SECTion 14 AND 14A NOTICE
I, Mayada Kayali, delegate of the Secretary to the Department of Health and Ageing for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (‘the Act’) hereby give my consent, pursuant to sections 14 and 14A of the Act, for GlaxoSmithKline Pty Ltd, Level 3 of 426 Johnston Street, Abbotsford VIC 3067, to supply OILATUM Plus Concentrated Bath Emollient (AUST R 14540) that does not comply with Clause 3(2)(l) of Therapeutic Goods Order No. 69 in that the label does not include the name and address of the currently approved sponsor or supplier of the goods.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The label includes the name and address of the previously approved sponsor or supplier of the goods being Stiefel Laboratories Pty Ltd, Unit 2/10 Salisbury Road, Castle Hill NSW 2154 as per the previously approved label, approved by the TGA on 8 May 2000
2. This exemption is restricted to only the following two batches of the product: F1546 and F1547
3. The current sponsor will continue arrangements where the contact details provided on the label for the previous sponsor will direct the consumer to the current sponsor
4. The product complies with all other aspects of the standard
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
26 November 2012