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Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by ENT Technologies Pty Ltd
I, Rowena Love, as a delegate of the Secretary to the Department of Health, on receipt of an application from ENT Technologies Pty Ltd have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (A) below for use in consumer advertising of the products identified in paragraph (B):
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- Suitable for asthma patients (the Suitability Statement)
- If you have asthma, please check with your health professional that this product is right for you (the Advisory Statement) with the Advisory Statement prominently displayed or communicated adjacent, or in close proximity to, the Suitability Statement, whenever the Suitability Statement is used in consumer advertising.
- Flo proudly supports the work of Asthma Australia (or words of similar effect).
- Products marketed as "Flo" under the following entries in the Australian Register of Therapeutic Goods:
- Irrigation fluid, nasal (ARTG Numbers 150556, 150542 and 300343); and
- Irrigation kit, nasal (ARTG Number 210030).
Dated this 12th day of March 2021
Signed electronically
Rowena Love
Delegate of the Secretary to the Department of Health
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch