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Herbal Medicines (Europe)

Herbal medicine (also known as botanical medicine, phytomedicine or phytotherapy) can be defined as "a system of medicine which uses various remedies derived from plants and plant extracts to treat disorders and maintain good health."1 They are medicines in their own right. As from 1st May 2011 the EU Herbal Directive came into full force which means that all manufactured herbal medicines placed on the European market must have either a Traditional Herbal Registration (THR) or a Product Licence (PL).  As a result of this EU Directive, there are now two key methods for herbal companies to market their herbal remedies:

Traditional Herbal Medicines Registration Scheme
This is a simplified registration scheme where herbals are required to meet specific standards of quality and safety.

Licensed Herbal Medicines
Some herbal medicines currently sold in the UK have a Product Licence in the same way as a pharmaceutical medicine. These products must demonstrate safety, quality and efficacy and be accompanied with information on safe usage.

Of course there are instances where a herbal product can be classified as a food or food with an health claim.  Please refer to our regulatory services for further information or contact us with your specific regulatory compliance requirements or to discuss the different available pathways on to the European Market.

Please note that our regulatory services section also provides outline information on the options available to botanicals and herbals at global level.

  1. Source: European Public Health Alliance