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Abstract Detail


Society for Economic Botany/BSA Economic Botany Section

Brendler, Thomas [1].

Regulatory Legislation for Herbal Products in the European Union. A model worth adopting?

Herbal products can enter the market place in various ways and categories, ranging from herbal medicines, supplements, foods and food ingredients, all the way to cosmetics and cosmetic ingredients. These access routes are governed by national legislation which varies widely from blissful ignorance to, in the case of herbal medicines, full drug compliance. The European Union is in the process of harmonizing the regulatory framework for each of those categories in order to ensure product quality, safety and efficacy. Individual routes of access are described and discussed with regard to their relevant regulatory requirements. Focus is put on market authorizations of herbal medicines for full drug status, as bibliographic registrations for well-established use, under the framework provided in the Traditional Herbal Medicinal Products Directive (THMPD), and on food supplements in their various regulatory manifestations, specifically regarding related functional and health claims.

Broader Impacts:


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Related Links:
Plantaphile
THMPD


1 - Plantaphile, Belforter Strasse 20, Berlin, 10405, Germany

Keywords:
Herbal medicine
natural products
Regulations
European Union
Quality assurance
Traditional Herbal Medicines Directive.

Presentation Type: Oral Paper:Papers for Sections
Session: 02
Location: Maryland Room/Chase Park Plaza
Date: Monday, July 11th, 2011
Time: 9:30 AM
Number: 02007
Abstract ID:412


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