133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
2 September 2025
Greg Marshall
By email: [FYI request #31704 email]
Ref:
H2025070346
Tēnā koe Greg
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health – Manatū Hauora (the Ministry) on 22 July 2025 for:
“1. Pre-Action Notice Acknowledgement
Has the Ministry of Health received any pre-action legal notices or correspondence
threatening legal proceedings from SOMA Group Ltd, Gregory Marshall, or legal
representatives acting on their behalf in relation to the Medicinal Cannabis Scheme?
If so, please provide:
The date(s) of receipt
The recipient(s) within the Ministry
Any internal discussion or handling guidance (including any briefings or legal
assessments)
Any outgoing response or planned response (redactions accepted under s9(2)(h) or
s9(2)(g)(i) if applicable)
---
2. Ministerial Responsibility Change
Has the Ministry of Health been notified — formally or informally — that Minister David
Seymour has assumed portfolio responsibility for Medicinal Cannabis from Minister
Simeon Brown?
If so:
On what date did this occur?
What internal or external communications were generated regarding this shift in
responsibility?
Has Minister Seymour been briefed by the Ministry (or requested briefing material)
specifically on:
Clause 35
GMP regulatory settings
Stakeholder complaints or litigation threats
The “Pump the Brakes” letter (April 2024)
Any communications with the Ministry for Regulation
---
3. Ministry for Regulation Coordination
Since 1 June 2025, please provide:
A list of all meetings, email threads, or formal communications between the Ministry of
Health (including Medsafe or the Medicinal Cannabis Agency) and the Ministry for
Regulation regarding the Medicinal Cannabis Scheme.
Copies of the correspondence, or at minimum:
Dates and participants
Subject lines or topic summaries
Any briefing notes, memos, or shared policy frameworks
Any reference to:
Reform of the Medicinal Cannabis Scheme
GMP simplification
Clause 35 enforcement
Post-market monitoring
Removal of barriers to prescribing.”
The Ministry has identified two pieces of pre-action legal correspondence threatening legal
proceedings from you. Copies of these are outlined in Appendix 1 and appended to this letter.
Information relating to any internal discussion is withheld under section 9(2)(h) of the Act on the
basis of legal professional privilege.
A meeting was held between representatives of the Ministry of Health and the Ministry for
Regulation on 17 July 2025 which is considered to be in scope of your request. The associated
correspondence is outlined in Appendix 1 and appended to this letter.
The Ministry of Health holds no other information considered to be in scope of your request in
relation to this meeting.
Please note, information that is deemed out of scope has been excluded from the response.
Where information is withheld under section 9 of the Act, I have considered the countervailing
public interest in release in making this decision and consider that it does not outweigh the need
to withhold at this time.
If you wish to discuss any aspect of your request with us, including this decision, please feel
free to contact the OIA Services Team on:
[email address].
Under section 28(3) of the Act, you have the right to ask the Ombudsman to review any
decisions made under this request. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests.
Nāku noa, nā
Phil Knipe
Chief Legal Advisor
Corporate Services | Te Pou Tiaki
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Appendix 1: List of documents for release
#
Date
Document details
Decision on release
1
8 July 2025
Email correspondence:
Pre-
Released in full.
Action Notice: Breach of Statutory
Duty and Regulatory Misfeasance
by Medsafe Group Manager,
Chris James
1A 30 June 2025
Attachment:
OIA response
H2025067067
1B
1 July 2025
Attachment:
OIA response
H2025066224
1C
2 July 2025
Attachment:
Email decision on
OIA response H2025066293
1D
26 June 2020
Attachment:
Cabinet Office
Circular CO(20)2 – Impact
Analysis Requirements
1E
2019
Attachment:
Clause 35 of the
Misuse of Drugs (Medicinal
Cannabis) Regulations 2019
1F
2020
Attachment:
Sections 12-14 of the
Public Service Act 2020
1G
3 May 2025
Attachment:
Email response from Some information is withheld
Sally King
under section 9(2)(a) of the Act,
to protect the privacy of natural
persons.
2
9 July 2025
Email correspondence:
PRE-
Released in full.
