Ypsomed Australia - myLife OmniPod

Therapeutic Goods Act 1989

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

I, Simon Waters, Delegate of the Secretary to the Department of Health, on receipt of an application from Ypsomed Australia Pty Ltd, 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.  
   1. myLife OmniPod - a tubing free insulin patch pump;
   2. An Insulin Management System with just two parts for a compact solution;
   3. Integrated blood glucose meter and bolus calculator for therapy support; and
   4. The website address www.mylife-diabetescare.com.au^[1]
2. 'myLife OmniPod' (infusion pump, insulin, ambulatory – ARTG No. 169095)

3. Advertisements for the Device in which any or all of the approved representations are used must contain an advisory statement, prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance and/or heard and understood, to the effect:

   Insulin pumps may not be suitable for everyone. Please consult your diabetes educator, doctor or specialist to determine if this device is suitable for you.

Dated this 29th day of June 2017

Simon Waters
Delegate of the Secretary to the Department of Health; and
Manager, Compliance Review & Restricted Representations
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch

¹ This restricted representation is being approved solely in the context of providing the website address in consumer advertising material. The approval does not include any of the content within the website at that address.