THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On April 4 2013 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 products
- Morphine sulfate (KAPANOL) 20 mg capsule blister pack [AUST R 48134]
- Morphine sulfate (KAPANOL) 50 mg capsule blister pack [AUST R 48135]
- Morphine sulfate (KAPANOL) 100 mg capsule blister pack [AUST R 48136]
- Morphine sulfate (KAPANOL) 10 mg capsule blister pack [AUST R 68439]
By Mayne Pharma International Pty Ltd, (“the Company”);
That does not conform with paragraphs 3(2)(1) of Therapeutic Goods Order (TGO) 69, in that the blister foils, label and cartons bear the name and address of the previous Company.
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:
- The consent applies all batches supplied until August 31 2014.
2. The labels for use are identical to those submitted with the letter from the Company of March 20 2013, viz blister foil and carton labels bearing the name and address of the previous sponsor, together with your assurance that the batch number and expiry date prefixes (which meet TGO 69) are printed on the blister foil labels immediately before the batch number and expiry date respectively (the letter of April 2 2013 refers).
3. No other changes have been made to the products:
- Morphine sulfate (KAPANOL) 20 mg capsule blister pack [AUST R 48134]
- Morphine sulfate (KAPANOL) 50 mg capsule blister pack [AUST R 48135]
- Morphine sulfate (KAPANOL) 100 mg capsule blister pack [AUST R 48136]
- Morphine sulfate (KAPANOL) 10 mg capsule blister pack [AUST R 68439]
4. Details of the process in place to ensure continuous customer contact with your company are as described in GlaxoSmithKline’s letter of March 14 2013.