COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On July 23, 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 Sanofi-Aventis Australia Pty Ltd gave consent to:
the importation and supply, of
frusemide (LASIX) 10 mg/mL oral liquid bottle [AUST R 12405] that does not conform with the requirements of the clauses 3 & 8 of the Therapeutic Goods Order No. 77- Microbiological Standards for Medicines in that the product does not meet the minimum microbiological requirements with which a medicine must comply throughout its shelf life (clause 3 of the Order); and the product, which is a multidose medicine, does not fully comply with the British Pharmacopoeia, Appendix XVI C. Efficacy of Antimicrobial Preservation or the European Pharmacopoeia, Efficacy of Antimicrobial Preservation (5.1.3) (clause 8 of the Order).
The consent is effective from July 23, 2014 until March 31, 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- Batches of product not yet manufactured will be supplied labelled with the reduced shelf life of 18 months during the period of this s14 consent, as agreed in your email of 21 July 2014.