COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On February 4, 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:
- SYNTOMETRINE 1 mL injection ampoule [AUST R 13396]
by Phebra Pty Ltd HUNTERS HILL, NSW;
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the details of the previous sponsor Novartis Australia appears on the labels instead of those of the current one (Phebra).
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 October 2014.
- The labels to which this consent applies are those approved in relation to Novartis Australia, and comply in all other respects with TGO 69.
- Arrangements are in place for the prompt referral of all queries or complaints concerning the product to Phebra.