Medicines legislation;
Pharmaceuticals;
Medical devices;
Therapeutic products;
Regulation;
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摘要:
This article evaluates New Zealand’s Medicines Amendment Bill 2011. This Bill is currently before Parliament and will amend the Medicines Act 1981. On June 20, 2011, the Australian and New Zealand governments announced their decision to proceed with a joint scheme for the regulation of therapeutic products such as medicines, medical devices, and new medical interventions. Eventually, the joint arrangements will be administered by a single regulatory agency: the Australia New Zealand Therapeutic Products Agency. The medicines regulations in Australia and New Zealand will be updated as part of this process. The Medicines Amendment Bill addresses some of the well-recognised deficiencies in the Medicines Act 1981. However, a comprehensive overhaul of the Act is not being undertaken. I argue that repealing and replacing the Medicines Act 1981 would be preferable and advisable, given the number of legal difficulties with the Act and, in particular, where it does not align with equivalent current international law.
机构:
Univ Huddersfield, Sch Appl Sci, Dept Pharm, Huddersfield HD1 3DH, W Yorkshire, England
Univ Auckland, Fac Med & Hlth Sci, Sch Pharm, Private Mail Bag 92019, Auckland, New ZealandUniv Notre Dame, Fremantle, WA, Australia
机构:
George Inst Global Hlth, Camperdown, NSW 2050, Australia
Univ Sydney, Sydney Med Sch, Sydney, NSW 2006, Australia
Optum, Lilyfield, NSW 2040, AustraliaGeorge Inst Global Hlth, Camperdown, NSW 2050, Australia
Taylor, Colman
Wonder, Michael
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机构:
Wonder Drug Consulting Pty Ltd, Cronulla, NSW 2230, AustraliaGeorge Inst Global Hlth, Camperdown, NSW 2050, Australia