COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On November 28 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 Bayer Australia gave consent to the importation and supply of:
- dienogest (VISANNE) 2 mg tablets blister pack [AUST R 160465] that does not conform with the requirements of paragraph 3(2)(d) and 3(2)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the excipient lactose is not declared, and the storage condition is not as approved (it is stated as ‘store between 15 and 30 °C instead of the approved ‘store below 25°C’).
The consent is effective from November 28 2014 until June 30 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels/packaging to which this consent applies are those submitted with the application, being the Canadian versions; the cartons will be over labelled with the AUST R number and the Australian sponsor details. All other aspects relating to the product are unchanged; and
- A ‘Dear Healthcare Provider’ letter as provided to the Therapeutic Goods Administration on November 20 2014 outlining the circumstances behind supply of the product in non-compliant packaging, will be supplied with the product.