Consent given pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 20 April 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

• disofenin powder for injection multidose vial (HEPATOLITE kit for production of Technetium) (99mTc)[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 (TGO 69), in that the storage condition is not described as permitted by clause 7 of  TGO69

The consent is effective from the 20 April 2015 until the batch is exhausted.

The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. 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) and a 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.
2. The carton labels are those used for the USA market and will be over-stickered with the Australian sponsor and AUST R number.
3. No other changes have been made to the product.