on the advice of the Minister of Health given after consultation with the organisations or bodies that appeared to the Minister to be representative of persons likely to be substantially affected by the regulations.

Regulations

1 Title

These regulations are the Medicines Amendment Regulations 2022.

2 Commencement

(1)

Regulations 6 and 8 come into force on 1 July 2022.

(2)

The rest of these regulations come into force on 19 May 2022.

3 Principal regulations

These regulations amend the Medicines Regulations 1984.

4 New regulation 44AA inserted (Alternative authorisation of vaccinators)

After regulation 44A, insert:

44AA Alternative authorisation of vaccinators

(1)

The Director-General or a Medical Officer of Health may authorise a person who meets the requirements of this regulation to—

(a)

prepare a vaccine:

(b)

administer a vaccine without a prescription.

(2)

An authorised person must, at all times while performing the tasks authorised under these regulations, work under the clinical supervision and direction of a suitably qualified health practitioner.

Application for authorisation

(3)

In applying for authorisation, a person must provide evidence to satisfy the Director-General or the Medical Officer of Health, as the case may be,—

(a)

that the person has successfully completed training as approved by the Director-General for either or both of the following:

(i)

preparing for administration the 1 or more vaccines for which the person has applied for authorisation:

(ii)

administering those vaccines; and

(b)

that the person also has the following competencies:

(i)

the person can carry out basic emergency techniques, including resuscitation and the treatment of anaphylaxis; and

(ii)

the person has knowledge of the safe and effective handling of immunisation products and equipment.

Conditions, etc, of authorisation

(4)

The Director-General or the Medical Officer of Health, as the case may be,—

(a)

must specify in the authorisation the 1 or more vaccines that the authorised person may prepare or administer (or both):

(b)

may, on application by the authorised person, amend the authorisation by adding or removing any vaccine.

(5)

An application to add a vaccine must be made in accordance with subclause (3)(a).

(6)

The Director-General or the Medical Officer of Health, as the case may be, may—

(a)

impose conditions on an authorisation as they think fit:

(b)

amend or revoke any condition by written notice to the authorised person.

(7)

An authorisation is valid for a period of 2 years, unless it is revoked earlier under subclause (8).

(8)

The Director-General or the Medical Officer of Health, as the case may be, may revoke an authorisation by written notice to the authorised person if satisfied that the authorised person has failed to comply with any condition on their authorisation.

5 Regulation 44AB amended (Authorisation of vaccinators)

(1)

In the heading to regulation 44AB, replace “vaccinators” with “COVID-19 vaccinators”.

(2)

After regulation 44AB(3), insert:

(4)

This regulation applies to the authorisation of COVID-19 vaccinators instead of regulation 44AA.

(5)

This regulation is revoked on 1 June 2023.

6 Regulation 61 amended (Fees)

(1)

In regulation 61(4), replace “$43,875” with “$79,877”.

(2)

In regulation 61(5), replace “$5,500” with “$5,731”.

(3)

In regulation 61(6), replace “$8,437” with “$85,202”.

(4)

In regulation 61(7), replace “$3,200” with “$79,877”.

7 Schedule 1 amended

In Schedule 1, Part 1, item 1090, delete “to a person 13 years of age or over”.

8 Schedule 5A amended

In Schedule 5A, third column, replace each figure in the first column of the following table with the corresponding figure in the second column:

13,750		14,328
845		880
845		880
1,054		1,123
845		880
300		313
1,030		1,097

Rachel Hayward,
acting for Clerk of the Executive Council.

Explanatory note

This note is not part of the regulations, but is intended to indicate their general effect.

These regulations amend the Medicines Regulations 1984 (the principal regulations). They make 2 sets of amendments.

The first set of amendments comes into force on 19 May 2022. It relates to vaccinations and the authorisation of people to prepare and administer them. The amendments—

insert new regulation 44AA into the principal regulations to enable the Director-General of Health or a Medical Officer of Health to authorise people to prepare or administer vaccines under the clinical supervision and direction of a suitably qualified health practitioner (see regulation 4):
amend regulation 44AB of the principal regulations so that a similar power to authorise people to prepare or administer a COVID-19 vaccine is revoked on 1 June 2023 (see regulation 5):
amend Schedule 1 of the principal regulations so that the influenza vaccine is not classed as a prescription medicine in certain cases, regardless of the recipient’s age (see regulation 7).

The second set of amendments (see regulations 6 and 8) comes into force on 1 July 2022. It increases the fees payable for—

a licence application specified in Schedule 5A of the principal regulations:
an application for the Minister of Health’s consent to sell, distribute, or advertise a new medicine (other than a new medicine that contains a novel active ingredient):
an application for the Minister’s consent to sell, distribute, or advertise a new related product:
an application for the Minister’s provisional consent to sell, supply, or use a new medicine:
a notification to the Director-General of Health of a material change made by the manufacturer of a medicine.

Regulatory impact statement

The Ministry of Health produced a regulatory impact statement on 28 July 2021 to help inform the decisions taken by the Government relating to the contents of this instrument.

A copy of this regulatory impact statement can be found at—

Issued under the authority of the Legislation Act 2019.

Date of notification in Gazette: 21 April 2022.

These regulations are administered by the Ministry of Health.

Medicines Amendment Regulations 2022