Traditional Herbal Medicines – A simplified Way of Registering Herbal Medicines in the European Union? A Review

Licensing of herbal medicinal products in the European Union is changing. By 2011, every pharmaceutical company manufacturing herbal medicines that are marketed in the European Union must have obtained a market authorization.

The Traditional Herbal Medicinal Product Directive 2004/24/EC (THMPD) was established in 2005. It has since been implemented in most EU member states and been supplemented with many other EU guidelines relevant to the field of herbal medicines. It allows herbal products to be registered under medicines law. While THMPD provides a major market opportunity for manufacturers of quality herbal medicinal products suitable for registration under this scheme from all over the world, many still find it very difficult to work through the practical steps required to register a product as a traditional herbal medicinal product (THMP) in the EU.

This presentation reviews the regulations and their practical implementation with specific focus on the UK market. It highlights requirements for the registration application documentations, specifically product classification, quality, safety and proof of traditional use; covers the European Medicines Agency (EMEA) efforts of compiling community monographs as a basis for traditional and well-established-use registration applications, and presents the application procedure, looks at licenses granted, general issues and areas of concern encountered with license applications being processed.