This guidance is for sunscreen manufacturers who must comply with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, namely manufacturers of sunscreen products that are regulated as therapeutic goods by the TGA.
Details on the therapeutic sunscreen regulatory framework are available at Australian Regulatory Guidelines for Sunscreens (ARGS). Therapeutic sunscreens must comply with the Australian/New Zealand Sunscreen Standard currently adopted by the TGA.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.