Notification of selective non-disclosure of Active Herbal Extract details

23 June 2015

Read the Guide to the completion of the 'Notification of selective non-disclosure of Active Herbal Extract details' form before completing the form.

The Therapeutic Goods Act 1989 requires that therapeutic goods supplied in Australia, unless specifically exempted or excluded, be registered or listed on the Australian Register of Therapeutic Goods (ARTG), before they can be supplied in, or exported from, Australia.

Before a therapeutic good can be entered on the ARTG, the formulation of the goods must be supplied to the Therapeutic Goods Administration (TGA). This includes the formulation details of Active Herbal Extracts present in the goods.

'Notification of selective non-disclosure of Active Herbal Extract details' form should be used to request the TGA to keep certain details regarding an 'Active Herbal Extract' (e.g. solvent type, concentration extract ratio and extract excipient details) confidential from sponsors of therapeutic goods. Please note that information such as herb species, plant part, basic preparation details (e.g. concentrated extract), ratio of equivalent dry weight to extract amount, and component percentage (if relevant) may not be confidential from the sponsor.

For more information, telephone +61 2 6232 8634 or email complementary.medicines@tga.gov.au.

Notification of selective non-disclosure of Active Herbal Extract details form

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