Schedule 14 to the Regulations provides a list of designated active ingredients for complementary medicines. If a substance is of the type listed in Schedule 14 to the Regulations, it may be eligible for evaluation for use in listed complementary medicines providing:

• the substance is not a prohibited import
• where the substance is of herbal origin, it is not subject to a restriction the substance or its constituent/s, is/are not subject to the conditions of a Schedule (or applicable Appendix) to the Poisons Standard

Some substances are subject to the conditions of a Schedule (or applicable Appendix) to the Poisons Standard only if present in a certain quantity in a finished product. Accordingly, appropriate restrictions (for example: dose, route of administration) must be placed on the use of such an ingredient in listed medicines.

If the proposed new substance is not currently in a Schedule to the Poisons Standard but the substance, or its constituent, has a potential safety concern that may meet the criteria for inclusion in a Schedule, you should seek advice from the TGA prior to submitting an application. Should it be identified during the course of the evaluation that the substance meets the criteria for inclusion in a Schedule, the matter will be referred to the relevant scheduling advisory committee. It may be determined that the substance is not suitable for use in listed medicines on the basis of the scheduling decision.

If you consider the scheduling of a substance should be reconsidered, you can submit an Application to amend the Poisons Standard.