Revised: 27 April 2017

Medicines

Approval Process

Introductory Regulatory Guidance


This information provides a starting point if you plan to market a product in New Zealand that may have a therapeutic benefit.

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Current Regulatory Guidelines


How to seek approval for medicines.

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Labelling


Information on the requirements for package labelling.

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Colouring


Permitted colourings for use in medicines and related products.

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Policy Statements


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

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Regulatory Timelines


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

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MAAC


The Medicines Assessment Advisory Committee (MAAC) advises the Minister of Health on the balance of benefits and risks of new medicines.

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Influenza Vaccine Composition


The current recommended composition for influenza vaccine.

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Forms and Templates


Application forms for regulatory activity related to medicines and medical devices.

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Schedule of Fees


Schedule of Fees Payable under the Medicines Act 1981 - Effective from 1 July 2018

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