The UK Medicines and Healthcare products Regulatory Agency (MHRA) has given a deadline of 30 April 2014 for all manufactured herbal medicines to comply with the EU traditional herbal medicinal products legislation (Directive 2004/24/EC).
This means that after this date, UK retailers of herbal remedies will no longer be able to sell such products unless they are registered under the Traditional Herbal Registration (THR) scheme or have a full marketing authorisation.
Products registered under the THR scheme meet safety and quality standards and are accompanied by patient information about the product and how it should be used. Registered products can be identified by the THR logo and a THR number on their label.
The Traditional Herbal Medicinal Products Directive
Directive 2004/24/EU, or the European Traditional Herbal Medicinal Products Directive (THMPD), came into effect on 30 April 2011. It establishes a regulatory approval process for herbal medicines in the EU and 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.
UK transitional period longer than expected
For herbal medicines that were on the UK market before April 2011, the MHRA allowed retailers to “sell through” their stock because it was anticipated that they would be sold within an 18-24 month period – the average shelf-life of these products. This transitional protection also allowed manufacturers to bring their production up to the required standards to comply with the directive.
However, these unlicensed herbal medicines are still being sold and in July 2013, the MHRA launched a consultation to seek views about ending the sell-through period. The responses have now been considered and 30 April 2014 is the deadline for retailers to stop selling these products.
See the MHRA website for more information and guidance on determining whether your product is subject to these rules.