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Medicines Act 1981

Dealings with medicines and medical devices - Quality and standards

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

You could also call this:

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

Illustration for Medicines Act 1981

You must have details about the quality of a medicine before you sell it or give it away. You need to know how to test the medicine and have a certificate showing the results of the tests for each batch. You have to give these details and certificates to an officer if they ask for them. If you do not follow these rules, you can get in trouble with the law. As an individual, you could go to prison for up to 3 months or pay a fine of up to $10,000. As a company, you could pay a fine of up to $100,000. You have to follow these rules when importing or making medicines in New Zealand, except for herbal remedies. This rule is part of the Medicines Act 1981, which can be found on the New Zealand legislation website. The rules have been updated over time, including a change made by the Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=DLM55451.

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Health and wellbeing > Public healthHealth and wellbeing > Healthcare servicesBusiness > Industry rules
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"Telling authorities about bad side effects of medicines you import or make"

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Part 2Dealings with medicines and medical devices
Quality and standards

42Duty of importer and manufacturer to have and produce specifications of medicines

  1. No importer or manufacturer shall sell, or distribute by way of gift or loan or sample or in any other way, or advertise for sale, or advertise the availability of, any medicine other than a herbal remedy unless he is in possession of—

  2. details of the specifications for testing the quality of that medicine; and
    1. a certificate of the results of testing in respect of every batch of that medicine distributed or to be distributed in New Zealand.

      1. Every importer or manufacturer in New Zealand shall, on demand, supply to an officer the details and certificates referred to in subsection (1).

      2. A person who contravenes this section commits an offence, and is liable on conviction—

      3. in the case of an individual, to imprisonment for a term not exceeding 3 months or a fine not exceeding $10,000:
        1. in the case of a body corporate, to a fine not exceeding $100,000.

          Notes
          • Section 42(3): substituted, on , by section 13 of the Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 (1998 No 20).