Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Biogen Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 9 December 2015, a delegate of the Secretary of the Department of Health, on the application of Biogen Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of

• natalizumab (TYSABRI) 300 mg/15 mL concentrate for infusion vial [AUST R 112372]

that do not conform with the requirements of paragraph 3(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines, in that the sponsor’s old street address (for all batches given in Table 1) will be on the product labels until such time as labels with the revised sponsor address are approved by the Therapeutic Goods Administration and implemented in the supply chain.

Table 1: List of batches with sponsor’s old street address (Suite 1, Level 5, 123 Epping Road North Ryde) and old name (Biogen Idec Australia Pty Ltd) on the labels:

The consent is effective from 9 December 2015 until 24 June 2017.

The consent is subject to the following conditions:

1. This consent applies to those batches that are warehoused in Australia, those already produced, labelled and packed for Australia and held in overseas warehousing, or those currently in production for Australia.
2.  Other sponsor’s valid contact information such as telephone and postal address details will remain the same.
3. The new office location is clearly signposted within the building and postal communications are being received at the new office.
4. The sponsor will submit changes to labels and product information for approval under section 9D of the Act to reflect the revised sponsor’s name and address.