Medicines, medical devices and blood regulation and safety – guidance

Register a homeopathic medicine or remedy

How to register your homeopathic product through the simplified scheme or national rules scheme: criteria, costs and application forms.

Overview

In the UK there are 2 regulatory schemes for homeopathic medicines:

  • the simplified registration scheme
  • the national rules scheme

Under the simplified 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 registration under the simplified 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 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

National applications

Submit the homeopathic application form (PDF, 1.12MB, 24 pages) online using the MHRA portal.

If you are not registered with the portal or can’t make your submission electronically you can send MHRA your application on CD or DVD. Please note that MHRA will no longer accept submissions on physical media from 1 February 2016.

European applications

If you want to market your product in Europe you should submit an application through the Common European Submissions Platform (CESP).

Registered or a national rules authorisation products

Homeopathic registrations/authorisations granted by MHRA (PDF, 54.9KB, 8 pages)

Fees

Fees for the simplified scheme

Fees for the national rules scheme

Make a payment to MHRA

Description of homeopathy

Homeopathy is a system of medicine which involves treating the individual with highly diluted substances, given mainly in tablet form, with the aim of triggering the body’s natural system of healing. Based on their specific symptoms, a homeopath will match the most appropriate medicine to each patient.

All homeopathic products must comply with the definition given in EU Directive 2001/83/EC

Further information

Labelling requirements for homeopathic products (link to report)

The simplified scheme

The manufacture and control of dosage forms for homeopathics (PDF, 112KB, 4 pages)

The control and quality of homeopathic stocks (PDF, 115KB, 4 pages)

Guidance on Module 3 of the homeopathic medicinal products dossier

Points to consider on stability testing of homeopathic medicinal products

The national rules scheme

The homeopathic national rules scheme: brief guidance for manufacturers and suppliers (PDF, 56.7KB, 10 pages)

The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006 - SI 2006 No 1952

Contact

info@mhra.gsi.gov.uk 020 3080 6000

Homeopathics Unit
MHRA
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