Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2021

  • revoked
  • Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2021: revoked, on 3 February 2022, by clause 5 of the Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2022 (SL 2022/7).

Version as at 3 February 2022

Coat of Arms of New Zealand

Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2021

(SL 2021/438)

Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2021: revoked, on 3 February 2022, by clause 5 of the Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2022 (SL 2022/7).

Cindy Kiro, Governor-General

Order in Council

At Wellington this 22nd day of December 2021

Present:
The Hon Grant Robertson presiding in Council

Note

The Parliamentary Counsel Office has made editorial and format changes to this version using the powers under subpart 2 of Part 3 of the Legislation Act 2019.

Note 4 at the end of this version provides a list of the amendments included in it.

This order is administered by the Ministry of Health.

This order is made under section 14 of the Epidemic Preparedness Act 2006

(a)

on the advice and with the consent of the Executive Council; and

(b)

on the recommendation of the Minister of Health made after receipt from the Director-General of Health of a written recommendation stating the matter required by section 14(2) of that Act.

Order

1 Title

This order is the Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2021.

2 Commencement

This order comes into force on 23 December 2021.

3 Enactment to which modifications made

This order modifies requirements imposed by the Medicines Act 1981 (the Act).

4 Requirement that only authorised prescriber may administer or procure medicine modified

Section 25 of the Act applies as if the following were inserted after section 25(3):

(4)

The Director-General may, by written notice, specify a person or class of persons to administer or procure the administration of a third dose of the Pfizer/BioNTech (Comirnaty, Tozinameran, BNT162b2) vaccine to any person who—

(a)

is aged 18 years or older; and

(b)

received their second dose of the Pfizer/BioNTech (Comirnaty, Tozinameran, BNT162b2) vaccine at least 4 months before the date on which the third dose is administered to that person.

(5)

A person or class of persons specified under subsection (4) does not require a prescription in order to administer or procure a third dose of the Pfizer/BioNTech (Comirnaty, Tozinameran, BNT162b2) vaccine.

(6)

Subsections (4) and (5) apply despite sections 17 to 24.

(7)

To avoid doubt, a third dose of the Pfizer/BioNTech (Comirnaty, Tozinameran, BNT162b2) vaccine administered or procured in accordance with subsection (4) is not a new medicine for the purposes of its administration or the procurement of its administration by a person or class of persons specified under subsection (4).

5 Revocation

This order is revoked when the Epidemic Preparedness (COVID-19) Notice 2020 expires or is revoked.

Michael Webster,
Clerk of the Executive Council.

Explanatory note

This note is not part of the order, but is intended to indicate its general effect.

This order is made under the Epidemic Preparedness Act 2006. It comes into force on 23 December 2021 and is revoked when the Epidemic Preparedness (COVID-19) Notice 2020 expires or is revoked. It modifies the requirements imposed by the Medicines Act 1981 (the Act) to enable the effective management of COVID-19 or its effects (or both).

The modifications to section 25 of the Act facilitate the administration by persons other than authorised prescribers of a third dose of the Pfizer/BioNTech (Comirnaty, Tozinameran, BNT162b2) (the COVID-19 Pfizer vaccine) at a dose interval of 4 months, rather than the current approved period of 6 months. This is to ensure that third doses of the COVID-19 Pfizer vaccine are accessible to the public and can be provided by a wider vaccinator workforce in order to mitigate the public health risk posed by COVID-19.

Clause 4 modifies the requirement in section 25 of the Act that only an authorised prescriber may administer or procure the administration of medicines (in this case, the COVID-19 Pfizer vaccine). New section 25(4) provides that the Director-General of Health may, by written notice, authorise a person or class of persons (vaccinators) to administer the COVID-19 Pfizer vaccine to a person who is aged 18 years or older, and who received their second dose of the COVID-19 Pfizer vaccine at least 4 months before the date on which the third dose is administered to that person. New section 25(5) clarifies that a vaccinator does not require a prescription in order to administer or procure a third dose. New section 25(7) provides that, to avoid doubt, a third dose of the COVID-19 Pfizer vaccine administered or procured in accordance with new section (25)(4) is not to be considered a new medicine for the purposes of its administration or procurement by a vaccinator.

Issued under the authority of the Legislation Act 2019.

Date of notification in Gazette: 22 December 2021.

Notes
1 General

This is a consolidation of the Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2021 that incorporates the amendments made to the legislation so that it shows the law as at its stated date.

2 Legal status

A consolidation is taken to correctly state, as at its stated date, the law enacted or made by the legislation consolidated and by the amendments. This presumption applies unless the contrary is shown.

Section 78 of the Legislation Act 2019 provides that this consolidation, published as an electronic version, is an official version. A printed version of legislation that is produced directly from this official electronic version is also an official version.

3 Editorial and format changes

The Parliamentary Counsel Office makes editorial and format changes to consolidations using the powers under subpart 2 of Part 3 of the Legislation Act 2019. See also PCO editorial conventions for consolidations.

4 Amendments incorporated in this consolidation

Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2022 (SL 2022/7): clause 5