THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On January 29 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 product corifollitropin alfa (ELONVA) 150 micrograms/0.5 mL solution for injection prefilled syringe [Aust R 160645] by Merck Sharp & Dohme Australia Pty Ltd, North Ryde NSW (“the Company”)

That does 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) 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. The Company will maintain offices at the site of the Schering-Plough sponsor address.
2. Telephone redirection from Schering-Plough contact numbers to the Company will remain in place until the latest expiry date in the Schering-Plough product range is reached.
3. This consent will expire on June 30 2013.