Licensing Herbal Medicinal Products under the EU Traditional Herbal Medicinal Products Directive (THMPD)

Thomas Brendler, Director of Plantaphile, is a consultant and ethnobotanist with a number of phytomedicine books and publications to his credit. For the last 16 years, he has developed and managed various projects on the use of plants in medicine, food and cosmetics. His consultancy work focuses on all aspects of herbal product development, registration and licensing. In 1997 he founded PlantaPhileŽ, an innovative consultancy and image archive based in Berlin, Germany and London, UK focusing on the identification and data collection of medicinal plants and their uses in traditional medicines. He worked on the translation into English of the German Commission E monographs on medicinal plants. As a consultant to the Centre for Development of Enterprise (EU) he has been involved in the preparation and management of various CDE funded projects. In 2004 he co-founded a project on the preparation of trade standards for African medicinal plants now known as the Association of African Medicinal Plants Standards. He currently serves as director of AAMPS.

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Ann Godsell runs her own regulatory affairs consultancy to provide support and advice on all aspects required to achieve successful registration for herbal medicines in the EU. Services include advice on the appropriate route for registration of a herbal product as a medicine, and also borderline issues, including whether product may be considered under food legislation with a health claim or as a cosmetic or device. She has worked in the field of regulatory affairs for over 20 years, with further experience in the pharmaceutical industry in quality assurance, and is a Fellow of TOPRA (The Organisation for Professionals in Regulatory Affairs). Expertise in working with recent initiatives such as readability testing and Nutrition and Health Claims Regulation. Experience in all aspects of regulatory affairs in a wide range of therapeutic areas and geographical markets, with projects relating to all stages in a product lifecycle from early clinical development through to working with established brands. This experience in pharmaceuticals covers a wide number of therapeutic areas, and also a wide variety of geographical markets.

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L Denzil Phillips is Founder Director of Denzil Phillips International. He specialises in the design and implemenation of commercially orientated projects in the field of medicinal, cosmetic and aromatic plants. The company places special emphasis on the linkage between conservation and industry and the interface between industrial processors and small farmers and forest dwellers. For over 25 years we have worked with private corporations, banks and international development agencies and non government organisations in more than 30 countries. Denzil Phillips International has been retained by the EU Centre for Development of Enterprise , the UN International Trade Centre, the World Bank Group and the Commonwealth Secretariat to advise on private sector development in the field of high value natural products.

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Stefan Spiess is managing director and majority shareholder of Gruenwalder Gesundheitsprodukte GmbH, Bad Tölz, Germany. He has been active in the pharmaceutical industry for more than 20 years both as a pharmacist and food chemist. As head of regulatory control for the Hexal group he supervised more than 300 product license applications. He combines pharmaceutical, botanical and food technology expertise with regulatory and business knowledge. Besides marketing herbal products in Europe in different regulatory environments, he develops products from initial concept to formulation and regulatory affairs to market introduction. S. Spiess is a member of various professional associations. He holds patents for a number of formulations and combinations of herbal drug products. He is a consultant and advisor on certification (GMP) and a QP. His areas of expertise include pharmaceutical expert reports, product portfolios and registration strategies and advice on stability testing according to ICH and other guidelines.

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