COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 10 March 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Boucher & Muir Pty Ltd, gave consent to the importation and supply of
- ursodeoxycholic acid (URSOSAN) 250 mg capsule blister pack and [AUST R 218444]
that does not conform with the requirements of paragraph 3(13) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the blister foil label of a specified batch of the product does not include the batch number prefix.
The consent is effective from 10 March 2015 until the supply of this batch is exhausted.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The 'Dear Healthcare Professional' letter identical to that provided to the Therapeutic Goods Administration on 9 March 2015 (TGA ref R15/187168) will be distributed as advised in the electronic mail of 9 March 2015.
- The labels to which this consent applies are those provided in the letter of 14 February 2015.