on the advice of the Minister of Health given after consultation with such organisations or bodies as appear to the Minister to be representative of persons likely to be substantially affected by these regulations.

1	Title
2	Commencement
3	Principal regulations
4	New regulation 44BA inserted (Restriction on prescribing gonadotropin-releasing hormone analogues)
	44BA	Restriction on prescribing gonadotropin-releasing hormone analogues
5	Regulation 64 amended (Offences)
6	Schedule 1AA amended
	Schedule New Part 2 inserted into Schedule 1AA
	Explanatory note
	Administrative Information

Regulations

1 Title

These regulations are the Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations 2025.

2 Commencement

These regulations come into force on 19 December 2025.

3 Principal regulations

These regulations amend the Medicines Regulations 1984.

4 New regulation 44BA inserted (Restriction on prescribing gonadotropin-releasing hormone analogues)

After regulation 44B, insert:

44BA Restriction on prescribing gonadotropin-releasing hormone analogues

(1)

An authorised prescriber must not prescribe a prescription medicine that is a gonadotropin-releasing hormone analogue for the treatment of a person with—

(a)

gender incongruence; or

(b)

gender dysphoria.

(2)

See Part 2 of Schedule 1AA for a transitional provision in respect of this regulation.

5 Regulation 64 amended (Offences)

In regulation 64(1)(a), after “44B(4),”, insert “44BA,”.

6 Schedule 1AA amended

In Schedule 1AA,—

(a)

insert the Part set out in the Schedule of these regulations as the last Part; and

(b)

make all necessary consequential amendments.

Schedule New Part 2 inserted into Schedule 1AA

r 6

Part 2 Provision relating to Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations 2025

3 Application of restriction in regulation 44BA

The restriction in regulation 44BA does not apply in respect of a person who has been prescribed a prescription medicine that is a gonadotropin-releasing hormone analogue for a purpose described in regulation 44BA before 19 December 2025.

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 19 December 2025, amend the Medicines Regulations 1984. The first amendment inserts a new regulation that restricts authorised prescribers prescribing prescription medicines that are gonadotropin-releasing hormone analogues. The prescription medicines may not be prescribed for the treatment of gender incongruence or gender dysphoria. The second amendment makes it an offence, punishable on conviction by a fine not exceeding $500, for an authorised prescriber to breach the restriction.

The prescription medicines subject to the restriction include buserelin, deslorelin, gonadorelin, goserelin, leuprorelin, nafarelin, and triptorelin. The restriction does not apply in respect of a person who has been prescribed a gonadotropin-releasing hormone analogue for the treatment of gender incongruence or gender dysphoria before the commencement of these regulations. The amendments do not prevent authorised prescribers prescribing gonadotropin-releasing hormone analogues for purposes other than the treatment of gender incongruence or gender dysphoria.

Regulatory impact statement

The Ministry of Health produced a regulatory impact statement on 29 July 2025 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: 20 November 2025.

These regulations are administered by the Ministry of Health.

Medicines (Restriction on Prescribing Gonadotropin-releasing Hormone Analogues) Amendment Regulations 2025