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Overview of registered complementary medicines
ARGCM Part D: Registered complementary medicines
Registered medicines are considered to be of higher risk than listed medicines based on their ingredients and/or therapeutic indications they carry. Medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), where they:
- do not solely comprise ingredients permitted for use in listed medicines; or
- contain an ingredient or ingredient component that is subject to the conditions of a Schedule or relevant appendix to the Poisons Standard; or
- are required to be sterile; or
- have indications that are not indications permitted for use in listed medicines.
Prior to being approved for entry on the ARTG, registered medicines are subject to critical assessment by the TGA to determine whether the proposed medicine meets the requirements for quality, safety and efficacy.
Scheduling of registered complementary medicines
Registered complementary medicines may be subject to the conditions of a schedule (not Schedules 4, 8 and 9) or an appendix of the Poisons Standard, for example:
- Schedule 2 – 'Pharmacy Medicine'; or
- Schedule 3 – 'Pharmacist Medicine'.
It is important that you consider possible scheduling requirements before submitting an application for registration - refer to the Principles of Scheduling in the Poisons Standard and the AHMAC - Scheduling policy framework for medicines and chemicals. The decision to include a medicine in a schedule takes into consideration toxicity, the purpose of use, potential for abuse, safety in use and the need for the substance.
Products with similar substances and indications are likely to be subject to similar schedules. If a medicine contains a substance that requires scheduling control and it is not already scheduled, the TGA may classify the substance in one of the Poisons Standard's schedules when making the registration decision. If you are unsure of potential scheduling of your proposed medicine you should seek advice from the TGA.