Medicines Act 1981

Dealings with medicines and medical devices - Quality and standards

41: Duty of importer or manufacturer to report untoward effects of medicines

You could also call this:

"Telling authorities about bad side effects of medicines you import or make"

You must tell the Director-General if you think a medicine you import or make has caused bad side effects. You do this by saying what the side effects are and how they happened, as far as you know. If you do not do this, you can get a fine of up to $1,000.

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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=DLM55450.

Topics:

Health and wellbeing > Public healthHealth and wellbeing > Healthcare servicesBusiness > Industry rules

40: Compliance with standards, or

"Medicines and devices must meet safety standards"

42: Duty of importer and manufacturer to have and produce specifications of medicines, or

"Medicine sellers must have test results and details to show medicine quality"

Part 2Dealings with medicines and medical devices
Quality and standards

41Duty of importer or manufacturer to report untoward effects of medicines

If at any time the importer or manufacturer in New Zealand of any medicine has reason to believe that any substantial untoward effects have arisen from the use of the medicine whether in New Zealand or elsewhere, the importer or manufacturer shall forthwith notify the Director-General of the nature of those effects and the circumstances in which they have arisen, so far as they are known to him.
Every person commits an offence against this Act and is liable on conviction to a fine not exceeding $1,000 who fails to comply with subsection (1).

Compare

1969 No 7 ss 17, 39(5)

Notes

Section 41(2): amended, on 1 July 2013, by section 413 of the Criminal Procedure Act 2011 (2011 No 81).