Medicines Healthcare Products Regulatory Agency
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 dont 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 cant 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
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.
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.
Further information
The Simplified Homeopathic Registration Scheme and UK Homeopathic National Rules Scheme
Guidance on Module 3 of the homeopathic medicinal products dossier
Points to consider on stability testing of homeopathic medicinal products