This section of the site is aimed at anyone wishing to place herbal medicines on the UK market and outlines the different regulatory requirements.
The new European Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC came into effect on 30 April 2011. The Directive establishes a regulatory approval process for herbal medicines in the European Union (EU). It requires each EU Member State to set up a traditional herbal registration scheme for manufactured traditional herbal medicines that are suitable for use without medical supervision.
Companies are no longer able to sell manufactured unlicensed herbal medicines unless they have an appropriate product licence, either:
Traditional Herbal Medicines Registration Scheme
Prohibited or restricted herbal ingredients
Is your herbal product a medicine?
Marketing authorisations for herbal medicines
Around 500 herbal medicines hold a marketing authorisation (a product licence). To get a marketing authorisation a product needs to meet standards of safety, quality and efficacy (or effectiveness).
When seeking a licence for herbal medicines, many companies have had difficulty meeting conventional requirements to prove efficacy. This was one factor that led to the introduction of the Traditional Herbal Registration Scheme and many products are likely to follow that regulatory route.
However, it will continue to be possible to obtain a marketing authorisation for herbal medicines where the required levels of efficacy as well as safety and quality can be demonstrated.