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Legislation and quality control of herbal medicinal products – Regulatory aspects on phytoequivalence, pharmaceutical equivalence and bioavailability.

  • In: C5 - Quality, Safety and Efficacy of Natural Products on Sunday, 6 September 2009, 14:00-17:00
  • At: Istanbul (Turkey) (2009)
  • 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)
  • Abstract:

    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

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Last update 28 September 2023

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