COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On September 25 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 Emerge Health Pty Ltd, gave consent to the importation and supply, of:
- poractant alfa (CUROSURF) 120 mg/1.5 mL intratracheal suspension vial [AUST R 99514]
- poractant alfa (CUROSURF) 240 mg/3 mL intratracheal suspension vial [AUST R 99515]
that does not conform with the requirements of subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the following particulars will be included on each vial:
- Vial label will contain the former sponsor’s (Ascent) name and contact details.
The consent is effective from September 25, 2014 until further notice.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The consent covers 364 vials of poractant alfa (CUROSURF) 120 mg/1.5 ml (AUST R 99514) and 485 vials of poractant alfa (CUROSURF) 240 mg/3 ml (AUST R 99515) representing the stock on hand at September 15, 2014.
- You will ensure that processes are in place for Emerge Health to successfully receive medical related questions and adverse event details, thereby allowing them to fulfil your sponsor requirements. In the event the vial is separated from the carton/package insert any medical related queries or any adverse event information is initially triaged by the former sponsor (Ascent) and then the contact forwarded to Emerge Health for follow up. This includes collection of adverse event information.