A Regulatory Overview of Sunscreens in Australia
An extensive sun protection strategy must include sunscreen.They must be both safe and effective, as well as of high quality. As a result, the Therapeutic Goods Administration regulates sunscreens in Australia under the Therapeutic Goods Act 1989. The Australian Regulatory Guidelines for Sunscreens (ARGS) lay out the regulatory requirements and standards for sunscreens and their ingredients in Australia. The ARGS refers to sunscreens regulated under the Act as therapeutic sunscreens.
Therapeutic sunscreens are divided into the following categories:
• Primary Sunscreens – These are products that are primarily used to protect against UV rays.
• Some Secondary Sunscreens – Products that have a main purpose other than sun protection but contain sun-screening ingredients, such as moisturisers with SPF greater than 15.
Sunscreen manufacturers are only allowed to use approved compounds, which have all been tested for safety. Before therapeutic sunscreens to be lawfully marketed in Australia, they must be listed in the Australian Register of Therapeutic Goods (ARTG). Manufacturers must have the following in order to market sunscreen in Australia:
• a submission to the ARTG for that medicinal sunscreen;
The Sun Protection Factor (SPF) listed on the label must be determined by testing the efficacy of each product, according to the TGA. According to the current Labeling Order and Advertising Code, sunscreen labels may include brand logos, emblems, and consumer information. Therapeutic sunscreen advertising and labeling must adhere to the following guidelines:
• the most up-to-date version of the Advertising Code
• the most recent edition of the Labeling Order
• the Australian Standard for Sunscreens
In a nutshell, therapeutic sunscreen manufacturers must meet the TGA ARGS criteria in order to enter the Australian market. A flexible alternative for hassle-free market launch of sunscreens in Australia is to work with a regulatory specialist. Call Maven right now!
Category: Pharmaceuticals, Cosmetics Regulatory Services, Regulatory Affairs
Key Words: Sunscreens, Therapeutic Sunscreens, TGA, ARGS, ARTG, Therapeutic Goods, Australia
Leave A Comment