COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 27 February 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 Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific, gave consent to the importation and supply of:
- kit for production of Technetium(99mTc) disofenin (HEPATOLITE) powder for injection multidose vial [AUST R 19146]
that does not conform with the requirements of 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 by clause 7 of TGO69.
The consent is effective from 27 February 2015 until the following batches specified below are exhausted:
- 195 kits of the 5-vial carton product (Lot number 230047); and
- 35 kits of the 30-vial carton product (Lot number 230050).
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA with the Company letter of application and copy of the Australian package insert will be supplied with each affected batch stating the differences between the products and that the Australian approved storage conditions should continue to be applied;
- The carton labels are those used for the USA market and will be over-stickered with the Australian sponsor and AUST R number; and
- No other changes have been made to this product.