Regulating herbal medicines in the UK and EU
What is a herbal medicine?
Herbal medicinal products are those which contain exclusively herbal substances or herbal preparations (or a combination of the two) as active ingredients.
The European directive 2001/83/EC describes a herbal substance as ‘whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh’. This definition is also closely mirrored by that of the Medicine and Healthcare productions Regulatory Agency (MHRA) who describe a herbal substance as ‘a plant or part of a plant, algae, fungi or lichen, or an unprocessed exudate of a plant’. The substance is defined by the part of the plant used, the botanical name of the plant and whether it is fresh or dried, but it is otherwise unprocessed.
These herbal substances become a herbal preparation when they are put through specific processes, which include; extraction, distillation, expression, fractionation, purification, concentration and/or fermentation.
Not all herbal products are medicines, and depending on their intended use some may be classified as food supplements or cosmetics. Those which are considered to be medicines need to undergo the correct registration procedure to enable them to be sold on the UK or EU market.
Types of application for a herbal medicine
There are 3 main routes which can be taken to market a herbal medicine within the UK or EU:
1. Stand-alone (Full) application – this route requires submission of a full dossier including non-clinical and clinical data.
- UK: Regulation 50 of The Humans Medicines Regulation 2012
- EU: Article 8 (3) of Directive 2001/83/EC
2. Traditional use registration (THR) – this requires a reduced amount of data as long as certain conditions are met surrounding historical use and indication.
- UK: Regulation 127 of The Humans Medicines Regulation 2012
- EU: Article 16a of Directive 2001/83/EC
3. Well-established use application – this pathway uses bibliographic safety and efficacy data to support the application.
- UK: Regulation 54 of The Humans Medicines Regulation 2012
- EU: Article 10a of Directive 2001/83/EC
The application route chosen will depend on the product, its indication and the available literature on the product.
What information is required for a herbal medicine?
Regardless of the application type above, a full quality dossier (Module 3 of the CTD) is required for all herbal medicinal products. This will include data on the active substance along with information on the finished product such as the manufacturing process, specifications and stability. All applications will also require full product information to be provided, including an SmPC and product labelling.
EU monographs and list entries
The European committee on herbal medicinal products (HMPC) has created ‘EU herbal monographs’ and ‘list entries’ containing therapeutic uses and indications for herbal substances and preparations.
Note: these are not to be confused with monographs of the European Pharmacopoeia which cover quality requirements for substances, including herbal substances.
These monographs and list entries can be used to support an application of a herbal medicine through the well-established use or traditional herbal registration application pathways. If an applicant can prove that a product fully complies with that of an EU list entry, no further evidence of safe and traditional use is required.
Look out for my next blog on the THR scheme, where more details will be shared on this route of application and the requirements for submission.
If you would like to discuss how Fusion Pharma can support you with herbal medicines, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
