# Register a homeopathic medicine Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/39009ae1-98a8-45c7-98a4-ff905f128496 Type: Detailed Guide Published: January 20, 2015 Updated: December 11, 2025 > This regulatory guidance issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the compliance requirements for marketing homeopathic medicinal products via two distinct pathways: the Simplified Registration Scheme and the National Rules Scheme. Operating under Regulation 8 of the Human Medicines Regulations, the Simplified Registration Scheme is restricted to products for oral or external use that are diluted by at least 1 in 10,000, ensuring safety while prohibiting any therapeutic claims. In contrast, the National Rules Scheme allows for the treatment of minor conditions based on UK homeopathic traditions without dilution limits, provided safety and quality data are supplied. Key regulatory considerations include adherence to the Windsor Framework, which requires 'UK Only' labeling for National Rules products, and compliance with the British or European Pharmacopoeia. To fulfill required actions, applicants must submit documentation through the MHRA electronic portal using eCTD or NeeS formats. Manufacturers are responsible for providing comprehensive data on manufacturing procedures, stability testing, and labeling literature. Failure to submit accurate data or utilize the correct electronic application forms will prevent application validation. The MHRA estimates a 210-day evaluation period for valid submissions, and companies must use the official fee calculator to ensure correct payment. While no specific company violations are noted in this general guidance, strict adherence to these submission and labeling protocols is mandatory for all UK homeopathic suppliers. --- ## Content Overview In the UK there are 2 regulatory schemes for homeopathic medicinal products: the Simplified Registration Scheme the National Rules Scheme Under the Simplified Registration Scheme, you must submit data on the quality of the product and show that it is dilute enough to guarantee safety. The first dilution to be registered must be at least a 1 in 10,000 dilution of the starting material. The Scheme does not allow indications (description of diseases or conditions for which the product is used for). To qualify for the Simplified Registration Scheme, the products must: be for oral or external use (excluding injections) be sufficiently dilute to guarantee safety make no therapeutic claims Under the National Rules Scheme there is no restriction on the first dilution to be authorised or the pharmaceutical form. You can claim that your product is used within the UK homeopathic tradition for the relief or treatment of minor symptoms and conditions which don’t require the supervision of a doctor. You must submit data that demonstrates quality, safety and use within the UK homeopathic tradition and you must include details of your labelling and product literature with your application. How to apply For initial, variation and renewal applications, submit the Registration Application Form with the required documents through 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 RIS.NA@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 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 in 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. Products with a Simplified Homeopathic Registration certificate or UK Homeopathic National Rules authorisation Homeopathic registrations/authorisations granted by MHRA (PDF, 95 KB, 7 pages) Fees Fees for the Simplified Homeopathic Registration Scheme Fees for the UK Homeopathic National Rules Scheme Use the Fees Calculator to work out what the fee for your submission will be. Make a payment to the MHRA Description of homeopathy Homeopathy is a system of medicine which involves treating the individual with diluted or undiluted homeopathic stocks, given mainly in tablet or pillule form. The definition of a homeopathic medicinal product is given in Regulation 8 of the Human Medicines Regulations and is summarised as follows. Products registered under the Simplified Registration Scheme marketed in the whole of the UK or Northern Ireland only Products must be prepared from homeopathic stocks made following a homeopathic manufacturing procedure described in the European Pharmacopoeia, or in the absence of a description there, the British Pharmacopoeia or a pharmacopeia used officially in an EEA State. Products registered under the Simplified Registration Scheme marketed in Great Britain only Products must be prepared from homeopathic stocks made in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia or, in the absence of a description there, in accordance with a procedure described in the British Pharmacopoeia or in a pharmacopoeia used officially in a country that is included in a list published by the MHRA. The list includes: British Pharmacopoeia European Pharmacopoeia pharmacopoeia used officially in an EEA state The above list will be updated as new entries arise. List of pharmacopoeias published by MHRA (PDF, 54.8 KB, 1 page) Products authorised under the Homeopathic National Rules Scheme Products are authorised on a UK-wide basis. Products must be prepared from homeopathic stocks made following a homeopathic manufacturing procedure described in the European Pharmacopoeia, or in the absence of a description there, the British Pharmacopoeia or a pharmacopeia used officially in an EEA State. Windsor Framework Products authorised under the National Rules Scheme must state “UK Only” on the outer label and are assigned Category 2. Products registered under the Simplified Homeopathic Scheme fall outside the scope of the framework and are not categorised. Further information Labelling requirements for homeopathic products (PDF, 94.8 KB, 7 pages) Guidance on new provisions for traditional herbal medicinal products and homeopathic medicinal products following agreement of the Windsor Framework (PDF 4 pages) The Simplified Homeopathic Registration Scheme and UK Homeopathic National Rules Scheme The manufacture and control of dosage forms for homeopathics (PDF, 131 KB, 4 pages) The control and quality of homeopathic stocks (PDF, 106 KB, 4 pages) Guidance on Module 3 of the homeopathic medicinal products dossier Points to consider on stability testing of homeopathic medicinal products The UK Homeopathic National Rules Scheme The homeopathic national rules scheme: brief guidance for manufacturers and suppliers (PDF, 160 KB, 12 pages) Windsor Framework List of products assigned Category 2 Information and guidance on the main changes introduced by the Windsor Framework agreement ## Attachments - [Registration Application Form](https://assets.publishing.service.gov.uk/media/640720fde90e0740e04f41fb/Registration_application_form_for_a_THR.doc) - [Homeopathic registrations/authorisations granted by MHRA](https://assets.publishing.service.gov.uk/media/693961aa7a605b2d61cd904b/Granted_HR__NR_listing_with_product_name_09-12-2025.pdf) - [Labelling requirements for homeopathic products](https://assets.publishing.service.gov.uk/media/681e0403c66deec8488f7e97/Labelling_requirements_for_homeopathic_products_updated_April_2025_.pdf) - [The manufacture and control of dosage forms for homeopathics ](https://assets.publishing.service.gov.uk/media/5ff6f4a8e90e0763a8db9715/The_manufacture_and_control_of_dosage_forms_for_homeopathics_Jan_1_2021.pdf) - [The control and quality of homeopathic stocks](https://assets.publishing.service.gov.uk/media/5ff6f4bb8fa8f53b772750df/The_control_and_quality_of_homeopathic_stocks_Jan_1_2021.pdf) - [The homeopathic national rules scheme: brief guidance for manufacturers and suppliers](https://assets.publishing.service.gov.uk/media/681e0413f16c0654b190607d/The_homeopathic_national_rules_scheme_guidance_for_manufacturers_and_suppliers_updated_April_2025_.pdf) - [List of pharmacopoeias published by MHRA](https://assets.publishing.service.gov.uk/media/5fe359d68fa8f56af2a85fd8/Pharmacopoeias_included_in_the_MHRA_list.pdf)