Ansell - Dual Protect Condom

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Ansell Ltd T/A Ansell Healthcare

I, Jane Cook, Head, Post-market Surveillance Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Ansell Ltd T/A Ansell Healthcare, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the conditions identified in paragraph (c) are met:

1.  
   1. VivaGel^® is an anti-viral agent proven, in laboratory studies only, to inactivate HIV, herpes simplex virus (HSV) and human papillomavirus (HPV), which are viruses that cause sexually transmitted infections (STIs); and
   2. The physical barrier of the condom provides primary protection against sexually transmitted infections (STIs)
2. 'Dual Protect Condom' (ARTG No. 228796)
3.  
   1. Representations to the effect of that set out in paragraph (a)(i) must only be used in conjunction with representations to the effect of that set out in paragraph a(ii).
   2. (ii) A representation to the effect of that set out in paragraph a(ii) must be at least as prominent as the representation in paragraph 1(a).

Dated this 11 day of May 2015

Dr Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Post-market Surveillance Branch