Homoeopathic preparations

What are homoeopathic preparations?

"Homoeopathic preparation" is defined by the Therapeutic Goods Regulations as a preparation:

1. formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and
2. prepared according to the practices of homoeopathic pharmacy using the methods of:
   1. serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
   2. serial trituration in lactose.

Under what circumstances is a homoeopathic exempt from the need to be in the Australian Register of Therapeutic Goods (ARTG)?

Schedule 5 of the Therapeutic Goods Regulations exempts certain goods from the requirement that they must be placed on the ARTG. It refers to homoeopathic products as follows:

1. homoeopathic preparations more dilute than a one thousand fold dilution of a mother tincture and which are not required to be sterile; and which do not include an ingredient of:
   1. human origin; or
   2. animal origin, if the ingredient consists of, or is derived from, any of the following parts of cattle, sheep, goats or mule deer (detailed list follows in the regulations).

Under what circumstances is a homoeopathic exempt from the need to meet advertising requirements?

Provided that the product is not displayed or advertised to the general public (ie for use by a practitioner who is a member of a professional body in Schedule 1 of the Regulations), a homoeopathic product can carry claims which do not comply with the Therapeutic Goods Advertising Code <http://www.tga.gov.au/advert/tgac.htm> and may still be listed in the ARTG. However, the label on the container and on the primary pack must include a statement to indicate that the indications have not been "approved" by the TGA. Some homoeopathic products are exempt from GMP requirements, depending on their strength and sterility.

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