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Medicines Act 1981

Dealings with medicines and medical devices

22E: Rules for Minister’s consent by verification

You could also call this:

"How the Minister Makes Rules for Approving Medicines"

Illustration for Medicines Act 1981

The Minister can make rules about how to apply for consent by verification for medicines. You need to follow these rules when applying for consent by verification. The Minister must talk to groups that will be affected by the rules before making them, unless the changes are small. The Minister has to follow certain steps when making these rules. You can find out more about how these rules are published by looking at Part 3 of the Legislation Act 2019. The Minister makes these rules to help with medicines and medical devices. The rules are important because they help the Minister make decisions about medicines. The Minister can change the rules, but must usually talk to affected groups first. These rules are a type of law called secondary legislation.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=LMS1555618.

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22D: Minister’s consent by verification, or

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Part 2Dealings with medicines and medical devices

22ERules for Minister’s consent by verification

  1. The Minister may make rules setting out requirements—

  2. relating to applications for consent by verification; and
    1. relating to medicines for which consent by verification is sought; and
      1. for lodging an application for consent by verification; and
        1. for processing an application for consent by verification.

          1. Before making rules under this section, the Minister must consult the organisations or bodies that the Minister considers to be representative of persons likely to be substantially affected by the rules during a period of at least 8 weeks.

          2. Subsection (2) does not apply if the Minister is satisfied that the rules make an amendment that is minor in effect or corrects a minor or technical error.

          3. Rules made under this section are secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

          Notes
          • Section 22E: inserted, on , by section 7 of the Medicines Amendment Act 2025 (2025 No 66).