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 the Registration Application Form with with the required documents through through MHRA submissions.

You need to submit your application using the the eCTD format. If you can’t use eCTD you can use the Non-eCTD electronic Submissions (NeeS) process.

Email Email RIS.NA@mhra.gov.uk if 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 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 the training webinar recording. We encourage all users to review training material before using the system.

You should use our our eAF and cover letter tool to 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, (PDF, 95 95KB, 7 KB, 7 pages)pages)

Fees

Fees for the Simplified Homeopathic Registration Scheme

Fees for the UK Homeopathic National Rules Scheme

Use the the Fees Calculator to 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 substances,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.Regulations and is summarised as follows.

ForProducts homeopathicregistered productsunder 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.

ForProducts homeopathicregistered productsunder the Simplified Registration Scheme marketed in Great Britain only

Products must be prepared from homeopathic stocks made followingin accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia,Pharmacopoeia oror, in the absence of a description there, in accordance with a procedure described in the British Pharmacopoeia or in a pharmacopeiapharmacopoeia used officially in a country that is included in a list published by the MHRA.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, (PDF, 54.8 54.8KB, 1 KB,page)

Products 1authorised page)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, (PDF, 94.8 94.8KB, 7 KB,pages)

Guidance 7on pages)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, (PDF, 131 131KB, 4 KB, 4 pages)pages)

The control and quality of homeopathic stocks (PDF, (PDF, 106 106KB, 4 KB, 4 pages)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, (PDF, 160 160KB, 12 KB, 12 pages)pages)

Contact

Windsor Framework

info@mhra.gov.ukList of products assigned Category 2

020Information 3080and 6000