Compositional guideline template

22 July 2014

A compositional guideline is a summary of descriptions, tests and limits that define the composition and characteristics of a substance approved for use in listed medicines as either an active substance or an excipient. Compositional guidelines are required where there is no standard for the substance in any of the default standards identified in the Therapeutic Goods Act 1989 (i.e. the British Pharmacopoeia, United States Pharmacopoeia or the European Pharmacopoeia).

This template is for prospective sponsors and substance manufacturers to supply with their applications as described in the Australian Regulatory Guidelines for Complementary Medicines, Part 3, section 4.4.

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