COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 31 August 2015, a delegate of the Secretary of the Department of Health, on the application of Abbvie Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- adalimumab (rch) (HUMIRA) 10 mg solution for injection pre-filled syringe (27 G)
[AUST R 238700]
that do not conform with the requirements of paragraph 3(2)(l), 3(2)(j)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines, in that the products will be supplied in Australia with US-labelled Tyvek blister and US syringe label in the Australian specific carton artwork. This is due to small volume of product and company’s inability to meet the minimum quantity order.
The consent is effective from 31 August 2015 until 31 August 2017.
The consent is subject to the following conditions:
- An assurance that the correct information, which adheres to the 3(2)(l), 3(2)(j) subclauses of the Therapeutic Goods Order No 69 is present on the Australian specific carton artwork.
- An assurance to notify health care professional of the change (i.e. that Australian carton contains US-labelled syringe) so that this is communicated to their patients. This will avoid confusion in patients, as it is possible that patients may think there is something wrong with the product because of the discrepancy between the syringe label and the carton label.
- An assurance that in the event the quantity of product supplied increases, Australian specific packaging for the pre-filled syringe label and Tyvek blister artwork (as approved in Cat3 application PM-2015-01764-1-3) on 15 June 2015 will be reinstated.