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Medicines Act 1981

Schedule 1AA: Transitional, savings, and related provisions

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"Rules to help change to new medicine laws"

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You are looking at a part of the Medicines Act 1981. This part is about transitional, savings, and related provisions. It talks about some provisional consents that must be treated as given under a certain section of the Act. These consents are for medicines like Comirnaty and Necon 0.5/35. You need to know that these consents are treated as given under the section as amended by the Medicines Amendment Act 2021. This means the Medicines Amendment Act 2021 is considered to be in force when the consents were given. A provisional consent includes any renewal of the consent or a new consent for the same product. The notices for these consents were published in the Gazette, which is an official newspaper. These notices can be amended or replaced, and the changes are included in the references to the notices. The Medicines Amendment Act 2021 made some changes to the Medicines Act 1981, including adding this part about transitional provisions, as seen in the Medicines Amendment Act 2021.

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View the original legislation for this page at https://legislation.govt.nz/act/public/1986/0120/latest/link.aspx?id=LMS499190.

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1AATransitional, savings, and related provisions Empowered by s 5C

1Provisions relating to Medicines Amendment Act 2021

1Validation of certain provisional consents

  1. The following provisional consents must be treated as having been given under section 23 as amended by the Medicines Amendment Act 2021:

  2. the provisional consent for Comirnaty (COVID-19 mRNA vaccine) (as notified in Provisional Consent to the Distribution of a New Medicine (Gazette 2021-go338)):
    1. the provisional consent for Necon 0.5/35 (as notified in Provisional Consent to the Distribution of a New Medicine (Gazette 2020-go2377)):
      1. the provisional consent for 0.9% Sodium Chloride Injection (as notified in Provisional Consent to the Distribution of a New Medicine (Gazette 2020-go3009)):
        1. the provisional consent for the Panvax vaccine (as notified in Provisional Consent to the Distribution of a New Medicine (Gazette 2018-go6374)):
          1. the provisional consent for Brevinor 28 Day (as notified in Provisional Consent to the Distribution of New Medicines (Gazette 2020-go1987)):
            1. the provisional consent for H5N1 Influenza Vaccine (as notified in Provisional Consent to the Distribution of New Medicines (Gazette 2018-go576)).

              1. For the purposes of subclause (1),—

              2. the Medicines Amendment Act 2021 must be treated as having been in force when the provisional consents were given; and
                1. a reference to a provisional consent includes any renewal of the provisional consent or subsequent provisional consent for the same product; and
                  1. a reference to a notice in the Gazette includes any notice that amends or replaces that notice.

                    Notes
                    • Schedule 1AA clause 1: inserted, on , by section 6 of the Medicines Amendment Act 2021 (2021 No 16).