BD insulin syringes

Published in the Commonwealth of Australia Gazette No. GN 30, 3 August 2005

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:

1. Representations to the effect that use of the goods described in paragraph (b) below:
   "diabetes"
2. BD Micro-Fine Pen Needles
   BD Ultra Fine Insulin Needles
   BD Safety Lok Insulin Syringes
   BD Lancet Device
   BD Micro-Fine Lancet
   BD MAGNI-Guide
   BD Inject-Ease Automatic Injector
3. The goods must first be included in the Australian Register of Therapeutic Goods (ARTG). The claims made in the advertisements must not extend beyond their intended purpose on the ARTG. The advertisements in which the representations are made must comply with the Therapeutic Goods Advertising Code and must advise consumers to seek advice from their medical practitioner/ health care professional.

Dated this 9th day of July 2005

RITA MACLACHLAN
Delegate of the Secretary to the Department of Health and Ageing