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Demonstrating compliance with the PIC/S guide to GMP, PE009-13
This guidance is for sunscreen manufacturers who must comply with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products.
In Australia, many sunscreens are regulated as therapeutic goods because of their important role addressing public health issues. As such they must comply with the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and any other relevant regulatory requirements.
Sunscreens that are regulated as therapeutic goods under the Therapeutic Goods Act 1989 are referred to as 'therapeutic sunscreens'. Included in this category are:
- primary sunscreens with SPF 4 or more
- secondary sunscreens - except those regulated as cosmetics
- primary or secondary sunscreens with SPF 4 or more that contain an insect repellent
- sunscreens with SPF less than 4 that are exempt from being listed under the Therapeutic Goods Act 1989 because they come within the exemption in Item 8(g) of Schedule 5 of the Therapeutic Goods Regulations 1990.
Details on the therapeutic sunscreen regulatory framework are available at Australian Regulatory Guidelines for Sunscreens. To be listed on the ARTG, sunscreens must comply with the Australian and New Zealand sunscreen standard AS/NZS 2604:2012 Sunscreen products-Evaluation and classification.