Pharmaco - InsuJet

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Pharmaco Australia Ltd

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 Pharmaco Australia Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraphs (a) and (b) below for use in advertisements directed to consumers, for the product identified in paragraph (c), provided that the conditions identified in paragraphs (d) and (e) are both met:

1. May assist people who require insulin treatment for their diabetes and would prefer not to use a needle.
2. InsuJet may not be suitable for all people with diabetes. Please seek your healthcare professional’s advice as to whether InsuJet is suitable for you.
3. InsuJet (needleless insulin injector) (Injector, medication/vaccine, needleless, mechanically-powered - ARTG No. 180917).
4. The representation set out in paragraph (a) must only be used in conjunction with the representation set out in paragraph (b)
5. The representation set out in paragraph (b) must be equally as prominent as the representation set out in paragraph (a).

Dated this 22nd day of September 2016

Signed electronically

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