In any proceedings in respect of an alleged contravention of subclause (1) in which regulation 25A is pleaded in defence, the burden of proving that defence lies on the person charged.

6 New regulation 25A inserted (Exemptions from regulation 25)

After regulation 25, insert:

25A Exemptions from regulation 25

(1)

The requirement in regulation 25(1) for a label to display the appropriate designation does not apply in respect of a controlled drug supplied by a manufacturer or wholesaler,—

(a)

if the appropriate designation of the controlled drug described in regulation 25(2) has changed, for the period of 6 months immediately following the date on which the designation changed; and

(b)

if the designation as a controlled drug is new, for the period of 6 months immediately following the date on which the substance was added to Schedule 1, 2, or 3 of the Act.

(2)

The requirement in regulation 25(1) for a label to display the appropriate designation does not apply in respect of a controlled drug supplied by a retailer,—

(a)

if the appropriate designation of the controlled drug described in regulation 25(2) has changed, for the period of 9 months immediately following the date on which the designation changed; and

(b)

if the designation as a controlled drug is new, for the period of 9 months immediately following the date on which the substance was added to Schedule 1, 2, or 3 of the Act.

7 Regulation 53 revoked (Transitional)

Revoke regulation 53.

8 New Schedule 1AAA inserted

Insert the Schedule 1AAA set out in the Schedule of these regulations as the first schedule to appear after the last regulation of the principal regulations.

Schedule New Schedule 1AAA inserted

r 8

Schedule 1AAA Transitional, savings, and related provisions

r 2A

Part 1 Provision relating to Misuse of Drugs Amendment Regulations 2023

1 Exemption from requirement in regulation 25(1) for fentanyl supplied before 1 July 2023

The requirement in regulation 25(1) for a label to display the appropriate designation does not apply in respect of fentanyl supplied by a retailer, manufacturer, or wholesaler before 1 July 2023.

Rachel Hayward,
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, which come into force on 16 June 2023, amend the Misuse of Drugs Regulations 1977. The amendments include a transitional provision (new regulation 25A) relating to labelling requirements for—

controlled drugs, where the appropriate designation for the drug described in regulation 25(2) changes:
substances that become controlled drugs under the Misuse of Drugs Act 1975 (the Act) for the first time.

The effect of the transitional provision is to provide an exemption in relation to the controlled drug from the requirement to display the appropriate designation described in regulation 25(2)—

if the drug is supplied by a manufacturer or wholesaler, for a period of 6 months from the date of the change of status under the Act:
if the drug is supplied by a retailer, for a period of 9 months from the date of the change of status under the Act.

An exemption is also provided from the designation labelling requirement in respect of fentanyl supplied by a retailer, manufacturer, or wholesaler before 1 July 2023. The designation of fentanyl under the Act changes on 1 July 2023 from class B3 to class B1 (see the Misuse of Drugs (Classification and Presumption of Supply) Order 2022). The exemption permits a retailer, manufacturer, or wholesaler to supply fentanyl with labelling updated to reflect its new designation in advance of 1 July 2023.

Regulatory impact statement

A regulatory impact statement is not required for these regulations.

Issued under the authority of the Legislation Act 2019.

Date of notification in Gazette: 15 June 2023.

These regulations are administered by the Ministry of Health.

Misuse of Drugs Amendment Regulations 2023