COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 15 May 2015, 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”), on the application of Bayer Australia Ltd, gave consent to the importation and supply of:
- IBEROGAST oral liquid solution bottle, AUST R 168967
that does not conform with the requirements of the paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the product labels bear the previous sponsor details.
The consent is effective from the date of this letter until 15 November 2016.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those currently approved;
- Arrangements are in place that any correspondence concerning the products will be promptly referred from the former sponsor (Flordis Pty Ltd ) to the current sponsor (Bayer Australia Ltd); and
- No other changes have been made to the products