ACTION NOTICE Advertising
Guidance: Medicinal Cannabis”
(July 2025) –
Unlawful and Ultra Vires
3
17 July 2025
Email correspondence: Catch up Some information is withheld
request – regulatory response
under section 9(2)(g)(i ) of the
issue – medicinal cannabis
Act, to maintain the effective
conduct of public affairs
through the protection of such
Ministers, members of
organisations, officers, and
employees from improper
pressure or harassment.
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Document 1
Out of scope
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From: Greg Marshall <[email address]>
Sent: Tuesday, 8 July 2025 10:19 am
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To: Chris James <[email address]>; Medicinal Cannabis <[email address]>
Cc: Simon Medcalf <[email address]>; Kevin Lampen-Smith <[email address]>;
Audrey Sonerson <[email address]>; David Seymour (MIN) <[email address]>;
Simeon Brown (MIN) <[email address]>; Phil Knipe <[email address]>
Subject: Pre-Action Notice: Breach of Statutory Duty and Regulatory Misfeasance by Medsafe Group Manager, Chris
James
INFORMATION
Pre-Action Notice: Breach of Statutory Duty and Regulatory Misfeasance by Medsafe Group
Manager, Chris James
From: Gregory P. Marshall LLB
Founder – SOMA Group Ltd
Email: [email address] | Phone: 021 768 884
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Date: 8 July 2025
To: Chris James, Group Manager, Medsafe
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Cc: Audrey Sonerson (Director-General, Ministry of Health); Kevin Lampen-Smith (Deputy Director-General,
Regulation); Crown Law; Office of the Ombudsman (for information)
Subject: Formal Notice of Breach of Statutory Duty, Misfeasance in Public Office, and OIA Violations Relating to
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Administration of the Medicinal Cannabis Scheme
Tēnā koe Chris,
I write on behalf of patients, prescribers, and licensed producers affected by the administration of the Medicinal
Cannabis Scheme. This correspondence constitutes formal notice of intent to initiate legal, public, and political
proceedings for serious and sustained breaches of public duty committed under your delegated authority.
I make this statement with full standing based on documented harm, delegated Crown powers exercised by your
RELEASED
office, and official evidence released under the Official Information Act 1982 (OIA).
Summary of Material Breaches
1. Breach of Clause 35 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019
Clause 35 required the Ministry to "review the operation of these regulations as soon as practicable" after 1 April
2023. OIA H2025067067 (30 June 2025) confirms:
"This has not yet been undertaken by the Ministry."
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No repeal or amendment of this clause has been substantiated. The failure to conduct a review as required by law
constitutes a breach of statutory duty.
2. Contradictory and Misleading Public Statements
OIA H2025066224 (1 July 2025) claims:
"As previously advised, the review was completed in line with the required process."
This contradicts the earlier response and constitutes a breach of section 19 of the OIA and a failure to act in
accordance with public sector integrity and honesty obligations.
3. Suppression of Scheme Review Evidence and Stakeholder Exclusion
OIA H2025066293 (8 July 2025) confirms that a multi-agency hui involving Medsafe, MSD, ACC, Medical Council, and
RNZCGP took place in May 2025.
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Documents include:
Agendas and minutes
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Slideshow presentations
Internal Ministry correspondence
Despite formal requests, industry and patient groups were excluded. Your office failed to disclose this hui's
existence in prior responses, misleading Parliament, the public, and stakeholders.
4. Failure to Conduct Any Performance Evaluation of the Scheme
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OIA H2025067067 also confirms:
"The Ministry has not conducted any formal evaluation of patient access, affordability, equity
outcomes, or industry development."
This is a breach of Cabinet Office Circular CO(20)2 and sections 12–14 of the Public Service Act 2020. It is evidence of
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systematic regulatory abdication.
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Consequences
Patients:
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Unlawful overpayment: up to $1,000/month for basic CBD treatments
Documented harm due to unaffordability and delayed access
Licensed Producers:
Market exclusion, co
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Discriminatory application of standards and blocked supply pathways
Public Interest:
Breach of Cabinet-mandated policy goals (access, affordability, equity)
Collapse of domestic market (90% imports)
Legal Liability
2
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INFORMATION
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Document 1A
•
Any cost-benefit analyses or compliance cost estimates for GMP standards, as
referenced in the RIS.”
