COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 15 January 2015, 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”), on the application of Apotex Pty Ltd, gave consent to the importation and supply of
- deferiprone (FERRIPROX) 500 mg tablets bottle [AUST R 93946]
- deferiprone (FERRIPROX) 25 g/250 mL oral solution bottle[AUST R 125665]
- deferiprone (FERRIPROX )50 g/500 mL oral solution bottle[AUST R 125666]
That do not conform with the requirements of the clause 3(2)(l) of Therapeutic Goods Order No. 69 (TGO 69, General requirements for labels for medicines), in that the labels do not include the correct sponsor details.
The consent is effective from the date of this letter until 30 April 2016.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former sponsor Orphan Australia Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor, Apotex Pty Ltd.