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Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by PainChek Ltd
I, Rowena Love, as a delegate of the Secretary to the Department of Health and Aged Care, on receipt of an application from PainChek Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representation described in paragraph (A), for use in advertisements for the product identified in paragraph (B) subject to the conditions identified in paragraph (C).
(A)
- ‘PainChek is an observational pain assessment tool to assist healthcare professionals and carers in assessing and monitoring pain in residential aged care and other healthcare settings for people living with dementia and other communication disorders who are unable to self-report their pain’.
(B)
- PainChek – Adult – Information system software, application program (ARTG 302794)
(C)
- Advertisements in which the approved restricted representation is used must comply with the Therapeutic Goods Advertising Code.
Dated this 5th day of March 25
Signed electronically
Rowena Love
Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch