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Medicines Act 1981

Dealings with medicines and medical devices - Qualifying new medicines

24A: Assessment of qualifying new medicines

You could also call this:

"Checking new medicines to see if they are safe"

Illustration for Medicines Act 1981

The Director-General can approve a new medicine under section 38I of the Hazardous Substances and New Organisms Act 1996 if you have the Minister's consent. You must also be acting under a delegation from the EPA given under section 19 of that Act. This means the Director-General needs to follow certain rules to approve a new medicine.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55094.

Topics:
Health and wellbeing > Public healthHealth and wellbeing > Healthcare services
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24: Distribution of changed medicines restricted, or

"Telling authorities about changes to medicines is required before selling them"

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24B: Procedure if Director-General declines to grant approval, or

"What happens if a new medicine is not approved by the Director-General?"

Part 2Dealings with medicines and medical devices
Qualifying new medicines

24AAssessment of qualifying new medicines

  1. The Director-General may grant an approval under section 38I of the Hazardous Substances and New Organisms Act 1996 for the release of a qualifying new medicine if he or she—

  2. has the consent of the Minister to do so; and
    1. is acting under a delegation from the EPA given under section 19 of that Act.

      Notes
      • Section 24A: inserted, on , by section 5 of the Medicines Amendment Act (No 2) 2003 (2003 No 56).
      • Section 24A(b): amended, on , by section 53(1) of the Environmental Protection Authority Act 2011 (2011 No 14).