COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On August 1, 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”), by application of Ferring Pharmaceuticals Pty Ltd, gave consent to:
the importation and supply, of
Dinoprostone (CERVIDIL) 10 mg pessary sachet [AUST R 81391] that does not conform with the requirements of paragraphs 3(2)(l) and 3(13)(a) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the carton labels do not include the current sponsor’s name and address details and the foil label does not contain the name or registered trade mark of the sponsor or supplier of the goods, instead, the details of the previous sponsor bioCSL Limited are present.
The consent applies to batches:
- Batch MA13B09B, expiry date November 30, 2016 (2228 units); and
- Batch MA14X02B, expiry date June 30, 2017 (8000 units).
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those used by the previous sponsor bioCSL Limited, and arrangements are in place with the previous sponsor to ensure that all customer enquiries or complaints and adverse event reports are promptly forwarded to the new sponsor, Ferring Pharmaceuticals.