COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On August 18 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 AFT Pharmaceuticals Pty Ltd, gave consent to:
the importation, of
atenolol (Atenolol-AFT) 50 mg/10 mL oral solution bottle [AUST R 184745] that does not conform with the requirements of the Therapeutic Goods Order (TGO) No. 80 ‘Child-Resistant Packaging Requirements for Medicines,’ in that the packaging used for the product is not child-resistant.
The consent is effective from August 18, 2014.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- Supply of the product must not occur until appropriate regulatory action to repackage into containers with child-resistant closures has been undertaken by AFT Pharmaceuticals, and approved by the TGA.