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 Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- HEPATOLITE kit for production of Technetium (99mTc) disofenin powder for injection multidose vial [AUST R 19146]
that do not conform with the requirements of the paragraph 3(2)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the storage condition is not described as permitted in paragraph 7 of the Therapeutic Goods Order No. 69.
AUST R | Product name | Batch numbers |
19146 | HEPATOLITE kit for production of Technetium (99mTc) disofenin powder for injection multidose vial | 230052 230053 (5 and 30 vial packs) |
The consent is effective from 11 December 2015 until the batch numbers are exhausted.
The consent is subject to the following conditions:
- A ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration with the letter dated 19 December 2014 (for the related request, PM-2015-00028-1-2). A copy of the Australian package insert, stating the differences between the US and Australian-registered products, and that the Australian approved storage conditions should continue to be applied, will replace the US package insert;
- The carton labels are those used for the USA market and will be over-stickered with the Australian sponsor and AUST R number.