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Guidelines on the evidence required to support indications for listed complementary medicines
Appendix 3: Examples of internationally recognised resources and texts - monographs and pharmacopoeias
The TGA does not review the information included in internationally recognised resources and texts for example – monographs, pharmacopoeias, other text publications. It is your responsibility to ensure that the evidence you provide to support your indications is relevant to your medicine and is of sufficient quality.
The texts that are listed in this appendix are examples of internationally recognised texts that may provide evidentiary support to your indications.
- Blumenthal M et al. (eds) (2000) Herbal Medicine – Expanded Commission E monographs, American Botanical Council, Austin, Texas.
- European Scientific Co-operative on Phytotherapy (ESCOP) series (1996) Monographs on the Medicinal Uses of Plant Drugs, ESCOP, Exeter.
- World Health Organization (WHO) (1999) Monographs on Selected Medicinal Plants, Vol 1, WHO, Geneva.
- British Herbal Pharmacopoeia, British Herbal Medicines Association, West Yorkshire.
- European Pharmacopoeia, Council of Europe, Strasbourg.
- Martindale: the Extra Pharmacopoeia, Pharmaceutical Press, London.
- The British Pharmaceutical Codex, Pharmaceutical Press, London.
- The British Pharmacopoeia, Her Majesty's Stationery Office, London.
- The United States Pharmacopeia and National Formulary, USP Convention Inc, Rockville, Maryland.
- Pharmacopoeia of the People's Republic of China Vol 1