Application for selective non-disclosure of active herbal extract details
Form and guide
- Application for selective non-disclosure of active herbal extract details form (pdf,152kb)
- Guide to the completion of an 'Application for selective non-disclosure of active herbal extract details' form (pdf,98kb)
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 Registered / Listed on the ARTG, the formulation of the therapeutic good must be supplied to the Therapeutic Goods Administration (TGA). This includes the formulation details of Active Herbal Extracts present in the therapeutic good.
The 'Application for Selective Non-Disclosure of Active Herbal Extract Details' form is the mechanism that allows confidential Active Herbal Extract details to be entered onto the ARTG, following an assessment process by the TGA Laboratories to ensure that the herbal ingredient and manufacturing process comply with the definition of a herbal substance (as defined in Regulation 2 of the Therapeutic Goods Regulations 1990). A successful application will result in selective details relating to an Active Herbal Extract (eg. solvent type, concentration extract ratio and extract excipient details) being kept confidential from the sponsor.
Information supplied to the TGA in relation to the inclusion of an Active Herbal Extract on the ARTG is treated as 'commercial-in-confidence'. However, suppliers should be aware that once an application for selective non-disclosure of Active Herbal Extract details has been approved by the TGA, some information about the Active Herbal Extract (such as herb species, plant part and ratio of equivalent dry weight to extract amount) may not be confidential from the sponsor. More details about the information available to third parties is included in the Guide to the Completion of the 'Application for Selective Non-Disclosure of Active Herbal Extract Details' form.
The Application for Selective Non-Disclosure of Active Herbal Extract Details form consists of the following parts:
- Part (A) General Details - information about the supplier
- Part (B) Product / Formulation Details - information on the composition of the Active Herbal Extract
- Part (C) Information Regarding Ingredients of Human or Animal Origin
A guidance document has also been developed to assist sponsors of therapeutic goods and suppliers of Active Herbal Extract formulations when completing the 'Application for Selective Non-Disclosure of Active Herbal Extract Details' form.
The completed form and any attachments should be sent to:
For more information, telephone 02 6232 8288