COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On April 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”), by application of Phebra Pty Ltd gave consent to the importation and supply, of
SYNTOMETRINE 1mL injection ampoule [AUST R 13396] that does not conform with the requirements of the paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the details of the previous sponsor Novartis Australia appear on the label instead of those of the current sponsor.
The consent is effective from April 4, 2014 until October 31, 2014.
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 as supplied with the Company letter. They are those used by Novartis in the New Zealand market, and comply in all other respects with TGO 69. The carton labels are overstickered with the Australian sponsor (Phebra) address and the AUST R number.
- Arrangements are in place for the prompt referral of all queries or complaints concerning the product to Phebra.
- The Dear Healthcare Provider letter supplied with the Company letter (our reference R14/416272) will be supplied with the product, and to the chief medical officers of State and Territory Health Departments as well as to Directors of pharmacy in all Australian hospital pharmacies. A copy should also be sent to the Royal Australian and New Zealand College of Obstetrics & Gynaecology. The letter sets out the circumstances behind this consent to supply and requests users to discard the New Zealand product information supplied with the product, and to refer to the approved Australian product information.