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On October 16, 2018, Australia’s Department of Health has released a guidance document regarding sunscreen manufacturing.

This guidance explains TGA’s (Therapeutic Goods Administration) 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.

Sunscreens must comply with the Australian and New Zealand sunscreen standard AS/NZS 2604:2012 Sunscreen Products-Evaluation and classification to be listed on the Australian Register of Therapeutic Goods (ARTG).



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