Guidance

Apply for a traditional herbal registration (THR)

• From: Medicines and Healthcare products Regulatory Agency
• Part of: Traditional herbal medicines: registration form and guidance, Patient safety, and Herbal and homeopathic medicines
• Published: 31 December 2014
• Last updated: 22 September 2016, see all updates

How to apply for a traditional herbal registration (THR) to market a herbal medicine (remedy) in the UK.

You must apply for a traditional herbal registration (THR) before you can market a herbal medicine 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 medicine 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 THR 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 medicines
• 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 and working towards statutory regulation of herbal medicine profession
• draft summary of product characteristics according to the European Commission’s guidelines
• a mock up label and patient information leaflet (PIL): see best practice guidelines on this
• proof of payment

You can request a meeting before you submit your application for advice on whether your product is likely to meet the THR requirement by completing the template for notification of application for THR (MS Word Document, 341KB) 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, 26.9KB, 5 pages) on the usage of the mark.

Submit your application

Submit your application form with the required documents via the MHRA Portal or through the Common European Submission Portal (CESP).

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 Area1-INITIALS-submission-queries@mhra.gov.uk if you have any questions about submitting your application.

MHRA usually takes 210 days to evaluate your application if we receive all the required documents and they are valid .

Submissions through the Common European Submission Portal (CESP)

This system is available from the Heads of Medicines Agencies (HMA) and provides a simple and secure mechanism for exchange of information between applicants and regulatory agencies.

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 CESP user and wish to setup up an organisation/university or trust to manage multiple users on the system, register with CESP here.

If you are a standalone user and wish to upload for Non Commercial Use on your own behalf, register with CESP here.

Once registered you will receive credentials to access the portal to your registered email address.

General CESP training is available to all registered users via CESP’s training menu once logged into the system. Training on demand videos are available and you can also sign up to our free online weekly live demonstrations. CESP encourage all users to attend training before using the system. View FAQs here.

Fees

Fees for the THR scheme

You need to pay for the THR before you submit your application, ensuring you provide proof of payment if you haven’t already.

Herbal medicine: definition

According to the Human Medicines Regulation (2012), a product is a herbal medicine if the active ingredients are herbal substances and or herbal preparations only.

A 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 (PDF, 161KB, 24 pages) before applying for a THR.

See list of herbal medicines granted a THR.

Eligibility for THRs

You must ensure the indication of the herbal medicine is agreed under legislation. The indication is the medical condition the product has traditionally been used to treat. Check the permitted indications (PDF, 199KB, 7 pages) to see if your herbal product is eligible under the directive on traditional herbal products.

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, 15 years of which must have been in the European Union (EU). See guidance on producing evidence to show traditional use and safety (PDF, 157KB, 4 pages) of the product.

Follow the guidance on demonstrating safety and traditional use with monographs by the Committee on Herbal Medicinal Products (HMPC) (PDF, 43.3KB, 1 page) if you want to use this type of evidence.

Banned or restricted 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 legal.

Exemptions for THR

If you’re a herbal practitioner, you don’t need a licence to supply herbal medicines you create on your premises to patients following one-to-one consultations.

More information

See directive 2004/24/EC on the European Commission’s website for the legislation on traditional herbal medicines.

To cancel a THR licence or withdraw a pending submission, follow the guidance on cancellations. To renew your THR see the renewals guide

Document information

Published: 31 December 2014

Updated: 22 September 2016

+ full page history

1. 22 September 2016 Added guidance on the usage of the THR Certification Mark.
2. 31 December 2014 First published.

From: Medicines and Healthcare products Regulatory Agency

Part of: Traditional herbal medicines: registration form and guidance Patient safety Herbal and homeopathic medicines