COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 27 October 2015, a delegate of the Secretary of the Department of Health, on the application of Pfizer Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of:
- DONNATAB tablets blister pack AUST R 60604 - batches 15DONT-03, 15DONT-04,
15DONT-05, 15DONT-06, 15DONT-07 and 15DONT-08
that do not conform with the requirements of paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the medicine labels do not include the specific advisory statements that will be required by the Medicines Advisory Statements Specification 2014, from 12 December 2015.
The consent applies only to the above batches and is effective from 27 October 2015 until 30 June 2016.