SECTion 14 AND 14A NOTICE
I, MAYADA KAYALI, delegate of the Secretary to the Department of Health and Ageing for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (‘the Act’) hereby give my consent, pursuant to sections 14 and 14A of the Act, for AFT Pharmaceuticals, 296 Burns Bay Road, Lane Cove, NSW 1595 to supply Paracetamol Osteo-Tab 665 mg modified release tablet blister pack (AUST R 202406) and Paracetamol Osteo-Tab 665 mg modified release tablet bottle (AUST R 202407) that do not comply with the requirements of the US Pharmacopoeia monograph for Acetaminophen Extended Release Tablets with regards to the test and limits for dissolution.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The product complies with all other aspects of the standard.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
2 November 2012