COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 26 June 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 Commercial Eyes Pty Ltd, gave consent to the importation and supply of
- Aripiprazole (Abilify) tablets 5 mg in blister pack [AUST R 90925]
- Aripiprazole (Abilify) tablets 10 mg in blister pack [AUST R 90997]
- Aripiprazole (Abilify) tablets 15 mg in blister pack [AUST R 90998]
- Aripiprazole (Abilify) tablets 20 mg in blister pack [AUST R 90999]
- Aripiprazole (Abilify) tablets 30 mg in blister pack [AUST R 91000]
that do not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the name and address on the labels are not that of the current sponsor
The consent is effective from 26 June 2015 until 30 June 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, Bristol-Myers Squibb 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 Otsuka Australia Pharmaceutical Pty Ltd.