COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 15 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 AbbVie Pty Ltd, gave consent to the importation and supply of
- adalimumab (rch) (HUMIRA) 10 mg solution for injection pre-filled syringe (27G)
[AUST R 238700]
that does not conform with the requirements of the clauses of 3(2)(l), 3(2)(n) and 3(5)(6)(ii) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the name of Australian sponsor of the supplier of the goods, the Australian registration number and a statement “Use in one patient on one occasion only” are not present on the carton label.
The consent is effective from 15 June 2015 until 15 June 2017.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- There will be over labelling with a sticker on all supplied cartons with the Australian sponsor name, sponsor address, AUST R number and a statement “Use in one patient on one occasion only”. Further, the Australian approved Product Information leaflet will be supplied with the carton.
- In the event of the volume increase, Australian specific label will be reinstated.
- The sponsor clearly communicates that it no longer offers a latex-free HUMIRA adalimumab (rch) 10mg solution for injection. Such communication should be directed to prescribers, pharmacists and consumers.