All therapeutic goods must comply with applicable standards, which determine the consistency of product quality, before they can be entered in the Australian Register of Therapeutic Goods (ARTG).
The standards recognised under the Act are:
- The default standards, which are publicly available authoritative standards provided by the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia – National Formulary.
- Therapeutic goods orders (TGOs) made by the Minister under section 10 of the Act (TGOs)
Note that any matter specified in an order under section 10 of the Act has precedence over requirements of the default standards.
The SPF of therapeutic sunscreens must be determined by testing on human skin in accordance with the Australian Sunscreen Standard, which references the International Organisation for Standardisation procedure ISO 24444 Cosmetics – Sun Protection test methods – In vivo determination of SPF (Sun Protection Factor) as referenced in the Australian Sunscreen Standard.