Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Sanofi Aventis Australia Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 16 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 Sanofi Aventis Australia Pty Ltd, gave consent to the supply of

• hyaluronidase (HYALASE) 1500IU powder for injection ampoule [AUST R 27749]

that does not conform with the requirements of clauses 3(2)(I), 3(5)(a)(ii) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the product is supplied with the UK ampoule labels which is not compliant and their appearance on the ampoules is different to the Australian ampoule label.

The consent is effective from the 16 April 2015 until 31 March 2016.

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

1. this exemption applies to 700 units of Batch PP40410; Expiry - Oct 2017
2. the UK stock must be repackaged to:
   1. remove the two blister trays from the UK pack
   2. insert each tray into the 5 Ampoules AU approved carton
   3. packaged with currently approved Australian leaflet/s
3. repackaging must take place at the registered site for the Product namely DHL Supply Chain (Australia) Limited site at 52 Huntingwood Drive;
4. apart from the ampoule label the UK stock seeking to be supplied must be identical to that which is currently registered in Australia;
5. A separate batch number and expiry date sticker will be applied to the carton during the repackaging.
6. A ‘Dear Pharmacist’ letter identical to that provided to the TGA dated 24 March 2015 (TGA ref: R15/225465) must be provided with each of the affected batches.