THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On July 24 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 pimecrolimus (Elidel) 1% w/w cream [Aust R 93680] by Meda Pharmaceuticals Pty Ltd, Chatswood NSW (“the Company”):

That does not conform with paragraph 3(2)(l) of the Therapeutic Goods Order 69, in that the product labels contain the details of the previous sponsor, Novartis Pharmaceuticals Australia Pty Ltd, rather than those 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 until the end of February 2013 for both 15 g and 30 g presentations.

2.       During the period for which this consent applies, the product will be supplied with labels previously used by Novartis Pharmaceuticals Australia Pty Ltd.

3.       No other changes have been made to the product, except those approved by the TGA.

4.       Arrangements are in place for any complaints or queries concerning the product to be promptly forwarded to Meda Pharmaceuticals Pty Ltd.