Medicines Act 1981

Dealings with medicines and medical devices - Qualifying new medicines

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

You could also call this:

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

If the Director-General says no to a new medicine, they must tell the EPA it is not a qualifying new medicine. They must also give the EPA information about the medicine that might help the EPA decide what to do with it under the Hazardous Substances and New Organisms Act 1996. You can read more about this Act at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM381221. The Minister cannot let the medicine be sold or advertised unless the EPA says it is okay to release it under the Hazardous Substances and New Organisms Act 1996. The Minister needs written advice from the EPA before they can make a decision about the medicine.

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This page was last updated on 27 October 2025

View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55096.

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24A: Assessment of qualifying new medicines, or

"Checking new medicines to see if they are safe"

24C: Interpretation, or

"What special words mean in the Medicines Act"

Part 2Dealings with medicines and medical devices
Qualifying new medicines

24BProcedure if Director-General declines to grant approval

If the Director-General declines to grant an approval because the new organism is not a qualifying new medicine, then—
the Director-General must—
1. inform the EPA that the new medicine is not a qualifying new medicine; and
2. provide the EPA with a copy of all information (from assessing the safety, quality, and efficacy of the new medicine) that the Director-General considers may assist the EPA in deciding whether to approve or decline the application under the Hazardous Substances and New Organisms Act 1996; and
the Minister must not consent under section 20 or give provisional consent under section 23 to the distribution, sale, or advertising of the medicine unless the Minister receives written advice from the EPA that the medicine has been approved for release under the Hazardous Substances and New Organisms Act 1996.

Notes

Section 24B: inserted, on 30 October 2003, by section 5 of the Medicines Amendment Act (No 2) 2003 (2003 No 56).
Section 24B(a)(i): amended, on 1 July 2011, by section 53(1) of the Environmental Protection Authority Act 2011 (2011 No 14).
Section 24B(a)(ii): amended, on 1 July 2011, by section 53(1) of the Environmental Protection Authority Act 2011 (2011 No 14).
Section 24B(b): amended, on 1 July 2011, by section 53(1) of the Environmental Protection Authority Act 2011 (2011 No 14).