Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by Medical Developments International Limited
I, Robert W Hignett, Delegate of the Secretary to the Department of Health, on receipt of an application from Medical Developments International Limited, 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):
- Representations to the effect that the good described in paragraph (b) is:
- 'designed to improve the delivery of asthma and COPD medication to the small airways deep within the lungs'
- 'a compact spacer for use with most standard puffers in the treatment of asthma and COPD'
- 'Breath-A-Tech Spacer' (medicine chamber spacer - ARTG No. 142303)
Dated this 16 day of January 2017
Robert W Hignett
Delegate of the Secretary to the Department of Health; and
Manager, Compliance Review & Restricted Representations
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch