THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On May 14, 2013 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:
(a) the supply of the products;
- raloxifene hydrochloride (RALOXIFENE GENERICHEALTH) 60 mg tablets blister [Aust R 199292]
- raloxifene hydrochloride (RALOXIFENE BW) 60 mg tablets blister [Aust R 199294]
- raloxifene hydrochloride (RALOXIFENE GH) 60 mg tablets blister [Aust R 199295]
By Generic Health Pty Ltd, Camberwell, VIC (“the Company”);
That do not conform with the dissolution requirements of the USP monograph for Raloxifene Hydrochloride tablets.
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:
- That the products conform with the agreed dissolution limit using the agreed dissolution test.