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)
- Mepore is intended for use on low to moderately fluid wounds, such as surgical wounds, cuts and abrasions.
- Mepore Film & Pad is intended for use on low to moderately fluid wounds, such as surgical wounds, cuts and abrasions.
- Mepore Pro is intended for use on low to moderately fluid wounds, such as surgical wounds, cuts and abrasions.
(B)
- ARTG 205811 - Adhesive bandage
(C)
- [One or more of the following product names: Mepore / Mepore Film & Pad / Mepore Pro] can be used by lay persons under supervision of Healthcare Professionals.
- If you are concerned about your wound, please contact your Healthcare Professional
together, (the Representations).
Dated this 23rd day of October 24
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:
(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
(ii) 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