Supply of products by Merck Sharp & Dohme Australia Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On January 16 2013, 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 following products by Merck Sharp & Dohme Australia Pty Ltd, North Ryde NSW (“the Company”):

• mianserin hydrochloride (TOLVON) 10 mg tablet blister pack [Aust R 65541]
• toremifene (as citrate) (FARESTON) 60 mg tablet blister pack [Aust R 59743]

That do not conform with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order 69, in that the details of the previous sponsor (Schering-Plough Pty Ltd) are listed on the carton labels rather than that 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. This consent applies only to:
   1. batch 115474 for the product mianserin hydrochloride (TOLVON) 10 mg tablet blister pack [Aust R 65541]
   2. batch 1481121 for the product toremifene (as citrate) (FARESTON) 60mg tablet  blister pack [Aust R 59743]
2. The labels to be used are those bearing the details of the previous sponsor (Schering-Plough Pty Ltd) of the product.
3. No other changes have been made to the products:

• mianserin hydrochloride (TOLVON) 10 mg tablet blister pack [Aust R 65541]
• toremifene (as citrate) (FARESTON) 60mg tablet  blister pack [Aust R 59743]

4.       Details of the process in place to ensure continuous customer contact with the Company as the new sponsor are as described in correspondence from the Company dated December 12 2011 under Merrin Tulloch’s signature.