Supply of products by Merck Sharp & Dohme (Australia) Pty Limited

Therapeutic Goods Act 1989

SECTION 14, 14A AND 15 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 Merck Sharp & Dohme (Australia) Pty Limited to supply specific batches of the medicines listed at Attachment 1 which do not comply with subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines such that  the labels do not include the name and address of the current sponsor.

Pursuant to section 15(1) of the Act, my consent is subject to the following condition:

1. The consent applies to the batches listed at Attachment 1 only;
2. The medicine complies with all other aspects of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines;
3. The medicine labels include the name and address of the previous sponsor Schering-Plough Pty Ltd, and 
4. Merck Sharp & Dohme (Australia) Pty Limited have arranged for any contacts made in relation to the above products to the Schering-Plough Pty Ltd address, to be re-directed to the address of the current sponsor.  

(Signed by)

Mayada Kayali

Delegate of the Secretary

Office of Medicines Authorisation

   23 June 2013