Note for guidance on specifications: Test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products

European Union guideline for herbal medicinal products

Published: TGA Internet Site: 7 April 2003

This guideline has been included for the reference of complementary medicine sponsors seeking guidance in addition to that provided in the Australian Regulatory Guidelines for Registered Complementary Medicines (ARGCM).

Where European Union (EU) guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of prescription medicines by the TGA. The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation.

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