COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 10 July 2015, a delegate of the Secretary of the Department of Health, on the application of Eisai Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- carmustine (GLIADEL WAFER) 7.7 mg/implant implant sachet [AUST R 77283]
that do not conform with the requirements of the paragraphs 3(2)(a), 3(12)(b) and 7(1) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that both the carton and container (outer pouch) labels do not include the approved dosage form name and storage conditions, and the container label does not include either the name or registered trademark of the sponsor.
The consent is effective from 10 July 2015 on an on-going basis.
The consent is subject to the following conditions:
- The carton and outer pouch labels to be used are those provided with the letter of application dated 26 May 2015 together with the caution card.
- The carton label is over-stickered with relevant sponsor details and AUST R information as well as the relevant SUSMP warning statements, as undertaken in the letter of application.
- The product is supplied with the package insert provided with the letter of application, but the Australian consumer medicine information (CMI) must be used, where relevant.