The criteria (1-6) referred to in your request come from the Regulatory Impact Statement (RIS)
(10 December 2019, point 3.2) and were used to assess the likely impacts of the various policy
options under consideration in relation to the quality standard and the prescribing requirements.
They do not directly refer to the performance of the Medicinal Cannabis Scheme.
Section 8 of the RIS covers monitoring, evaluation and review, and includes various actions for
the Ministry to undertake once the Scheme has been running for an appropriate amount of time.
The Medicinal Cannabis Agency (MCA) monitors the growth of the industry through the number
of licences, verified products and related activities, and supply data. We have seen growth in
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the number of products available in a range of formulations and types of product, which would
indicate there is increased availability of quality products. This is supported by the supply data
held by Medsafe, which indicates increased demand as the Scheme has become more
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established.
As mentioned in the RIS, it has been important to allow sufficient time for the Scheme and the
industry to be firmly established, with a range of available products, before carrying out
assessment of satisfaction levels from prescribers or patients (including affordability and equity).
It is expected that these actions will be undertaken in due course.
As this has not yet been undertaken by the Ministry, your request is refused under section
18(g)(i) of the Act, as the information requested is not held by the Ministry and there are no
INFORMATION
grounds for believing that the information is held by another agency subject to the Act. Please
note that while the Act allows New Zealanders to ask for information from Ministers and
government agencies, there is no requirement for agencies to create new information or compile
information they do not currently hold.
If you wish to discuss any aspect of your request with us, including this decision, please feel
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free to contact the OIA Services Team on: [email address].
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Under section 28(3) of the Act, you have the right to ask the Ombudsman to review any
decisions made under this request. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
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Ministry website at: www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests.
Nāku noa, nā
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Simon Medcalf
Deputy Director-General Regulation and Monitoring | Te Pou Whakamaru
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Document 1B
I understand that the Ministry has already provided a significant amount of information to you in
previous requests, including decision making documents such Cabinet materials, briefings, and
Regulatory Impact Statements.
What oversight or review process, if any, was in place post-July 2024? The Medicinal Cannabis Amendment Regulations came into effect on 5 July 2024, and whilst
the Ministry does not have a formal monitoring process in place to specifically assess the impact
of these changes, they were made in response to requests from the industry, for example to
facilitate export. Medsafe engages with representatives from industry on a regular basis to
discuss any potential issues and welcomes feedback on the Scheme.
What steps will the Ministry now take to restore regulatory stewardship?
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As previously advised by my correspondence to you of 26 July 2024, the Regulation and
Monitoring Directorate was established within the Ministry of Health in late 2023, in part to
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strengthen the Ministry’s approach to regulatory stewardship. A,Chief Regulatory Officer role
was established, and on the 2 September 2024, the Regulatory Stewardship Team was
established to further strengthen this function.
The Team’s focus is to understand each regime to determine how it can support regulatory
leaders to improve regulatory stewardship practices in the regimes they are responsible for, and
this includes the Medicinal Cannabis regime.
Regulatory stewardship encapsulates the active governance, monitoring and care of regulatory
INFORMATION
systems to ensure that all components work together to achieve intended outcomes and keep
the system fit for purpose over the long term. This is an ongoing process, and it is expected that
all systems will be reviewed on a regular basis.
Will a correction be issued regarding Simon’s earlier statements?
OFFICIAL
From your correspondence we understand that you are referring to the following exerts you
have provided:
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1. “Medsafe and the Medicinal Cannabis Agency led the review of the Medicinal Cannabis
Regulations competently…”
2. “The Agency works closely with the Regulatory Stewardship Team…”
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3. “Industry were consulted on both the policy changes and the wording…”
As previously advised, the review was completed in line with the required process, the Agency
works with the Regulatory Stewardship Team, and industry were consulted on both the policy
and wording during the process of changing the Medicinal Cannabis Regulations.
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What SOPs exist for documenting regulatory decision-making—and why weren’t they followed? The Medicinal Cannabis Agency have Standard Operating Procedures in place, which
document processes and procedures in relation to the operational handling and processing of
individual applications for medicinal cannabis licences or products. The Ministry is happy to
provide you with a copy of these SOPs if these are of interest.
