A Practical Guide to Licensing Herbal Medicinal Products

A Practical Guide to Licensing Herbal Medicinal Products serves as a comprehensive and authoritative resource for pharmaceutical companies, manufacturers and regulatory professionals involved in the development and registration of herbal medicinal products. This book provides a thorough overview of the complex processes and legal requirements required to achieve compliance with the Traditional Herbal Medicinal Products Directive (THMPD) and other relevant international regulations.

Under the A Practical Guide to Licensing Herbal Medicinal Products, herbal medicines can be registered within the framework of drug law, provided that they meet strict standards of pharmaceutical quality, safety and manufacturing practices. The guide explains these requirements clearly and provides practical insight into how to prepare the documentation and evidence required for approval. In addition to registration under the THMPD, manufacturers may also consider alternative classifications, such as “well established use” marketing authorization or registration under the herbal food supplement category.

April 2009 | by Thomas Brendler