Closing the Loop - Penfine universal click insulin pen needle and remover

Therapeutic Goods Act 1989

I, Dr Jane Cook, Acting Head, Office of Product Review, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of section 42DF(1) 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 products identified in paragraph (b) provided the conditions identified in paragraph (c) are met:

1. Representations to the effect that advertisements to consumers for the goods described in paragraph (b) may refer to: "diabetes".
2. Penfine Universal Click Insulin Pen Needle and Remover (ARTG 136221) supplied as a medical device by Closing the Loop Pty Ltd.
3. The claims made in the advertisements must not extend beyond their intended purpose on the Australian Register of Therapeutic Goods. The advertisements in which the representations are made must comply with the Therapeutic Goods Advertising Code 2007, as amended from time to time, and must advise consumers to seek advice from their medical practitioner or health care professional.

Dated this 18th day of January 2011

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