Notification of a proprietary ingredient
Form and guide
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 Proprietary Ingredients present in the therapeutic good.
Information supplied to the TGA in relation to the inclusion of Proprietary Ingredients on the ARTG is treated as 'commercial-in-confidence'. The TGA will NOT release formulation information in Proprietary Ingredients, other than in accordance with the Act or as otherwise required or permitted by law.
The Notification of a new proprietary ingredient form is the mechanism that allows Proprietary Ingredient formulations to be entered onto the ARTG. There is no assessment or evaluation of Proprietary Ingredient formulations, or their ingredients, at the time of application unless toxicological data is required to be evaluated for specific Proprietary Ingredients. During the evaluation or assessment of a finished product which contains a Proprietary Ingredient, the TGA may request additional information on the Proprietary Ingredient, given that the formulation details for a Proprietary Ingredient are supplied in isolation of the finished product formulation.
- Notification of a proprietary ingredient form (pdf,336kb)
- Guide to the completion of a 'Notification of a New Proprietary Ingredient' form (pdf,233kb)
The Notification of a new proprietary ingredient form has been recently revised (after consultation with industry). The form now consists of the following parts:
- Part (A) General Details - information about the supplier
- Part (B) Product Details - information on the intended use
- Part (C) Formulation Details
- Part (D) Additional Information - information on ingredients that may require toxicological evaluation, on ingredients derived from human/animal origin or from native/endangered species.
- Part (E) Manufacturer Details - not mandatory.
A guidance document has also been developed to assist sponsors of therapeutic goods and suppliers of Proprietary Ingredient formulations when completing the Notification of a new proprietary ingredient form (see below).
The completed form and any attachments should be sent to:
Proprietary Ingredient Coordination Unit
Non-Prescription Medicines Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
AUSTRALIA
For more information, telephone 02 6232 8465