Supply of products by Aspen Pharmacare Australia Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

SECTION14 AND 14A NOTICE

On September 12, 2013, 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”) gave his consent to:

(a)   the supply of the products -

• insulin (HYPURIN ISOPHANE) injection vial [Aust R 27803]
• insulin (HYPURIN NEUTRAL) injection vial [Aust R 27750]

by Aspen Pharmacare Australia Pty Ltd, ST LEONARDS, NSW (“the Company”);

That does not conform with the Therapeutic Goods Order (TGO) 69, in that the product is supplied with the UK packaging and labelling.

Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:

1. The product will be supplied in UK approved packaging and labelling as supplied with the Company letter.
2. Apart from labelling and packaging the UK product seeking to be supplied is identical to that which is currently registered in Australia.
3. The carton label main panel must be stickered with the appropriate Aust R numbers and Aspen Pharmacare’s contact details. This must cover the “Wockhardt” logo.
4. For the packaging of insulin (HYPURIN ISOPHANE) injection [Aust R 27803], the statement “subcutaneous/ intramuscular” on the UK packaging must be over stickered with “subcutaneous” to be consistent with the approved Australian packaging.
5. Where the packs are not sealed the UK pack insert will be replaced with the Australian CMI. Where the packs are sealed, the Australian CMI will be attached to the carton. Instruction will be provided to indicate that the Australian CMI replaces the UK pack insert.
6. Where supply of product is greater than 200 units in a month, product in Australia approved labelling and packaging must be supplied.