The European market has harmonized regulations for the marketing of herbal medicinal products and issued the Traditional Herbal Medicinal Products Directive (THMPD). It came into force on 30 October 2005 and requires traditional, over-the-counter herbal remedies to be made to assured standards of safety and quality and in conformity with regulations so that these are standardized across Europe. According to the directive no herbal medicinal product shall be allowed in the European Union (EU) market without a licence since its implementation and it intended a simplified registration procedure with a seven-year transition period for traditional herbal medicinal products to obtain a medicine licence.

The EU directive thus allows the licensing and over-the-counter sale of herbal products that have a history of use anywhere in the world for at least 30 years, 15 of which must be in an EU member state. The European Medicines Evaluation Agency (EMEA) issued Guidelines on Specifications, Test Procedures and Acceptance, Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products in 2005 to ensure the quality of the starting plant material, development, in-process controls, GMP controls and process controls, and by specifications applicable to them throughout development and manufacture.

According to the THMP Regulations 2005, no traditional herbal medicinal products shall be placed on the market or distributed wholesale, unless a traditional herbal registration has been obtained in accordance with the relevant community provisions by the licensing authority.