COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 10 December 2015, a delegate of the Secretary of the Department of Health, on the application of Allergan Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- testosterone (ANDRODERM) 12.2 mg per patch transdermal drug delivery system sachet [AUST R 61818]
- testosterone (ANDRODERM) 24.3 mg per day patch transdermal drug delivery system sachet [AUST R 82398]
that do not conform with the requirements of paragraph 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order TGO 69 ‘General requirements for labels for medicines, in that the sachets do not have the batch number and expiry date prefixes on them.
The consent is effective from 10 December 2015 until supplies of the batches tabulated below are exhausted.
| ANDRODERM 12.2 mg patch | ANDRODERM 24.3 mg patch |
AUST R | 61818 | 82398 |
Pack size | 60 Patches | 30 Patches |
Batch number | 1037915A | 1051953 |
Expiry date | July 2017 | August 2017 |
Quantity | 5000 cartons | 5736 cartons |
New expected delivery of product | June 2016 | June 2016 |
The consent is subject to the following conditions:
- The sachet labels to which this consent applies have the batch number and expiry date in the same format as those provided with the email correspondence on 1 December 2015 and the cartons fully comply with paragraph 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order TGO 69.