Revised: 5 September 2019

Medicines

Regulatory Guidance

Introductory Regulatory Guidance


Information about how to market a product in New Zealand that may have a therapeutic benefit as well as frequently asked questions.

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Current Regulatory Guidelines


How to seek approval for medicines.

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Evaluation Timeframes


Processing Times for New Medicine Applications (NMAs) and Changed Medicine Notifications (CMNs)

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Policy Statements


Medsafe's policy related to particular types of medicine and application

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Medsafe Performance


Medsafe's processing times for applications.

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