# Apply for a traditional herbal registration (THR)

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/57b0279f-2d68-43da-91a8-7755f3389bc6
Type: Detailed Guide
Published: December 31, 2014
Updated: January 5, 2024

> This regulatory guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the requirements for obtaining a Traditional Herbal Registration (THR). Governed by the Human Medicines Regulations 2012, this framework applies to herbal medicinal products intended for minor health conditions that do not require medical supervision. Manufacturers and applicants must submit a comprehensive application via the MHRA Submissions portal, ideally using the electronic Common Technical Document (eCTD) format. Key required actions include providing a technical dossier on quality, an expert safety report authored by a qualified professional, and draft product labeling featuring the THR Certification Mark. Crucially, applicants must provide scientific evidence of at least 30 years of traditional use, with at least 15 of those years within the UK, EU/EEA, or countries with equivalent safety monitoring. The guidance emphasizes that toxic or restricted herbal ingredients are prohibited. While the evaluation process typically takes 210 days, herbal practitioners are exempt from these licensing requirements when providing bespoke products following one-to-one consultations. Failure to provide correct documentation or evidence of traditional use will result in application rejection.

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## Content

You must apply for a traditional herbal registration ( THR ) before you can market a traditional herbal medicinal product in the UK. A THR is only granted if the medicine is used for minor health conditions where medical supervision is not required (e.g. a cold). If your traditional herbal medicinal product claims to treat major health conditions, you need to apply for a marketing authorisation before you can place it on the market. How to apply Complete the application form for a traditional herbal medicine ( PDF , 1.12 MB , 24 pages ) and submit it with the required documents below. Required documents You must include scientific evidence with your application relating to the safety, quality and traditional use of the herbal product. This includes: a technical dossier covering the quality of herbal ingredients in the electronic Common Technical Document ( eCTD ) format for traditional herbal medicinal products review of safety with an expert report including clinical and non-clinical safety areas carried out by either: a registered doctor a registered pharmacist a scientifically qualified competent individual (eg toxicologist) herbal practitioner who is a member of a professional body draft summary of product characteristics a mock-up label and patient information leaflet (PIL): see best practice guidelines on this You can request advice before you submit your application for advice on whether your product is likely to meet the THR scheme requirements by completing the template for notification of application for THR ( MS Word Document , 321 KB ) and emailing it to info@mhra.gov.uk . THR Certification Mark The THR Certification Mark should be included on the mock up label and patient information leaflet to show that the product meets the required standards of quality, safety and evidence of traditional use. See guidelines ( PDF , 22.2 KB , 4 pages ) on the usage of the mark. Submit your application Submit your application form with the required documents via MHRA Submissions . You need to submit your application using the eCTD format . If you can’t use eCTD you can use the Non- eCTD electronic Submissions (NeeS) process. Email IPUenquiries@mhra.gov.uk if you have any questions about submitting your application. The MHRA usually takes 210 days to evaluate your application if we receive all the required documents and they are valid . Submissions through MHRA Submissions Access MHRA Submissions This UK national system is available and provides a simple and secure mechanism for exchange of information between applicants and the MHRA. The purpose of the system is to: provide a secure method of communicating with regulatory agencies via one platform allow submission of an application once to reach all required agencies reduce the burden for both industry and regulators of submitting/handling applications on CD-ROM and DVD If you are a first time MHRA Submission user and wish to register an organisation/university or trust to manage multiple users on the system follow the guidance and register with MHRA Submissions . Once registered you will receive credentials to access the portal to your registered email address. General MHRA Submission training is available to all via the training webinar recording . We encourage all users to review training material before using the system You should use our eAF and cover letter tool to determine what information you need to include in your application. If you do not include the correct information your application will not be validated. Fees Fees for the THR scheme Make a payment to the MHRA . Use the Fees Calculator to work out what the fee for your submission will be. Herbal medicinal product: definition According to the Human Medicines Regulations (2012), a product is an herbal medicinal product if the active ingredients are herbal substances and/or herbal preparations only. An herbal substance is a plant or part of a plant, algae, fungi or lichen, or an unprocessed exudate of a plant, defined by the plant part used and the botanical name of the plant, either fresh or dried, but otherwise unprocessed. An herbal preparation is when herbal substances are put through specific processes, which include: extraction distillation expression fractionation purification concentration fermentation The herbal substance being processed can be: reduced or powdered a tincture an extract an essential oil an expressed juice a processed exudate (rich protein oozed out of its source). Not all herbal products are medicines, some can be classified as food supplements or cosmetics. Check the guide on what is considered a medicinal product before applying for a THR . See the list of herbal medicines granted a THR . Eligibility for the THR Scheme You must ensure the indication of the herbal medicinal product is suitable for the Traditional Herbal Registration Scheme. The indication is the medical condition the product has traditionally been used to treat. Check the permitted indications ( PDF , 154 KB , 6 pages ) to see if your herbal medicinal product is eligible under the Traditional Herbal Registration Scheme. You must also show evidence that the herbal medicinal product has been traditionally used to treat the stated condition for a minimum of 30 years. For products intended to be marketed in the whole of the UK or Northern Ireland only, at least 15 years of the 30 years of use must relate to use in the EU /EEA. For products intended to be marketed in Great Britain (England, Wales and Scotland) only, the MHRA may be able to accept the 15 years of traditional evidence from a wider range of countries in addition to the UK and EU /EEA countries. Suitable countries will be those that have a level of pharmacovigilance equivalent to that of the UK. This is to ensure that any safety issues have been properly identified to support the traditional use of the product. The MHRA will publish a list of suitable countries for this purpose on the gov.uk website and update this list as new entries arise. See guidance on sources of evidence to show traditional use and safety ( PDF , 126 KB , 4 pages ) of the product. Applicants are strongly encouraged to contact the MHRA at an early stage, using our template for notification of application for THR ( MS Word Document , 321 KB ) should they have any questions. Banned or restricted herbal ingredients Some herbal ingredients are toxic and cannot be used in the manufacture, import and sale of unlicensed medicines in the UK. There are also restrictions on how some herbal ingredients can be used in medicines. Check the list of banned and restricted herbal ingredients before you submit your application to ensure your ingredients are acceptable for the Traditional Herbal Registration Scheme. Exemptions for THR If you’re an herbal practitioner, you don’t need a licence to supply herbal medicinal products you create on your premises to patients following one-to-one consultations. More information To cancel a THR licence or withdraw a pending submission, follow the guidance on cancellations . To renew your THR see the renewals guide

