Supply of tretinoin (STIEVA-A 0.1%) 1 mg/g cream tube by GlaxoSmithKline Australia Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On October 25 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 tretinoin (STIEVA-A 0.1%) 1 mg/g cream tube [Aust R 39838] 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 sponsor details on the carton and tube labels are those of the previous sponsor Stiefel, instead 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 to supply applies until the end of February 2013, for the 25 g pack size only.
2. The labels to which the consent applies are identical to those supplied by the Company in correspondence dated August 24 2012, which have the previous sponsor details (those of Stiefel).
3. No other changes have been made to the product tretinoin (STIEVA-A 0.1%) 1 mg/g cream tube [Aust R 39838] except for the differences in labels.
4. Any correspondence from customers addressed to the previous sponsor will be promptly redirected to the Company.
5. Future batches of the product tretinoin (STIEVA-A 0.1%) 1 mg/g cream tube [Aust R 39838] will be in full conformance with the requirements of TGO 69.