I trust this information fulfils your request. If you wish to discuss any aspect of your request with
us, including this decision, please feel free to contact the OIA Services Team on:
[email address].
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Document 1B
Under section 28(3) of the Act, you have the right to ask the Ombudsman to review any
decisions made under this request. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry website at: www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests.
Nāku noa, nā
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Simon Medcalf
ACT
Deputy Director-General Regulation and Monitoring | Te Pou Whakamaru
INFORMATION
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Document 1C
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Document 1D
CO (20) 2
Cabinet Office
CO (20) 2
Circular
26 June 2020
Intended for
All Ministers
All Chief Executives
All Senior Private Secretaries
All Private Secretaries
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All officials involved in the preparation of Cabinet papers
_______________________________________________________________
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Impact Analysis Requirements
Introduction
1
This circular sets out the requirements for Ministers and agencies seeking
approvals relating to government regulatory proposals.
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2
This circular replaces CO (17) 3, and updates Cabinet’s requirements for impact
analysis. The changes reflect:
2.1
minor process amendments or clarifications identified following a review
of the implementation of the 2017 Impact Analysis Requirements; and
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2.2
decisions taken by Cabinet in June 2020 to introduce impact analysis
exemptions for declared emergency situations and additional options for
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urgent regulatory proposals [GOV-20-MIN-0017].
3
The Impact Analysis Requirements incorporate the Government Expectations for
Good Regulatory Practice.1 Regulatory agencies are expected to adopt a whole-
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of-system view, and take a proactive, collaborative approach to the care of the
regulatory system(s) within which they work. The Impact Analysis Requirements
focus in particular on the expectation that agencies provide robust analysis and
advice to Ministers before decisions are taken on regulatory change.
4
This circular outlines the purpose and role of the Impact Analysis Requirements
and sets out the requirements. It covers the following:
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4.1 government regulatory proposals;
4.2 early engagement to support high quality impact analysis;
4.3 exemptions from providing a Regulatory Impact Statement;
1 https://treasury.govt.nz/publications/guide/government-expectations-good-regulatory-practice
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CO (20) 2
4.4 content and form of Regulatory Impact Statements;
4.5 Quality Assurance arrangements;
4.6 the “Impact Analysis” section in Cabinet papers;
4.7 government regulatory proposals with inadequate Impact Analysis; and
4.8 publication of Regulatory Impact Statements and Supplementary Analysis
Reports.
5
The updated Impact Analysis Requirements set out in this circular apply from
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1 July 2020. The Regulatory Impact Statement templates, Quality Assurance
criteria, Treasury forms, and guidance on the Impact Analysis Requirements are
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all available on the Treasury website (https://treasury.govt.nz/information-and-
services/regulation/impact-analysis-requirements-regulatory-proposals).
6
Ministers and Chief Executives should ensure that:
6.1
all staff involved in the preparation of submissions for Cabinet and
Cabinet committees are familiar with the contents of this circular;
6.2
the material in this circular is conveyed to all Crown entities and State
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sector agencies that may be involved in policy initiatives relating to
government regulatory proposals.
Purpose and role of the Impact Analysis Requirements
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7
The Impact Analysis Requirements support and inform the government’s
decisions on proposals for regulatory change. They are both a process and an
analytical framework that encoura
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approach to policy development.
8
The Impact Analysis framework involves defining the policy or operational
problem that needs to be addressed, identifying the policy objectives and the full
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range of feasible options for addressing that problem. It also includes analysing
those options for their potential impacts and assessing their costs, benefits and
risks, carrying out consultation, implementation planning, and arrangements for
ongoing monitoring, evaluation and review.
9
The Impact Analysis Requirements are intended to help advisers and decision-
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makers avoid the potential pitfalls that arise from natural human biases and mental
short-cuts, including by seeking to ensure that:
9.1
the underlying problem or opportunity is properly identified, and is
supported by available evidence;
9.2
all practical options to address the problem or opportunity have been
considered;
2
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CO (20) 2
9.3
all material impacts and risks of proposed actions have been identified and
assessed in a consistent way, including possible unintended consequences;
and
9.4
it is clear why a particular option has been recommended over others.
