Closing the Loop - "Timesulin" – insulin pen timer

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Closing the Loop Pty Ltd

I, Mick O'Connor, 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 Closing the Loop Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 the restricted representations described in paragraph (a)(i)-(iv) below for use in advertisements directed to consumers, for the product identified in paragraph (b):

1.  
   1. People living with diabetes can experience difficulty remembering if they have taken their insulin or not;
   2. The Timesulin smart cap displays the time since the last injection, helping those with diabetes or their carers lower the risk of missed or double doses;
   3. Did I take my insulin or not?
   4. Making life with diabetes easier.
2. "Timesulin" - insulin pen timer (ARTG No. 228962)

Dated this 30th day of September 2015

Mick O'Connor
Delegate of the Secretary to the Department of Health; and
Director
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch