THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On August 16 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
The supply of the following products by Servier Laboratories (Australia) Pty Ltd, Hawthorn, Vic (“the Company”):
- Perindopril erbumine (IDAPREX 2) 2 mg tablet blister pack [Aust R 34266]
- Perindopril erbumine (IDAPREX 4) 4 mg tablet blister pack [Aust R 34267]
- Perindopril erbumine (IDAPREX 8) 8 mg tablet blister pack [Aust R 96738]
That do not conform with paragraph 3(2)(l) of Therapeutic Goods Order 69, in that the previous address of the distributor is listed on the labels on the outer cartons, instead of the current address.
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 applies until the end of 2012.
- The labels to which this consent applies have the old address of the distributor, Sandoz Pty Ltd, instead of the new address of the Company.
- No other changes have been made to the following products:
- Perindopril erbumine (IDAPREX 2) 2 mg tablet blister pack [Aust R 34266]
- Perindopril erbumine (IDAPREX 4) 4 mg tablet blister pack [Aust R 34267]
- Perindopril erbumine (IDAPREX 8) 8 mg tablet blister pack [Aust R 96738]
4. Arrangements are in place for the prompt referral of all queries and complaints about the products to the Company.