Bayer Australia - Citrical

Therapeutic Goods Act 1989

I, Jane Cook, Head, Office of Product Review, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Bayer Australia 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), provided the condition identified in paragraph (c) is met:

1. Representations to the effect "may assist in preventing osteoporosis".
2. CITRICAL Calcium Citrate (AUSTL 131240) and CITRACAL Plus D (AUSTL 129696).
3. The representations identified in paragraph (a) above must only be used in conjunction with the phrase to the effect: "when dietary calcium intake is inadequate".

Dated this 1 day of September 2014

Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Office of Product Review