Brubru EU Canon
Directive 2004/24/EC
The simplified registration that lets herbal medicines with a long history of safe use reach the EU market without full efficacy trials.
Many herbal medicines have been used for generations but cannot prove efficacy with clinical trials, so they could not get a normal marketing authorisation. Directive 2004/24/EC, which amends the Community Code (Directive 2001/83/EC), creates a simplified traditional-use registration so these products can stay on the market lawfully, with full quality and safety controls but long-standing use standing in for trial evidence of efficacy.
It inserts a new Chapter 2a (Articles 16a to 16i) into the Code and adds four definitions: traditional herbal medicinal product, herbal medicinal product, herbal substances and herbal preparations.
A herbal medicine qualifies for traditional-use registration (Article 16a) if it: is for indications suitable for use without a doctor's supervision; has a specified strength and posology; is taken orally, externally or by inhalation; has completed the traditional-use period; and has sufficient, non-harmful, plausible traditional-use data.
Pre-clinical and clinical efficacy data are not required: long use makes efficacy plausible. Quality is not relaxed: the usual physico-chemical, biological and microbiological tests and European Pharmacopoeia standards still apply, and the authorities can always ask for safety data.
The signature requirement (Article 16c): bibliographic or expert evidence that the product, or a corresponding product, has been in medicinal use for at least 30 years, including at least 15 years within the Community. Use does not need to have rested on a formal authorisation, and the threshold still counts if the number or quantity of ingredients was reduced over that time. Where there are fewer than 15 years of EU use, the case is referred to the herbal committee.
The directive establishes the Committee for Herbal Medicinal Products (HMPC) within the EMA (Article 16h): one member and one alternate per Member State for a renewable three-year term, plus up to five co-opted experts. The HMPC draws up Community herbal monographs and a EU list of herbal substances; products that rely on a monograph or a listed substance benefit from mutual recognition and reduced data requirements (Articles 16d, 16f).
Every traditional herbal medicine must state on its labelling, leaflet and advertising that it is "a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use", with advice to consult a doctor if symptoms persist (Article 16g). This keeps patients clear that the basis is tradition, not trial-proven efficacy.
| Instrument | Directive 2004/24/EC (amends Directive 2001/83/EC) |
| Official Journal | L 136, 30 April 2004, p. 85 |
| Legal base | Article 95 TEC (now Article 114 TFEU) |
| Adopted | 31 March 2004 |
| Transposition deadline | 30 October 2005 |
| Transitional period | 7 years for products already on the market |
| Evidence threshold | 30 years of use, including 15 years in the EU |
| New EMA committee | Committee for Herbal Medicinal Products (HMPC) |
A directive is not directly applicable: each Member State must write it into its own national law by a transposition deadline. For the Traditional Herbal Medicines Directive (Directive 2004/24/EC) the EU transposition deadline was 30 October 2005. The map shows, for each Member State, the principal national measure it notified to the Commission and its date. 24 of 27 Member States have notified measures parsed here; the full, authoritative list of national transposition measures for every Member State is on EUR-Lex (National transposition measures).
Click a Member State marker for the transposed national law and its publication date. Source: EUR-Lex National Implementing Measures, retrieved 26 May 2026. Where a marker reads "Notified via EUR-Lex", consult the EUR-Lex link above for that country's measures.
Brubru is the AI policy assistant for the EU bubble. Chat, track, draft, comply.
Try Brubru free