COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 13 January 2016, a delegate of the Secretary of the Department of Health, on the application of Symbion Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of the specific batches of the products shown in the table below:
AUST R | Product name | Batch numbers |
192234 | CHEMMART PHARMACY IBUPROFEN 200mg soft gelatin capsule blister pack (20, 40 and 100 tablets pack) | VA4005, VA5001 |
192235 | PHARMACY CHOICE IBUPROFEN 200mg soft gelatin capsule blister pack (20, 40 and 100 tablets pack) | VG5002 |
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 all of the advisory statements that are required by schedule 2 of the Medicines Advisory Statements Specifications 2014 from 12 December 2015.
The consent is effective from 13 January 2016 until 12 June 2016 and applies only to batches specified in the table above.
The consent is subject to the following conditions:
- The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 18 December 2015.