Apply for a traditional herbal registration (THR)

AI Summary

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.