Schedule of Fees
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Introductory Regulatory Guidance
Categorisation of Products
Guidelines and Codes
Label Statements Database
Ministry of Health
New Zealand Legislation
New Zealand Gazette
Therapeutic Products Regulatory Regime
Revised: 21 September 2015
Guidance on the regulatory processes for suppliers in New Zealand of medicines and medical devices.
Information on good clinical research practice and the regulation in New Zealand.
Information for sponsors and manufacturers of medical devices
Guidance on the process of approving medicines for use in New Zealand.
Post market surveilance of medicines and medical devices.
What you need to do to ensure compliance with the law.
Regulatory forms and templates.
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