GovWire

1. Overview

This guidance describes how registrations for traditional herbal medicines and homeopathic medicines will be handled by the Medicines and Healthcare products Regulatory Agency (MHRA)?following agreement of the Windsor Framework.

2. Traditional herbal medicines (THR)

According to the Human Medicines Regulations (2012), a product is a herbal medicinal product if the active ingredients are herbal substances and/or herbal preparations only.

In certain circumstances vitamins and minerals may be added to the product provided that their action is ancillary to that of the herbal active ingredients regarding the specific claimed indication(s).

For further information about the definition of a herbal medicinal product and how to apply for a registration for a traditional herbal medicinal product, see Guidance: Apply for a traditional herbal registration (THR).

New arrangements for human medicines come into effect from 1 January 2025 reflecting the agreement on human medicines as part of the Windsor Framework. However, registration of traditional herbal medicines falls outside the scope of the Windsor Framework and is therefore not impacted. This means that the provisions introduced from 1 January 2021 when the UK left the EU still apply, as follows.

In relation to traditional herbal medicines registered and marketed only in Great Britain (that is, those with the prefix THR GB), the Human Medicines Regulations 2012 (as amended) has the provision to accept 15 years of traditional use evidence from a wider range of countries in addition to EU/EEA countries, provided they have a level of pharmacovigilance equivalent to that of the UK. This is to ensure that any safety issues have been properly identified to support the traditional use of the product. Therefore, the MHRA may expand the list of countries from which it accepts traditional use evidence.If this provision is used, the MHRA will publish a list of suitable countries for this purpose which will be updated as new entries arise.

The MHRA may also publish its own list of herbal substances, preparations and combinations for use in traditional herbal medicines. This will include the entries in the existing EU List and the MHRA list will be updated as new entries arise.

These provisions above do not apply to traditional herbal medicines intended to be marketed in Northern Ireland. Therefore, they do not apply to UK-wide registrations for traditional herbal medicines or those registrations for Northern Ireland only.

In those cases:

• traditional use evidence should be provided that the product or a corresponding product has been used for a period of 15 years in the EU/EEA

• only the EU List will be applicable for applicants wanting to apply to market a UK-wide traditional herbal medicine

3. Homeopathic medicines

Information on how to register a homeopathic medicine is available in the document, Register a homeopathic medicine.

The Windsor Framework in relation to medicinal products will be implemented from 1 January 2025. However, homoeopathic medicines registered under the simplified registration scheme fall outside the scope of the framework and are therefore not impacted.

This means that the provisions introduced for homoeopathic medicines registered under the simplified registration scheme from 1 January 2021 when the UK left the EU still apply as stated in section 3.1 below.

However, homeopathic medicines authorised through the National Rules scheme are within scope (refer to section 3.2 below).For further details, refer to guidance on UK-wide licensing of medicines.

3.1 Simplified registration scheme

The definition of a homeopathic medicinal product is stated in Regulation 8 of the Human Medicines Regulations 2012 (as amended).

For applications for a certificate of registration for Great Britain only (those with the prefix HR GB), the definition covers products 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.

The list includes:

• British Pharmacopoeia

• European Pharmacopoeia

• pharmacopoeia used officially in an EEA state

The above list will be updated as new entries arise.

The definition does not apply to applications covering Northern Ireland, therefore it does not apply to applications for a UK-wide homeopathic registration or to applications for homeopathic registrations for Northern Ireland only.In those cases,the EU meaning of a homeopathic medicinal product will apply which is as follows.

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.

3.2 Homoeopathic National Rules

Products authorised through marketing authorisations under the Homoeopathic National Rules scheme are covered by the Windsor Framework.From 1 January 2025 the MHRA will only authorise products through National Rules on a UK-wide basis. These products are likely to be category 2 under the Windsor Framework. Refer to this separate guidance on National Rules and guidance on UK-wide licensing.

4. Contact

For further information, contact our Customer Services Centre at?RIS.NA@mhra.gov.uk or telephone 020 3080 600.?