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Australian regulatory guidelines for sunscreens (ARGS)

Version 1.2

30 August 2019

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This guideline is currently under review.

The Australian regulatory guidelines for sunscreens (ARGS) have been developed to provide guidance to sponsors and manufacturers, and to assist in the understanding of the regulatory requirements for sunscreens in Australia.

The Australian regulatory guidelines for sunscreens includes information about:

  • the different types of sunscreens
  • which regulatory organisation regulates which type of sunscreen:
    • TGA
    • National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and Australian Competition and Consumer Commission (ACCC)
  • the differences between the 2012 sunscreen Standard AS/NZS 2604:2012 and the 1998 Standard
  • when therapeutic sunscreens are allowed to comply with the 1998 Standard, and when they need to comply with the 2012 Standard
  • other regulatory requirements for sunscreens regulated by the TGA.

The TGA developed these guidelines in consultation with NICNAS, Accord Australasia, Australian Self-Medication Industry Inc (ASMI) and the Advisory Committee on Non-prescription Medicines (ACNM). A public consultation was also conducted.

The ARGS replaces Chapter 10 'Sunscreens' in the Australian regulatory guidelines for OTC medicines (ARGOM).

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