COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 11 December 2015, a delegate of the Secretary of the Department of Health, on the application of Generic Health Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- PHARMACY ACTION IBUPROFEN 200mg capsule-shaped tablets blister pack [AUST R 222147] – batches 341499A, 350728B, ACN4088 350497, 350145, 350728A
- PHARMACY ACTION Ibuprofen Plus Codeine film coated tablet blister pack [AUST R 194033] – batches 450032, 450609A, 450410, 450427, 450450, 450455, 450599, 450609; and
- PHARMACY ACTION PERIOD PAIN RELIEF naproxen sodium 275mg tablet blister pack [AUST R 195787] – batches AS4756, AS4757, AS4758
that do not conform to the requirements of paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine, in that the product labels do not include all of the new warning statements that will be required by the legislative instrument made by the Minister under subsection 3(5A) of the Act from 12 December 2015.
The consent applies to the nominated batches but only until 12 June 2017.
The consent is subject to the following conditions:
- the labels to which this consent applies are those previously approved by the TGA for these products, copies of which were provided with the request.