## Attachments

- [template for notification of application for THR ](https://assets.publishing.service.gov.uk/media/61239084e90e07054eb85e42/Template_for_pre-application_notification_scheme_230821.docx)
- [application form for a traditional herbal medicine](https://assets.publishing.service.gov.uk/media/5ff49c4b8fa8f53b7f26d6db/Homeopathic_products_application_form.pdf)
- [guidance on sources of evidence to show traditional use and safety](https://assets.publishing.service.gov.uk/media/5fef196de90e0776a0d9cdaa/sources_of_evidence_to_show_traditional_use_and_safety.pdf)
- [permitted indications](https://assets.publishing.service.gov.uk/media/5ff59d858fa8f53b7bad84a9/Guidance_on_Permitted_Indications_FINAL.pdf)
- [Interpretation of Article 23a and Article 24 (4-6) of Directive 2001/83EC (the Sunset Clause)](https://assets.publishing.service.gov.uk/media/5a7c52f340f0b6321db386c1/MHRA-sunset-clause.pdf)
- [guide on what is considered a medicinal product](https://assets.publishing.service.gov.uk/media/5a7cfb8840f0b60aaa2937b2/guide_8_what_is_a_medicinal_product.pdf)
- [guidelines](https://assets.publishing.service.gov.uk/media/5fef1924e90e0776aa141302/The_Traditional_Herbal_Registration__THR__Certification_Mark_Guidance_for_Business.pdf)