COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On August 5 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 GlaxoSmithKline Australia Pty Ltd gave consent to the importation and supply, of
retapamulin (ALTARGO) 1 % w/w ointment tube [AUST R 198947] that does not conform with the requirements of paragraph 3(2)(i)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the expiry date is not preceded by the expiry date prefix.
The consent is effective from August 5, 2014 until all stock for batches C677160 (expiry 03/2016) and C665449 (expiry 01/2016) have been exhausted or are expired.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The tube label is the currently approved label but the expiry details are printed on the wrong side of the tube;
- A ‘Dear Healthcare Provider’ (“Notification of printing misalignment”) letter identical to that provided in the Company letter on July 21, 2014 will be supplied with each affected batch recommending that the tubes are kept within the correctly labelled cartons; and
- No other changes have been made.