COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 18 August 2015, a delegate of the Secretary of the Department of Health, on the application of Teva Pharma Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- fentanyl (as citrate) (ACTIQ) lozenges 200 micrograms with applicator in blister packs
[AUST R 91598]
- fentanyl (as citrate) (ACTIQ) lozenges 400 micrograms with applicator in blister packs
[AUST R 91600]
- fentanyl (as citrate) (ACTIQ) lozenges 600 micrograms with applicator in blister packs
[AUST R 91601]
- fentanyl (as citrate) (ACTIQ) lozenges 800 micrograms with applicator in blister packs
[AUST R 91602]
- fentanyl (as citrate) (ACTIQ) lozenges 1200 micrograms with applicator in blister packs
[AUST R 91603]
- fentanyl (as citrate) (ACTIQ) lozenges 1600 micrograms with applicator in blister packs
[AUST R 91604]
that do 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 labels do not contain the current sponsor details.
The consent is effective from 18 August 2015 until 31 December 2015.
The consent is subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former sponsor, Orphan Australia Pty Ltd (a member of the Aspen Australia group of companies), and arrangements are in place with the former sponsor, Orphan Australia Pty Ltd for the prompt referral of any queries or complaints concerning the products to Teva Pharma Australia Pty Ltd.
2. There are no other changes to the products.