Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - between 16 June 2014 and July 2015

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On June 16 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 Actavis Pty Ltd, gave consent to the importation and supply of:

• sumatriptan (as succinate) (SUMATRIPTAN-GA) 50 mg tablet blister pack [AUST R 187210]
• sumatriptan (as succinate) (SUMATRIPTAN-GA) 100 mg tablet blister pack [AUST R 187211]

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 old sponsor name and details are used on the labels.

The consent is effective from June 16, 2014 until July, 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 submitted in the company letter to the TGA dated April 15, 2014.