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 Novartis Pharmaceuticals Australia Pty Limited, 54 Waterloo Road, North Ryde NSW 2113, to supply FAMVIR FOR COLD SORES famciclovir 500 mg tablet blister pack (AUST R 201264) that does not comply with subclause 3(2)(a) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines (“the Order”)in that the container label (ie. blister foil label) only includes the abbreviated name of the product, Famvir, instead of the full product name, Famvir for Cold Sores. 

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

1.       The product complies with all other aspects of the Order.  

(signed by)

Mayada Kayali

Delegate of the Secretary

Office of Medicines Authorisation

  26 September 2012