A practical guide to licensing herbal medicines products

The procedure for licensing herbal products in the UK and European Union is changing. The Traditional Herbal Medicinal Product Directive (THMPD) was implemented in the UK in 2005 and allows herbal products to be registered under medicines law. By 2011, every pharmaceutical company manufacturing herbal medicines that are sold in the UK and European Union must have obtained a market authorization.
The THMPD allows herbal products to be registered under medicines law. To gain this registration, these products must demonstrate high (pharmaceutical) standards of manufacture and product quality. Other options for manufacturers are to gain a marketing authorization category for a product called “well-established use” or to register their product under the category of a herbal food supplement. The law therefore establishes a means for companies to decide within which category to market their products. The decision depends, to some extent, on the amount of data available or the level of claim they wish to make. This guide is intended to be used as a manual/workbook to give practice help and instructions on accomplishing these tasks. The guide includes all available information and documents in the entire registration procedure from initial decision making through to receiving a license or rejection.

Part 1. Product Eligibility: Classification of Herbal (medicinal) Products: Part 2. Content and Presentation: Proof of Tradition: Common Technical Document: Good Agricultural and Collection Practice: Quality Requirements for Traditional Herbal Medicinal Products: Safety and Pharmacovigilance: Labelling: Part 3. The Practicalities: Submission of THM Registration Applications-frequently Asked Questions: Part 4. Appendices.