皇冠体育app

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.

皇冠体育app first dilution to be registered must be at least a 1 in 10,000 dilution of the starting material.

皇冠体育app 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鈥檛 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聽聽with the required documents through聽MHRA submissions.

You need to submit your application using the聽. If you can鈥檛 use eCTD you can use the Non-eCTD electronic Submissions (NeeS) process.

贰尘补颈濒听[email protected]聽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.

皇冠体育app 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聽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聽training webinar recording. We encourage all users to review training material before using the system.

You should use our聽eAF and cover letter tool聽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

聽(PDF,聽95 KB,聽7 pages)

Fees

Fees for the Simplified Homeopathic Registration Scheme

Fees for the UK Homeopathic National Rules Scheme

Use the聽聽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.

皇冠体育app 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.聽

皇冠体育app list includes:聽

• British Pharmacopoeia
• European Pharmacopoeia
• pharmacopoeia used officially in an EEA state

皇冠体育app above list will be updated as new entries arise.

聽(PDF,聽54.8 KB,聽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 鈥淯K Only鈥� 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

聽(PDF,聽94.8 KB,聽7 pages)

Guidance on new provisions for traditional herbal medicinal products and homeopathic medicinal products following agreement of the Windsor Framework (PDF 4 pages)

皇冠体育app Simplified Homeopathic Registration Scheme and UK Homeopathic National Rules Scheme

聽(PDF,聽131 KB,聽4 pages)

聽(PDF,聽106 KB,聽4 pages)

皇冠体育app UK Homeopathic National Rules Scheme

聽(PDF,聽160 KB,聽12 pages)

Windsor Framework

List of products assigned Category 2

Information and guidance on the main changes introduced by the Windsor Framework agreement