THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On December 18 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the following products by Alphapharm Pty Ltd, Royal Exchange Post Office NSW (“the Company”):
- pantoprazole (as sodium sesquihydrate) (SALPRAZ) 20 mg enteric-coated tablets blister pack [Aust R 163888]
- pantoprazole (as sodium sesquihydrate) (SALPRAZ) 40 mg enteric-coated tablets blister pack [Aust R 163886]
That do not conform with paragraphs 3(2)(h) and 3(2)(i) of Therapeutic Goods Order 69, in that the required prefixes are not included on the blister foil labels.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This consent applies to the 30 tablets pack size batches 122285 (20 mg) and 122402 (40 mg) only.
- The blister foil labels for use are identical to those provided in correspondence from the Company dated November 28 2012.
- No other changes have been made to the products, including the carton labels.
- Prior to supply of these batches, the “Dear Pharmacist” letter attached to the electronic mail from the Company dated November 19 2012 will be communicated to pharmacists as planned.