Medicines Act 1981

Dealings with medicines and medical devices - Quality and standards

40: Compliance with standards

You could also call this:

"Medicines and devices must meet safety standards"

You must follow the standards for medicines and medical devices. If a standard is set for a medicine, you cannot sell something under a name that makes people think they are buying that medicine unless it meets the standard. You have to make sure the medicine or device you sell is what the buyer thinks it is. If someone asks for a specific medicine or device, you must sell them that exact thing unless you clearly tell them it is not what they asked for. You cannot add things to a medicine or device that are not allowed by the rules. If you add something that is not allowed, or add too much or too little of something, the medicine or device does not meet the standard. If you break the rules about selling medicines or devices, you can get in trouble with the law.

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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=DLM55449.

Topics:

Health and wellbeing > Public healthHealth and wellbeing > Healthcare servicesMoney and consumer rights > Consumer protection

39: Adulteration of medicines, or

"Don't tamper with medicines to keep people safe."

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

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

Part 2Dealings with medicines and medical devices
Quality and standards

40Compliance with standards

If a standard is prescribed in respect of a medicine, or a medical device, or the ingredient of a medicine, no person shall, in the course of any business, sell or supply any substance or article under a name that is likely to cause the person to whom the substance or article is sold or supplied to believe that that person is purchasing or otherwise acquiring that medicine, or that medical device, or a substance containing that ingredient, unless the substance or article, or the ingredient of the substance or article, complies with the standard.
If a person sells an article to a purchaser in response to a request for a medicine or a medical device of a kind for which a standard is prescribed, he shall be deemed to sell a medicine or medical device of that kind and under such a description as is specified in subsection (1) unless he clearly notifies the purchaser at the time of sale that the article is not of that kind.
Notwithstanding that a medicine, or a medical device, or an ingredient of a medicine, otherwise conforms with the standard prescribed for that medicine, medical device, or ingredient, it shall be deemed not to conform with that standard if anything has been added to it—
the addition of which is not expressly required or permitted by regulations made under this Act; or
in a quantity or proportion greater or lesser than that so required or permitted; or
that does not comply with the standard (if any) prescribed for that kind of thing.

Every person commits an offence against this Act who contravenes subsection (1).

Compare

1969 No 7 ss 6, 39(1)
Medicines Act 1968 s 65 (UK)