Medicines Amendment Act 2022
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Medicines Amendment Act 2022
Public Act |
2022 No 31 |
|
Date of assent |
22 June 2022 |
|
Commencement |
see section 2 |
Contents
The Parliament of New Zealand enacts as follows:
1 Title
This Act is the Medicines Amendment Act 2022.
2 Commencement
This Act comes into force on the day after the date of Royal assent.
3 Principal Act
This Act amends the Medicines Act 1981.
4 New section 34A inserted (Director-General may authorise off-label administration of COVID-19 vaccines)
After section 34, insert:
COVID-19 vaccines
34A Director-General may authorise off-label administration of COVID-19 vaccines
(1)
This section applies if—
(a)
the Minister has given consent or provisional consent to a COVID-19 vaccine; and
(b)
a data sheet is approved for the vaccine under the regulations.
Notice
(2)
The Director-General may, by notice, authorise the administration of the vaccine other than in accordance with the data sheet.
(3)
The notice may specify any 1 or more of the following matters in relation to the administration of the vaccine:
(a)
who it may be administered to:
(b)
the recommended number and frequency of doses:
(c)
the recommended manner of administration:
(d)
any circumstances in which it may be administered.
(4)
Before issuing a notice under this section, the Director-General must—
(a)
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
(b)
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.
Effect of notice
(5)
A COVID-19 vaccine is not a new medicine for the purpose of section 20 by reason only of—
(a)
a notice made under this section in relation to the vaccine; or
(b)
administration of the vaccine in accordance with the notice.
(6)
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.
(7)
Nothing in this section limits section 24.
Status of notice
(8)
A notice made under this section is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).
| Legislation Act 2019 requirements for secondary legislation made under this section | ||||
| Publication | The maker must publish it in accordance with the Legislation (Publication) Regulations 2021 | LA19 s 74(1)(aa) | ||
| Presentation | The Minister must present it to the House of Representatives | LA19 s 114 | ||
| Disallowance | It may be disallowed by the House of Representatives | LA19 ss 115, 116 | ||
| This note is not part of the Act. | ||||
Revocation
5 Order revoked
The Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2022 (SL 2022/7) is revoked.
Legislative history
7 June 2022 |
Introduction (Bill 138–1), first reading and referral to Health Committee |
|
20 June 2022 |
Reported from Health Committee |
|
21 June 2022 |
Second reading, committee of the whole House, third reading |
|
22 June 2022 |
Royal assent |
This Act is administered by the Ministry of Health.
Versions
Medicines Amendment Act 2022
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