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WHO guidelines on safety monitoring of herbal medicines in ...

WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems World Health Organization Geneva 2004 Contents Contents Part I WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems 1. General 2. Pharmacovigilance and the WHO International Drug monitoring What is pharmacovigilance?..9 How does pharmacovigilance operate?..10 3. Challenges in monitoring the safety of herbal Regulation, quality assurance and Appropriate 4. safety monitoring of herbal Sources of herbal products targeted for safety Reporting of suspected adverse Assessment of case Data 5. Risk 6. 7. Selected safety monitoring and Regulation of herbal medicines /traditional Quality assurance/control of herbal Rational use of herbal medicines .. 32 Annex 1: List of participants in the WHO Consultation on safety monitoring of herbal medicines , Vancouver, Canada, 1 3 February Annex 2: The Erice Declaration on Communicating Drug safety Information, 37 iii WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems Annex 3: Privacy and the confidentiality of personal health Annex 4: Spontaneous reports from persons other than health-care Annex 5: Model reporting Annex 6: Proposed database management and classification for coding herbal

herbal medicines in general rather than identifying the causes of these events, which may relate to a variety of issues. The safety of herbal medicines has ... means “safe”, and a common belief that remedies from natural origin are harmless and carry no risk. However, some medicinal plants are inherently toxic. 1 .

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