Guidance

Register a homeopathic medicine

Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme

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

Submit the homeopathic application form (PDF, 1.12MB, 24 pages) 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 IPUenquiries@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, 72.9KB, 8 pages)

Fees

Fees for the Simplified Homeopathic Registration Scheme

Fees for the UK Homeopathic National Rules Scheme

Make a payment to the MHRA

Description of homeopathy

Homeopathy is a system of medicine which involves treating the individual with diluted substances, given mainly in tablet form.

The definition of a homeopathic medicinal product is given in the Human Medicines Regulations.

For homeopathic products 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.

For homeopathic products marketed in Great Britain 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 a country that is included in a list published by the MHRA.

List of pharmacopoeias published by MHRA (PDF, 54.8KB, 1 page)

Further information

Labelling requirements for homeopathic products (PDF, 94.8KB, 7 pages)

The Simplified Homeopathic Registration Scheme and UK Homeopathic National Rules Scheme

The manufacture and control of dosage forms for homeopathics (PDF, 131KB, 4 pages)

The control and quality of homeopathic stocks (PDF, 106KB, 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, 160KB, 12 pages)

Contact

info@mhra.gov.uk

020 3080 6000

Homeopathics Unit
MHRA
10 South Colonnade
London
E14 4PU

Published 20 January 2015
Last updated 18 May 2021 + show all updates
  1. Updated link to 'Homeopathic registrations/authorisations granted by MHRA' pdf.

  2. Updated to reflect changes to regulations after Brexit transition.

  3. Changed MHRA address.

  4. Updated the list of Homeopathic registrations/authorisations granted by MHRA

  5. Updated description of Homeopathy.

  6. Revised definition of homeopath added to the page.

  7. Added an updated homeopathic registration and national rules authorisation form to the page.

  8. updated HR & NR listing document added

  9. Updated list of registered homeopathic products.

  10. First published.