COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 2 December 2015, a delegate of the Secretary of the Department of Health, on the application of Arrow Pharma Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of:
- SPREN 100 aspirin 100mg tablet blister pack [AUST R 178592], and
- SPREN 100 aspirin 100mg tablet bottle [AUST R 201237]
that will not conform with the requirements of paragraphs 3(2)(g) and 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine, in that the medicine labels do not include:
- all of the new warning statements that will be required by schedule 2 of the legislative instrument made by the Minister under subsection 3(5A) of the Act from 12 December 2015, or
- the name and address of the current sponsor or supplier of the goods.
The consent applies from 2 December 2015 until 30 June 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 application.