COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On March 12, 2014, the delegate of the Secretary of the Department of Health 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 oestriol (OVESTIN) 1 mg/g cream tube [Aust R 14515], by Merck Sharp & Dohme Australia Pty Ltd, NORTH RYDE, NSW (“the Company”);
That does not conform to Section 8 of the Therapeutic Goods Order No. 77—Microbiological standards for medicines, in that the product does not comply with the requirements for A.niger (A. brasiliensis), according to the British Pharmacopoeia Efficacy of Antimicrobial Preservation test.
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:
- The consent is ongoing.
- No other changes have been made to this product, and all other requirements of TGO 77 apply.