Roche Diabetes Care Australia Pty Ltd

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Roche Diabetes Care Australia Pty Ltd

I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraphs 1-4, for use in advertisements directed to consumers, for the products identified in paragraphs 1-4:

1.  
   • representations that refer to “diabetes” in the trading name or copyright notice of the applicant
   • “for people living with diabetes”
     in advertisements for:
     • ARTG 190251 - Clinical chemistry substrate IVDs (all Accu-Chek blood glucose strips included in this ARTG entry)
     • ARTG 167228 - Manual blood lancing device, single-use
     • ARTG 167227 - Lancet automatic
     • ARTG 100623 - Lancet automatic
     • ARTG 190250 - Instrument/analyser IVDs (all Accu-Chek blood glucose meters included in this ARTG entry)
2.  
   • “the Accu-Chek system for use with people with diabetes”
     in advertisements for:
     • ARTG 190251 - Clinical chemistry substrate IVDs (all Accu-Chek blood glucose strips included in this ARTG entry)
     • ARTG 190250 - Instrument/analyser IVDs (all Accu-Chek blood glucose meters included in this ARTG entry)
3.  
   • representations that refer to “diabetes” in the trading name or copyright notice of the applicant
   • representations that refer to “diabetes” in the product name “Roche Diabetes Care Platform”
     in advertisements for:
     • ARTG 316258 - Accu-Chek SmartPix Online - Clinical data collection/ management information application software
4.  
   • “Representations that refer to “diabetes” in the trading name or copyright notice of the applicant
   • For people living with diabetes
   • mySugr is created by people with diabetes for people with diabetes
   • Our mySugr app allows your patients to share their diabetes data with you at any time.
   • mySugr includes a digital diabetes logbook for recording blood sugar readings, which can help with the management of diabetes
   • mySugr App: your diabetes data in one place.
   • How can mySugr support my diabetes management?
   • With the mySugr app, it’s quick and easy to collect important diabetes therapy data in one place.
     in advertisements for:
     • ARTG 392894 - Self-care monitoring web-based application software (mySugr logbook)

Dated this 10th day of May 2023

Signed electronically

Michael Shum
Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch