COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On July 7 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 Abbvie Pty Ltd gave consent to the importation and supply, of:
Ritonavir (NORVIR) 600 mg/7.5mL oral liquid bottle [AUST R 55004] that does not conform with the requirements of the paragraphs 3(2)(c) and 3(2)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the quantity of the active is expressed per mL instead of the quantity of active in a suitable dose [clause 4(2)], and the storage temperature is not in the form required by clause 7(1), stating ‘Store at room temperature (20-25°C)’ instead of ‘Store below 25°C, as required by the Order.
The consent is effective from July 7, 2014 until July 7, 2016.
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 your email dated 4 July 2014, including overstickering of the Australian sponsor’s address details and AUST R number of the product.