Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified - between 1 October 2014 and 30 September 2015

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On October 1, 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                    Astellas Pharma Australia Pty Ltd, gave consent to the importation and supply of:

tamsulosin hydrochloride (FLOMAXTRA) 400 microgram prolonged release tablet blister pack      [AUST R 115534] that does not conform with the requirements of subsection 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the carton labels states the previous sponsor contact details.

The consent is effective from October 1, 2014 until September 30, 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 to which this consent applies are those previously approved for the former sponsor, CSL Limited, and arrangements are in place with CSL for the redirection of any queries or complaints concerning the products to Astellas Pharma Australia Pty Ltd.

2.       No other changes have been made.