Consent given pursuant to sections 14 and 14A for the importation and supply of the therapeutic goods specified - Apotex Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On November 19 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 Apotex Pty Ltd gave consent to the importation and supply of:

• indapamide hemihydrate (CHEMMART INDAPAMIDE SR) 1.5 mg modified release tablet blister pack [AUST R 208006]
• indapamide hemihydrate (APO-INDAPAMIDE SR) 1.5 mg modified release tablet blister pack [AUST R 208007]
• indapamide hemihydrate (TERRY WHITE CHEMISTS INDAPAMIDE SR) 1.5 mg modified release tablet blister pack [ AUST R 208010]

that does not conform with the requirements of subsection 3(13)(a) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines , in that subclauses 3(2)(h) and (i) (the batch and expiry numbers) are not preceded by the appropriate prefixes.

The consent is effective from November 19 2014 until the batches specified below are exhausted.

The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. A ‘Dear Pharmacist’ letter identical to that provided to the Therapeutic Goods Administration on November 13 2014 advising them to remind patients to keep the blister packs with the correctly labelled carton must be provided with each of the affected batches.