COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On November 12 2014, 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”), by application of UCB Australia Pty Ltd, gave consent to the importation and supply of
MIN-I-JET NALOXONE 400 microgram/1 mL injection syringe with needle [AUST R 29051] that does not conform with the requirements of paragraphs 3(2)(a), (g) & (l) and 3(5)(a)(i),(b) (i) & (b)(ii)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the labels do not state the approved trade name, the relevant SUSMP warnings, sponsor details (syringe only), the quantity of each excipient, a declaration that the product contains no microbial preservative, and that the accepted routes of administration are on the back panel of the carton instead of on main label.
The consent is effective from November 12 2014 until Batch NAL005B is exhausted.
The consent applies to one batch (batch No. NAL005B).
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those provided with the Company letter of application. The carton labels will be over-labelled with the batch and expiry details, the sponsor’s contact details and the AUST R number as stated in the electronic mail dated October 24 2014.
- A ‘Dear Healthcare Professional’ letter identical to that provided in the electronic mail dated November 6 2014 will be supplied to the Chief Medical Officers, Heads of Hospital Emergency Departments and Heads of Ambulance Services in all Australian states and territories.
- No other changes have been made to the product.