Legal status (NL/EU)

When is something a medicine?

Under European and Dutch law, a medicine is defined not by what is in the vial but by how it is presented and used. A substance presented as a means to treat or prevent a condition, or administered for that purpose, falls under medicines legislation — regardless of its label. Placing a medicine on the market requires a marketing authorisation.

What "research use only" does and does not mean

The label research use only (RUO) indicates that a product is intended for laboratory research and not for use in humans or animals. It is a usage restriction, not a legal status that places a substance outside regulation. If an RUO product is in fact offered or used for administration to people, the legal assessment changes: in substance it then concerns an unauthorised medicine.

Supervision in the Netherlands

Several authorities play a role:

• the CBG (Medicines Evaluation Board) assesses medicines for the Dutch market;
• the IGJ (Health and Youth Care Inspectorate) supervises compliance;
• the NVWA acts where products are presented as food or supplements;
• at European level the EMA assesses medicines for the whole Union.

Claims and advertising

Communication is regulated separately from the substance itself. Advertising unauthorised medicines is not permitted, and health claims may not simply be attached to products. That is why this site consistently describes what has been researched, without promising results.

Sport and doping

Athletes subject to anti-doping rules must also observe the prohibited list of the World Anti-Doping Agency (WADA). Alongside specifically named substances it includes categories, among them substances without approval for human use.

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See also: Quality & provenance, Glossary.