COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On December 5, 2013 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 dinoprostone (PROSTIN E2) vaginal gel 2 mg [Aust R 9984]
by Pfizer Australia Pty Ltd WEST RYDE, NSW (“the Company”);
That do not conform with paragraphs 3(2)(j) of Therapeutic Goods Order (TGO) 69, in that:
- Signal headings/warning statements are not presented as required by clauses 2 and 3(2)(g);
- The storage condition (Store at 2-8°C (Refrigerate. Do not freeze)) is not expressed as approved (clause 3(2)(j)).
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:
- This consent to supply applies until the end of March 2014, to batches Z07998 [128 units, expiry September 11, 2014], Z08820 [888 units, expiry September 11, 2014] and A02878 [2079 units, expiry February 28, 2015].
- The labels to which this consent applies are those supplied with the Company application, intended for use in Saudi Arabia and the Arabian Gulf countries.
- Further to the Company letter of application, the product to which this consent applies is identical in all respects to the product approved in Australia, apart from labelling differences.
- The Australian sponsor name and address, and the AUST R number, will be over stickered onto the carton labels of affected stock.