Guidance on new provisions for traditional herbal medicinal products and homeopathic medicinal products
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
Traditional herbal medicines
For issues relating to place of establishment, variations and other regulatory issues which would previously have been regulated at EU-level, please refer to guidance on marketing authorisations (MAs)
From 1 January 2021, the MHRA may expand the list of countries from which it accepts evidence for traditional herbal medicines. Prior to 1 January 2021 evidence for traditional herbal registration had to be provided that the product or a corresponding product had been used for a period of 15 years within the EU/EEA.
From 1 January 2021, the MHRA may be able to accept the 15 years of traditional evidence from a wider range of countries in addition to EU/EEA countries. Suitable countries will be those that 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. The MHRA will publish a list of suitable countries for this purpose which will be updated as new entries arise.
This provision does not apply to traditional herbal medicines intended to be marketed in Northern Ireland. For these products, traditional use evidence should be provided that the product or a corresponding product has been used for a period of 15 years within the EU/EEA. The MHRA may 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.
Only the EU list will be relevant for applicants wanting to apply to market a traditional herbal medicine in Northern Ireland.
Homeopathic medicines
For issues relating to place of establishment, variations and other regulatory issues which would previously have been regulated at EU-level, please refer to guidance on marketing authorisations (MAs).
From 1 January 2021, the definition of a homeopathic medicinal product has been expanded. 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.
This provision will not apply to products marketed in Northern Ireland and the current EU definition of a homeopathic medicinal product will remain.
This guidance is in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2020.
Contact
For further information, please email our Customer Services Centre at RIS.NA@mhra.gov.uk. Alternatively, contact your Trade Association by emailing:
- Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk
- British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk
- BioIndustry Association (BIA): regulatory@bioindustry.org
- Clinical & Contract Research Association (CCRA): mail@ccra.org.uk
- Ethical Medicines Industry Group (EMIG): info@emig.org.uk
- Health Food Manufacturers’ Association (HFMA): pennyviner@btconnect.com
- The National Pharmacy Association (NPA): independentsvoice@npa.co.uk
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Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk