This guidance explains TGA's interpretation and expectations for compliance by therapeutic sunscreen manufacturers, with specific sections of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13 (PIC/S Guide to GMP).
TGA has adopted the PIC/S Guide to GMP, PE009-13 (excluding Annexes 4, 5 and 14), which took effect on 1 January 2018 with a 12-month transition plan.
This guidance is not mandatory or enforceable under law. It is not intended to be restrictive. It describes a way that a sunscreen manufacturer may operate to demonstrate compliance with the PIC/S Guide to GMP, PE009-13.
This information is provided for guidance only and has been developed on the basis of current knowledge of the subject matter. It should not be relied upon to address every aspect of the relevant legislation.
In this guidance, 'we' refers to the TGA and 'you' refers to manufacturers.
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.