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 HAYFEVER & SINUS PAIN RELIEF tablet blister pack [AUST R 189868] – batches 26498 & 41529 (24-tablet packs)
- HEARTBURN RELIEF pantoprazole (as sodium sesquihydrate) 20 mg enteric coated tablet blister pack [AUST R 183533] – batch BR01B003 (7-tablet and 14-tablet packs) and BR01B1003 (14-tablet packs)
- PHARMACY ACTION PARACETAMOL PLUS CODEINE 500mg/10mg tablets blister pack [AUST R 200691] – batches 450006 & 450558 (20-tablet packs) and 450399 & 450683 (40-tablet packs)
that do not conform with the requirements of 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 specific batches nominated in the application and subsequent correspondence relating to the application, but only until 30 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.