Confidential Pathology - Vaginal self‐sampling kit

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Confidential Pathology

I, Leanne McCauley, Director, Advertising Compliance Unit, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Confidential Pathology, 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 condition identified in paragraph (c) is met:

1. Once we receive your sample, we test it for the balance between 'good' bacteria (Lactobacillus crispatus and Lactobacillus iners) and 'undesirable' bacteria (Gardnerella vaginalis, Atopobium vaginae) that can cause bacterial vaginosis.
2. Vaginal self‐sampling kit (ARTG 235564)

3. A statement to the effect:

   "You should see your healthcare provider as soon as possible if:

   • You consider that you may be at risk of an STI;
   • Your symptoms have persisted for some time or have recurred, or your condition has worsened, as these symptoms may be indicative another infection, including an STI;
   • or
   • You are pregnant."

must appear whenever the restricted representation in paragraph (a) is used, irrespective of the type of advertisement.

Dated this 16th day of May 2018

Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Director
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch