Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by Molnlycke Health Care Pty Ltd
I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, on receipt of an application from Molnlycke Health Care Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertisements for the product identified in paragraph (B), when the statements identified in paragraph (C) are prominently displayed or communicated[1] in the advertisement in which the restricted representations are used (including on the label and packaging of the goods).
(A)
- Mepilex Transfer Ag is intended to be used on a wide range of wounds for management of low to high amounts of wound fluid and difficult to dress wounds where there is a risk of infection such as:
- leg and foot ulcers
- pressure injuries
- partial-thickness burns and
- donor sites
(combined, the Representations).
(B)
- Mepilex Transfer Ag - Dressing, wound-nonadherent, permeable, antimicrobial (ARTG 226604).
(C)
- Mepilex Transfer Ag should be used under the supervision of a qualified Healthcare Professional.
- If you are concerned about your wound, please contact your Healthcare Professional.
Dated this 17th day of October 2024
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
[1]prominently displayed or communicated, in relation to a statement in an advertisement, means:
- either:
- for a visual statement—easily read from a reasonable viewing distance for the particular media type in the context in which the advertisement is intended to be viewed; or
- for a spoken statement—able to be clearly heard and understood; and
- repeated as often as necessary to be noticed by a viewer or listener.