Notice of permission to use restricted representations under section 42DK of the Therapeutic Goods Act 19891
I, Dr Jane Cook, Head, Office of Product Review, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health for the purposes of section 42DK(1) of the Therapeutic Goods Act 1989, permit the use of the restricted representations described in paragraph (a) below in advertisements directed to consumers (including the label and packaging), for the goods identified in paragraph (b)2:
- Representations to the effect that the goods described in paragraph (b)3:
"may help reduce the risk of transmission of HIV/AIDS and other sexually transmitted infections (STIs)". - Natural latex rubber condoms that have been included in the Australian Register of Therapeutic Goods.
This permission revokes and substitutes the permission given by Rita MacLachlan on 18 January 2008, and published in the Commonwealth of Australia Gazette No. GN 5, 6 February 2008, permitting the use of certain restricted representations in relation to condoms.
Dated this 31 day of October 2014
Dr Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Office of Product Review
Footnotes"
- This permission takes effect on the day on which it is published in the Gazette or on TGA's website.
- This permission permits advertisers to use the restricted representations set out in this notice without contravening paragraph 42DL(1)(c) of the Therapeutic Goods Act 1989 (the Act) and section 42DM of the Act (by virtue of an alleged breach of section 5(2) of the Therapeutic Goods Advertising Code 2007). However, the advertisement in which the representations are made must otherwise comply with the advertising requirements set out in the Act and the Therapeutic Goods Advertising Code 2007.
- "Under the Medical Device Standards Order (Standards for Natural Latex Rubber Condoms) 2008, claims to the effect that "condoms can help reduce the risk of pregnancy" are also permissible.