customs puts the principle plainly: a preparation classed as a medicine in Sweden falls under Swedish law regardless of how another country classes it. On importing, Customs states that it is prohibited to buy medicines from a country outside the EEA, and that a private individual may not receive medicines sent from outside the EEA — any medicine, of any kind. From another EEA country an order is possible only if the medicine is approved there, was obtained from a pharmacy or equivalent, and is either available without prescription in Sweden or was prescribed by an authorised prescriber within the EEA. At most a year's supply may be ordered, and it is the recipient who has to prove the conditions are met. Medicines classed as controlled drugs may never be received by post or parcel, and Customs states the same applies to certain medicines classed as doping agents.