COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 29 July 2015, a delegate of the Secretary of the Department of Health, on the application of Atnahs Pharma Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- ketorolac trometamol (TORADOL) injections 10 mg in 1 mL ampoule [AUST R 34356]
- ketorolac trometamol (TORADOL) injections 30 mg in 1 mL ampoule [AUST R 34357]
- ketorolac trometamol (TORADOL) 10 mg tablet in blister pack [AUST R 42060]
that do not conform with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order No. 69 –General requirements for labels for medicines (TGO 69), in that the labels include the name and contact details of the previous sponsor of the products.
The consent is effective from 29 July 2015 until 31 March 2016.
The consent is subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former sponsor, Roche Products Pty Ltd, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Atnahs Pharma Australia Pty Ltd.