Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by Abbott Australasia Pty Ltd T/A Abbott Diabetes Care
I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, on receipt of an application from Abbott Australasia Pty Ltd T/A Abbott Diabetes Care, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertising the products identified in paragraph (B) to consumers.
(A)
- Representations referring to “diabetes” in the context of the Applicant’s trading name “Abbott Diabetes Care”
- “This product is indicated for measuring interstitial fluid glucose levels in people (aged 4 and older) with insulin-requiring diabetes”
- “For people living with diabetes” - this representation will only be used in advertisements that include the representation “this product is indicated for measuring interstitial fluid glucose levels in people (aged 4 and older) with insulin-requiring diabetes”
- "Subsidised for Australians with type 1 diabetes*" - in the body of the text and in close proximation to the restricted representation, the statement “eligibility criteria applies” will appear
together, (the Representations).
(B)
- FreeStyle Libre 2 Flash Glucose Monitoring System Sensor - Subcutaneous glucose sensor (ARTG 358292)
- Self-care monitoring web-based application software (ARTG 363331)
- Invasive interstitial-fluid glucose monitoring system (ARTG 233514)
- Information system software, application program, home healthcare (ARTG 226953)
Dated this 6th day of April 2023
Signed electronically
Michael Shum
Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch