THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On January 24 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 following products by Merck Sharp & Dohme Australia Pty Ltd, North Ryde NSW (“the Company”):
- olmesartan medoxomil / hydrochlorothiazide (OLMETEC PLUS) 40/25 mg tablet blister pack [Aust R 115661]
- olmesartan medoxomil / hydrochlorothiazide (OLMETEC PLUS) 40/12.5 mg tablet blister pack [Aust R 115737]
That do not conform with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order 69, in that the details of the previous sponsor (Schering-Plough Pty Ltd) are listed on the carton and blister foil labels, rather than that of the Company.
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 only to:
- batches 2TAHC04A, 2TAHC05A and 2TAHC06A for the product olmesartan medoxomil / hydrochlorothiazide (OLMETEC PLUS) 40/12.5 mg tablet blister pack [Aust R 115737]
- batches 2RUFC05A and 2RUFC06A for the product olmesartan medoxomil / hydrochlorothiazide (OLMETEC PLUS) 40/25 mg tablet blister pack [Aust R 115661]
2. The labels to which this consent applies are those currently used, having the previous sponsor details.
3. No other changes have been made to the products:
- olmesartan medoxomil / hydrochlorothiazide (OLMETEC PLUS) 40/25 mg tablet blister pack [Aust R 115661]
- olmesartan medoxomil / hydrochlorothiazide (OLMETEC PLUS) 40/12.5 mg tablet blister pack [Aust R 115737]
4. Arrangements are in place to ensure complaints or queries concerning these products will be dealt with promptly.