UK Regulatory Guidance on Traditional Herbal and Homeopathic Medicinal Products

1. Overview

The Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on how traditional herbal medicinal products (THR) and homeopathic medicinal products are registered and regulated in the UK. This reflects the application of the Human Medicines Regulations 2012 and subsequent amendments, and clarifies that certain changes introduced by the Windsor Framework for medicinal products do not impact these categories of products.
Source: Guidance on new provisions for traditional herbal medicinal products and homeopathic medicinal products (gov.uk)

2. Traditional Herbal Medicinal Products (THR)

Under the Human Medicines Regulations, a traditional herbal medicinal product is defined as a medicinal product where the active ingredients are herbal substances and/or herbal preparations only. Vitamins and minerals may be included only if their action is ancillary to the herbal ingredients with respect to the claimed indication(s).
Source: Guidance on new provisions … (gov.uk)

2.1 Registration and Traditional Use Evidence

For a traditional herbal product to be registered under the Traditional Herbal Registration (THR) scheme, it must demonstrate a history of traditional use. Although some Windsor Framework changes affect broader human medicines regulation from 1 January 2025, the provisions for THR products remain unchanged; evidence of traditional use accepted by the MHRA may come from a wider list of countries with a pharmacovigilance system equivalent to the UK for products marketed only in Great Britain. MHRA may publish and update this list as needed.
Source: Guidance on new provisions … (gov.uk)

2.2 Geographic Scope

These expanded provisions do not apply to traditional herbal medicines intended for Northern Ireland or UK-wide registrations. In those cases, product applicants must provide EU/EEA traditional use evidence for at least 15 years of use of the product or corresponding product.
Source: Guidance on new provisions … (gov.uk)

3. Homeopathic Medicinal Products

Homeopathic medicinal products are also regulated under UK law and require registration with the MHRA’s simplified registration scheme. Similar to THR products, homeopathic medicines fall outside the scope of the Windsor Framework changes and are therefore not impacted by the post-Brexit regulatory shifts for human medicines.
Source: Guidance on new provisions … (gov.uk)

Information on the specific process for homeopathic registration can be found in the separate MHRA document Register a homeopathic medicine.
Source: Guidance on new provisions … (gov.uk)

4. Practical Implications

The guidance confirms that the regulatory framework for THR and homeopathic products continues to require that such products are appropriately registered and meet statutory safety and quality standards. While traditional herbal products use evidence of long-standing use rather than rigorous clinical efficacy data, they must still satisfy MHRA criteria for registration before placement on the UK market.
Source: Guidance on new provisions … (gov.uk)

5. Regulatory Status Summary

• THR products: Registered under the THR scheme; may use expanded evidence sources for traditional use in Great Britain, but must rely on EU/EEA traditional use evidence for Northern Ireland or UK-wide cases.
• Homeopathic products: Registered via the MHRA’s homeopathic scheme; unaffected by the Windsor Framework changes.
  Source: Guidance on new provisions … (gov.uk)

6. Conclusion

The MHRA’s guidance on traditional herbal and homeopathic medicinal products ensures that the regulatory processes for these categories remain clear and consistent with existing UK law, even as broader human medicines regulations evolve. Stakeholders should continue to follow existing registration pathways and evidence requirements specific to each product type.
Source: Guidance on new provisions … (gov.uk)