Sunscreens classified as therapeutic goods are (unless exempt) required to be included in the Australian Register of Therapeutic Goods (ARTG) before they can legally be marketed in Australia.
When a company or individual (called sponsors by the TGA) want to supply a sunscreen product in Australia they must comply with the information in the Australian Regulatory Guidelines for Sunscreens. These guidelines contain information on:
- listing of therapeutic sunscreens
- registration of therapeutic sunscreens
- sunscreens which are exempt from regulation by the TGA
- responsibility of sponsors to report adverse reactions
- labelling (including a labelling checklist)
- advertisements for therapeutic sunscreens
- reproducibility of SPF test results
- stability testing
- manufacture and quality control
- permitted ingredients
- new ingredients
Sunscreens must comply with the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products - Evaluation and classification in force at the time of listing on the ARTG.
GMP for sunscreens
Sunscreens are required to be manufactured in accordance with the principles of Good Manufacturing Practice (GMP).
In 1994 primary sunscreens were classed as therapeutic goods and a Code of GMP for sunscreens was adapted from material in the medicines code. Then in 2009, the TGA rescinded the Code after consultation with industry peak bodies, and the manufacturers of primary sunscreens were required to demonstrate compliance with the harmonised Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP guide for medicinal products.
In recognition of sunscreens being a low risk topical listed product and not a prescription medicine, the TGA has developed the guidance document Sunscreen manufacturing: demonstrating compliance with the PIC/S Guide to GMP PE009-13 in consultation with a working group of industry representatives. This 2018 guidance provides a risk-based approach and focus on sunscreen products, balancing the regulatory requirements of industry with recognition of the public health issues associated with skin cancer levels in Australia. The guidance provides alternative pathways to GMP compliance for sunscreen manufacturers in key areas associated with water quality, materials sampling, raw material standards, validation activities, product quality reviews and ongoing stability trials.
What sponsors need to do
If you are a sponsor who has no previous experience with listing a therapeutic good in Australia, you may wish to seek the services of an Australian regulatory affairs consultant.
Applications to list medicines (including sunscreens) in the ARTG are completed electronically online using the Electronic Listing Facility (ELF), which is part of the TGA Business Services system. In order to access TGA Business Services and ELF, you will need to complete the TGA Business Services access forms.
Fees and charges are associated with listing or registering a product on the ARTG and for obtaining a GMP licence.
Contact information
For more information please contact the TGA information line or email: info@tga.gov.au.