Supply of clindamycin [as phosphate] 1% and benzoyl peroxide 5% (Duac Once Daily Gel) 6 g topical gel tubes by GlaxoSmithKline Australia Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On October 22 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:

(a)   the supply of the product clindamycin [as phosphate] 1% and benzoyl peroxide 5% (Duac Once Daily Gel) 6 g topical gel tubes [Aust R 100707] by GlaxoSmithKline Australia Pty Ltd, Melbourne VIC (“the Company”):

That does not conform with paragraph 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the details of the previous sponsor are listed on the tube labels, instead of the details of the Company.

Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:

1. The consent applies for batch 242P of the product with the expiry date March 2014 (approximately 2046 units, each containing 10 tubes, which have not yet been supplied, as detailed in correspondence from the Company dated October 11 2012).
2. The tube labels to which this consent applies are identical to those supplied with correspondence from the Company dated August 29 2012, which have the previous sponsor details.
3. No other changes have been made to the product clindamycin [as phosphate] 1% and benzoyl peroxide 5% (Duac Once Daily Gel) 6 g topical gel tubes [Aust R 100707].
4. Any correspondence from customers addressed to the previous sponsor will be promptly redirected to the Company.
5. Future batches of the product clindamycin [as phosphate] 1% and benzoyl peroxide 5% (Duac Once Daily Gel) 6 g topical gel tubes [Aust R 100707] will be in full conformance with the requirements of TGO 69.