HERBAL MEDICINES
Herbal Medicines
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.
At Fusion Pharma we understand navigating the field of herbal medicines can be a challenging experience, however correctly categorising your product is the first step of a successful application.
Our blogs go into further details on the different types of applications available. Should you need any support in any of the service areas listed below, please do not hesitate to contact us.
Fusion Pharma is a member of the British Herbal Medicine Association.
Services we offer:
- Categorisation for borderline products
- Submission strategy
- Traditional herbal registrations (THR)
- Writing Marketing Authorisation Applications
- Lifecycle management
