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Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by Molnlycke Health Care Pty Ltd
I, Rowena Love, as a delegate of the Secretary to the Department of Health, Disability and Ageing, 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 in advertisements in which the restricted representations are used.
(A)
Mepilex Border Ag is intended to be used on infected wounds or wounds at risk of infection with medium to high amounts of wound fluid, such as:
- leg and foot ulcers
- pressure injuries
- partial-thickness burns
- traumatic and surgical wounds.
(B)
Mepilex Border Ag - Wound-nonadherent dressing, absorbent, antimicrobial (ARTG 184669)
(C)
- Mepilex Border 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 11th day of June 2026
Signed electronically
Rowena Love
Delegate of the Secretary to the Department of Health, Disability and Ageing
Education Policy and Guidance Section
Regulatory Compliance Branch
1prominently displayed or communicated, in relation to a statement in an advertisement, means:
(a)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
(b) repeated as often as necessary to be noticed by a viewer or listener