A new European Directive (2004/24/EC) came into force on 30th April 2011 which required some of our herbal products to be registered as Traditional Herbal Medicines. This legislation is being strictly enforced in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Many of these herbal products, such as St John’s Wort, will be familiar to you but they differ in their legal classification following a change in European legislation.
In order to register a product with the MHRA as a Traditional Herbal Medicine, a pharmaceutical dossier of information is required to demonstrate that the product meets specific standards of safety and quality. This involves testing all raw materials and finished tablets for authentication, purity and stability to ensure that they comply with medicinal manufacturing standards.