Herbal Medicines

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. Currently there are three methods of bringing a herbal remedy to the UK market.

 

Unlicensed
Currently these preparations don't have to meet specific standards of quality and safety. The EU, however, is phasing out unlicensed herbals by April 2011 and all manufactured herbal medicines will have to have either a Traditional Herbal Registration (THR) or a Product Licence (PL) in order for it to continue being sold in the UK.

 

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.

 

 

By April 2011 all manufactured herbal medicines will have to be registered. In the UK, if this deadline is missed, herbal companies will not be allowed to sell their herbal medicines until their submission for a licence has been approved by the MHRA. Global Regulatory Services can help herbal companies throughout the registration process.

Please refer to our regulatory services for further information or contact us with your specific regulatory compliance requirements.