Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - between 19 May 2014 and 19 May 2015

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On May 19 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”), by application of                AstraZeneca Pty Ltd, gave consent to:

The importation and supply of saxagliptin (as hydrochloride) (ONGLYZA) 5 mg film coated tablet blister pack [AUST R 157907] that does 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 carton label states the previous sponsor contact details.

The consent is effective from May 19, 2014 until May 19, 2015.

The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The labels are those currently supplied which state the previous sponsor details as well as the current sponsor (as the distributor);
2. Arrangements are in place to redirect all correspondence to the current sponsor (AstraZeneca); and
3. No other changes have been made.