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

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 29 June 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 Biogen Australia Pty Ltd, gave consent to the supply of

• interferon beta-1a (rch) (AVONEX)30 mcg (6MIU) powder for injection vial (attached Bioset device) with diluent syringe composite pack [AUST R 79752]
• interferon beta-1a (rch) (AVONEX) 30 microgram/0.5 mL injection pre-filled syringe        [AUST R 95419]
• interferon beta-1a (AVONEX Pen) 30 microgram/0.5 mL solution for injection prefilled pen and [AUST R 180136]

that does not conform with the requirements of paragraph 3(2)(1) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the product labels include the old sponsor name Biogen Idec Australia Pty Ltd until such time as labels with the revised sponsor name Biogen Australia Pty Ltd are approved by the TGA and implemented into the supply chain.

The consent is effective from the 29 June 2015 until 24 June 2017.

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

1. This consent applies to only 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. The only change to labels to which this consent applies is the change in the company name from Biogen Idec Australia Pty Ltd to Biogen Australia Pty Ltd. Existing sponsor contact information, such as telephone and address details, remain the same.
3. That labels to which this consent applies are those previously approved and arrangements for redirection is in place for electronic contact information such as email address.
4. Assurance that sponsor will notify the change in sponsor name for ARTG entries within three months of the sponsor name change in accordance with the Regulations 10A and 10F of the Therapeutic Goods Regulations 1990, and will submit changes to labels and Product Information for approval under section 9D of the Act to reflect the revised sponsor name.