Traditional Herbal Medicinal Products: How Registration Works in the EU and UK
How the EU and UK let some herbal medicines be registered on the basis of long-standing use, what that does and does not prove, and what the label mark means.
Content last updated . This page has not been medically reviewed.
Safety first. Supplements can cause side effects and interact with medicines. Read mushroom safety and interactions before you use any mushroom product.
This page is about how herbal medicines are registered in the European Union (EU) and the United Kingdom (UK). A registration based on traditional use tells you that a regulator looked at the quality of a product and at evidence of long use. It does not tell you that clinical trials showed the herb works. Rules in other countries differ; see the country comparison.
How the sources define the terms
- Traditional use registration (EU). The EMA describes this pathway as one where no clinical tests and trials on safety and efficacy are required, as long as sufficient safety data and plausible efficacy are demonstrated. [1]
- Traditional herbal registration, THR (UK). The MHRA, the UK medicines regulator, says a THR must be obtained before a traditional herbal medicinal product is marketed in the UK. [2]
- Well-established use (EU). A separate EU route relies on published scientific literature showing the active substances have been in medicinal use within the EU for at least ten years, with recognised efficacy and an acceptable level of safety. [1]
- EU herbal monograph. A scientific summary prepared by the EMA's Committee on Herbal Medicinal Products (HMPC) on a herbal substance, covering uses and safe conditions. It is not the same thing as a European Pharmacopoeia monograph, which sets quality requirements. [1]
What each route requires
| Question | EU (EMA, national authorities) | UK (MHRA) |
|---|---|---|
| Length of use | At least 30 years, including at least 15 years within the EU. [1] | At least 30 years; for the whole UK or Northern Ireland, at least 15 of those years in the EU/EEA. [2] |
| Flexibility on the 15 years | Not described in the sources we read. | For products sold in Great Britain only, the MHRA may accept the 15 years from a wider range of countries. [2] |
| Clinical trials | Not required if safety data and plausible efficacy are shown. [1] | Not described in the sources we read; a safety review with an expert report is required. [2] |
| Type of condition | Used without the supervision of a medical practitioner; not given by injection. [1] | Minor conditions where medical supervision is not required (the MHRA gives a cold as an example). [2] |
| Quality | A full quality dossier is required for all herbal medicinal products. [1] | A technical dossier on the quality of the herbal ingredients is required. [2] |
| Who licenses | Mostly national authorities; most individual products are licensed nationally. [1] | MHRA. [2] |
What a traditional registration does and does not mean
What it shows (documented). The regulator reviewed quality information and evidence of long use, and judged the intended use not to need medical supervision. [1]What it does not show. The EMA's public summary for matricaria flower (the flower heads of Matricaria recutita, also known as chamomile) is a clear example. The HMPC based its conclusions on traditional use, which it explains as meaning that, although there is insufficient evidence from clinical trials, the effectiveness is plausible and the herb has been used safely this way for at least 30 years. [3] That is a different evidence label from "tested in trials". Treat it as traditional use only rather than established evidence.
One preparation at a time. A registration covers a named herbal preparation for named uses. It does not carry over to other forms of the same plant, such as a stronger extract or a different part of the plant.
The label mark in the UK
The MHRA says the THR Certification Mark on the label and leaflet is there to show the product meets the required standards of quality, safety and evidence of traditional use. [2] It is not a statement that clinical trials proved a benefit.The EU list and monographs
The HMPC writes EU monographs and drafts an EU list of herbal substances, preparations and combinations for use in traditional herbal medicinal products. [4] Companies can use these as reference material, and if a product complies with the EU list, no further evidence of safe and traditional use is required. [1] More on monographs is on the monographs page.Frequently asked questions
What is a traditional herbal medicinal product?
In the EU it is a herbal medicine registered on the basis of at least 30 years of use, including at least 15 years in the EU, with sufficient safety data and plausible efficacy, and without clinical trials of safety and efficacy. [1]
Does a traditional herbal registration mean the herb has been proven to work?
No. The EMA describes traditional-use conclusions as based on plausible effectiveness and long use, with insufficient evidence from clinical trials. [3]
What is a THR in the UK?
A traditional herbal registration is the approval the MHRA requires before a traditional herbal medicinal product can be marketed in the UK. It is only granted for minor conditions where medical supervision is not required. [2]
Do these rules apply to herbal supplements in the United States?
No. The US uses a different system for dietary supplements. See US regulation of herbal supplements.
Are registered herbal medicines tested for quality?
The EMA says a full quality dossier is required for all herbal medicinal products, and the MHRA requires a quality dossier for THR applications. [1][2] Quality testing of supplements is covered on the quality and certifications page.
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Limits and uncertainty
- This page covers EU and UK medicines rules only. How food supplements are handled in each country is not covered by the sources used here.
- We did not read the national rules of individual EU member states, so details can differ.
- Proper evidence not found: we searched the EMA and MHRA pages above for the number of products registered under each route today and did not find a figure we could read.
Safety and who should ask a clinician
References
- European Medicines Agency (EMA). Herbal medicinal products (regulatory overview). Read 2026-10-23.
- Medicines and Healthcare products Regulatory Agency (MHRA), UK. Apply for a traditional herbal registration (THR). Page last updated 5 January 2024. Read 2026-10-23.
- European Medicines Agency (EMA). Matricaria flower (herbal medicine summary for the public). Read 2026-10-23.
- European Medicines Agency (EMA). Committee on Herbal Medicinal Products (HMPC). Read 2026-10-23.