Traditional Herbal Medicinal Products in the EU: How "Traditional Use" Registration Works

What the registration is

A "traditional herbal medicinal product" is a herbal medicine sold on the basis of long-standing use rather than new clinical trials. In the European Union, a simplified registration route for these products was introduced in 2004 through Directive 2004/24/EC, known as the Herbal Directive. [1] The European Medicines Agency (EMA) describes it as one of three main pathways for bringing herbal products to market. [1] This page explains the rules as the regulators describe them. It is not advice about any product.

The three EU pathways

What traditional use registration requires

• Time in use: the product must have been used for at least 30 years, including at least 15 years within the EU. [1] For this rule the EU includes the countries of the European Economic Area. [2]
• Evidence type: assessment of mostly published (bibliographic) safety and efficacy data. [1]
• Self-care use: products are meant to be used without the supervision of a medical practitioner and are not given by injection. [1]
• Full quality dossier: quality requirements are not relaxed. A full quality dossier is required for all herbal medicinal products. [1]
• Plant-based only: active ingredients must be herbal substances or preparations. Substances of synthetic origin are not acceptable as active ingredients. [2]

Registration is handled by the national authority of each Member State, and most herbal products continue to be licensed nationally. [1]

Monographs and the EU list

The EMA's Committee on Herbal Medicinal Products (HMPC) establishes EU monographs on the therapeutic uses and safe conditions of well-established or traditional use of herbal substances. [3] It also drafts an EU list of herbal substances for traditional products. A company whose product complies with the EU list does not need to supply further evidence of safe and traditional use. [1] Monographs are a regulatory reference. They are not the same as European Pharmacopoeia quality monographs. [1]

What "traditional use" does and does not mean

The EMA's own questions and answers say that, for these products, the approach rests on medicinal traditional usage and not on proven efficacy. [2] So a registered product has met a quality and safety standard and has a documented history. That is different from evidence from controlled trials that it works. This is the "historical use is not clinical evidence" distinction explained on historical use vs clinical evidence.

The legislation has no special provisions for Ayurvedic products. They must meet the same requirements as other traditional herbal products. [2] For how the rules treat other traditions, see how traditional medicines are regulated by country and pharmacopoeias and herbal monographs.

The UK scheme: THR

After Brexit the UK runs its own Traditional Herbal Registration (THR), administered by the MHRA. You must hold one before marketing a traditional herbal medicinal product in the UK. [4] Key points:

• It is granted only where the medicine is for minor health conditions that do not need medical supervision, such as a cold. Products claiming to treat major conditions need a marketing authorisation. [4]
• Applications must include evidence on safety, quality and traditional use. The MHRA usually takes 210 days to evaluate a complete application. [4]
• Products carry a THR certification mark on the label and leaflet. [4]
• For products registered only in Great Britain, the rules accept 15 years of traditional-use evidence from a wider range of countries, in addition to the EU/EEA, where pharmacovigilance is equivalent to the UK's. [5]
• Registration of traditional herbal medicines falls outside the scope of the Windsor Framework. [5]

The MHRA publishes a list of herbal medicines holding a THR. [6] The NHS advises checking for the THR mark and product code, and not buying unlicensed herbal medicines online. [7]

Registered medicine, supplement or neither

Not all herbal products are medicines; some are classed as food supplements or cosmetics. [4] A food supplement is regulated under different rules. In the US, herbal products are generally sold as dietary supplements. [8] See how supplements are regulated.