COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On January 8, 2014 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”) gave his consent to:
(a) the supply of the products:
- oseltamivir (as phosphate)(TAMIFLU) 30 mg capsule blister pack [Aust R 145953].
- oseltamivir (as phosphate)(TAMIFLU) 45 mg capsule blister pack [Aust R 145957].
- oseltamivir (as phosphate)(TAMIFLU) 75 mg capsule blister pack [Aust R 76017].
by Roche Products Pty Ltd DEE WHY, NSW;
That does not conform with paragraphs 2(1) of Therapeutic Goods Order (TGO) 69, in that the shelf life of the product is 10 years (which does not comply with clause 2(1) of TGO 69 which requires that the expiry date is not more than 5 years after the date of manufacture).
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:
- The consent to supply applies indefinitely.
- No other changes have been made to the products:
- oseltamivir (as phosphate)(TAMIFLU) 30 mg capsule blister pack [Aust R 145953].
- oseltamivir (as phosphate)(TAMIFLU) 45 mg capsule blister pack [Aust R 145957].
- oseltamivir (as phosphate)(TAMIFLU) 75 mg capsule blister pack [Aust R 76017].