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 ANTI-INFLAMMATORY PAIN RELIEF GEL diclofenac sodium 10mg/g tube [AUST R 93539] – batches 41037, 29606, 42136; and
- PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule blister pack [AUST R 191154] – batch 450471
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 31 December 2016.
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.