Visiomed Group and Infamed - Breath-a-tech spacer & funhaler

Published in the Commonwealth of Australia Gazette, No GN 40, 8 October 2008

THERAPEUTIC GOODS ACT 1989

I, SHELLEY TANG, Acting Head, Office of Devices, Blood and Tissues, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of subsection 42DK(1) of the Therapeutic Goods Act 1989 give notice that the restricted representations described in paragraph (a) below, have been approved for use in advertisements directed to consumers, for the goods listed in paragraph (b) provided the conditions identified in paragraph (c) are met:

1. Representations to the effect that the goods described in paragraph (b) are used:
   • "Effective delivery of Asthma medication"
   • "Breath-a-Tech: helping you manage your Asthma"
   • "The Funhaler may assist in the delivery of asthma medication"
2. Visiomed Group Limited and Infamed Ltd's Breath-a-Tech Spacer
   Visiomed Group Limited and Infamed Ltd's Funhaler
3.  
   1. The advertisement in which the representation is made must comply with the Therapeutic Goods Advertising Code as defined in subsection 3(1) of the Therapeutic Goods Act 1989; and
   2. Must advise consumers to seek advice from their medical practitioner; and
   3. Not use the word "Asthma" in its adjectival form to describe the devices listed in paragraph (b).

Dated this 12th day of September 2008

SHELLEY TANG
Delegate of the Secretary to the Department of Health and Ageing