THERAPEUTIC GOODS ACT 1989
THERAPEUTIC GOODS REGULATIONS
I, Rita Maclachlan, Director, 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 section 42DF of the Therapeutic Goods Act 1989, give notice that the restricted representation described in paragraph (a) below, has been approved for use in advertisements directed to consumers, for the category of products listed in paragraph (b) provided the conditions identified in paragraph (c) are met:
- Representations to the effect that use of the goods described in paragraph (b) below:
- "asthma"
- DelvTech Sports-Halers
- The advertisements for these devices must comply with the general provisions about advertising therapeutic goods in Chapter 5, Division 3 of the Therapeutic Goods Act 1989 including the Therapeutic Goods Advertising Code,
- The references to restricted representations are consistent with the manufacturer's intended purpose and recorded on the Australian Register of Therapeutic Goods and current clinical evidence;
- The advertisements for these devices must be qualified to ensure there is no statement or implication that these devices are suitable for all asthmatics; and
- The advertisement for this device must be accompanied by a statement advising consumers to seek advice from their pharmacist as to which medications are suitable for use with this device.
Dated this 7th day of April 2008.
RITA MACLACHLAN
Delegate of the Secretary to the Department of Health and Ageing