Legislation and quality control of herbal medicinal products – Regulatory aspects on phytoequivalence, pharmaceutical equivalence and bioavailability.
- At: 2009 FIP Congress in Istanbul (Turkey)
- Type: Presentation
- By: KNOESS, Werner (Federal Institute for Drugs and Medical Devices, Bonn, Germany)
- Co-author(s): Reh, Klaus (Federal Institute for Drugs and Medical Devices, Bonn, Germany)
The European Union has established a common regulatory framework for (traditional) herbal medicinal products. Definitions and basic principles are laid down in Directive 2001/83 and its amendments. Specific guidance has been developed by the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency in London. Recent guidance.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.