COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On January 5 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”), by application of Apotex Pty Ltd gave consent to the importation and supply of:
Betahistine dihydrochloride (APO-BETAHISTINE) 16 mg uncoated tablet blister pack [AUST R 217105] that does not conform with the requirements of subclauses 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the blister foil and carton labels do not include the batch number and expiry date prefixes.
The consent is effective from January 5 2015 until August 31 2017.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The Dear Customer letter identical to that provided to the Therapeutic Goods Administration on November 28 2014 will be supplied to the pharmacist advising the pharmacist where the batch number and expiry date can be found.