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Medicines Act 1981

Dealings with medicines and medical devices - COVID-19 vaccines

34A: Director-General may authorise off-label administration of COVID-19 vaccines

You could also call this:

"The boss of health can say it's okay to use COVID-19 vaccines in a different way."

Illustration for Medicines Act 1981

You can get a COVID-19 vaccine even if it's not being used exactly as intended. The Director-General can allow this if the Minister has agreed to the vaccine and a data sheet is approved. The Director-General will make a notice that says how the vaccine can be given. You might wonder who can get the vaccine and how it's given. The notice will say who can get it, how many doses, and how it's administered. It might also say when it can be given. Before making the notice, the Director-General thinks about the benefits and risks. They want to make sure it's a good way to manage COVID-19 risks. If the Director-General makes a notice, it doesn't mean the vaccine is a new medicine. People who are allowed to give vaccines can give it according to the notice. The notice is a type of law, and you can find out more about it in the Legislation Act 2019. You can also look at section 20 and section 24 to learn more.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=LMS711105.

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Part 2Dealings with medicines and medical devices
COVID-19 vaccines

34ADirector-General may authorise off-label administration of COVID-19 vaccines

  1. This section applies if—

  2. the Minister has given consent or provisional consent to a COVID-19 vaccine; and
    1. a data sheet is approved for the vaccine under the regulations.

      1. The Director-General may, by notice, authorise the administration of the vaccine other than in accordance with the data sheet.

      2. The notice may specify any 1 or more of the following matters in relation to the administration of the vaccine:

      3. who it may be administered to:
        1. the recommended number and frequency of doses:
          1. the recommended manner of administration:
            1. any circumstances in which it may be administered.

              1. Before issuing a notice under this section, the Director-General must—

              2. have regard to the likely therapeutic value of the proposed administration of the vaccine and the risk (if any) that the proposed administration of the vaccine may injuriously affect the health of any person; and
                1. be satisfied that the proposed administration of the vaccine is an appropriate measure to manage the risks associated with the outbreak or spread of COVID-19.

                  1. A COVID-19 vaccine is not a new medicine for the purpose of section 20 by reason only of—

                  2. a notice made under this section in relation to the vaccine; or
                    1. administration of the vaccine in accordance with the notice.

                      1. Any person or class of persons permitted by the Act or by regulations to administer the vaccine may administer the vaccine in accordance with the notice.

                      2. Nothing in this section limits section 24.

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

                      Notes
                      • Section 34A: inserted, on , by section 4 of the Medicines Amendment Act 2022 (2022 No 31).