10
The Impact Analysis Requirements also contribute to the transparency and
accountability of government through the routine publication of Regulatory
Impact Statements.
Government regulatory proposals
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11
All policy proposals taken to Cabinet for approval that include a government
regulatory proposal must be accompanied by a Regulatory Impact Statement,
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unless an exemption applies.2
12
A Regulatory Impact Statement is a government agency document in which the
agency provides a summary of its best impact analysis and advice relating to a
government regulatory proposal. This impact analysis should be completed and
summarised before the Cabinet paper is drafted.
13
A “government regulatory proposal” means a proposal that will ultimately require
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creating, amending, or repealing primary or secondary legislation.3 This includes
proposals that involve:
13.1
decisions to introduce legislative changes that are merely enabling (the
substantive decisions as to whether and what sort of intervention will be
made later), including creating or amending a power to make secondary
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legislation;
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13.2
decisions to create, or amend a statutory authority to charge third parties to
cover the costs of a government activity (i.e. cost recovery proposals);
13.3
decisions on discussion documents that have the effect of narrowing down
the range of options
UNDER , including regulatory options, being considered;
13.4
“in principle” policy decisions and intermediate policy decisions,
particularly those where regulatory options are narrowed down (e.g.
limiting options for further work/consideration);
13.5
seeking negotiating mandates for, or concluding, or seeking approval to
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sign, treaties with regulatory impacts;
13.6
secondary legislation made by a Minister under an enabling power in an
Act and the Minister’s decision is referred to Cabinet for noting;
2 The grounds and process for granting exemptions are covered in paragraphs 22 to 29.
3 “Secondary legislation” means an instrument that is not an Act (primary legislation) but has legislative
effect or is stated by an Act to be secondary legislation – see the Legislation Act 2019.
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13.7
decisions about a regulatory proposal that has previously been announced,
for example by a Minister or in a political party manifesto.
14
A Regulatory Impact Statement must be provided when papers are submitted to
Cabinet committees (or a similar Ministerial group) for policy approval. In rare
circumstances, the policy proposal and draft legislation may be submitted
together. In these cases, the usual procedure is for the paper to be submitted to the
relevant Cabinet policy committee rather than directly to the Cabinet Legislation
Committee.
15
During the parliamentary process, it often becomes necessary to amend a Bill.
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The policy content of the amendments may be such that further approvals from
Cabinet are needed for new policy or to alter existing policy approvals. If so, the
original Regulatory Impact Statement should be updated to indicate how the
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changes affect the agency’s impact analysis (e.g. how they alter the nature and/or
magnitude of the impacts).
Early engagement to support high quality Impact Analysis
16
Inadequate impact analysis often arises from incomplete problem definition,
unclear objectives and a failure to consider all feasible options. As these are key
foundations of policy analysis, inadequacies in these areas cannot be easily fixed
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at a later stage, with consequent impacts on the quality of the impact analysis.
17
The Treasury’s Regulatory Quality Team and the relevant Treasury policy team
will provide feedback on these areas at the request of the agency policy team.
This feedback is most effectively provided in the early stages of policy
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development – for example, during the planning of a consultation exercise or the
drafting of a discussion document, which may eventually lead to a regulatory
proposal. It will focus on the types of things a Quality Assurance panel would
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look for in the final assessment of the problem definition, objectives and options
identification. Early indications of what is expected should assist agencies to plan
and develop their analysis. The feedback will be provided within a reasonable
timeframe on a best-endeavours basis.
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18
It is strongly recommended that agencies seek this feedback, including from their
own Quality Assurance panel or specialist. This assistance may be especially
valuable when the agency considers that the problem is important in terms of its
human, social, economic or environmental impacts, and that the policy process is
likely to explore material options to create, amend or repeal primary or secondary
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legislation.
19
This information can be provided as soon as agencies have some initial ideas to
test, and before they proceed further with the analysis. There is an engagement
form available for this purpose on the Treasury website, or agencies may have
their own document, which sets out information on the proposed problem
definition, objectives and options.
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20
If it is already apparent at this point that the Impact Analysis Requirements are
applicable (and how they will apply) to the policy exercise, the Treasury will also
confirm this as part of the early feedback. Otherwise, this can be confirmed at a
later stage.
Exemptions from the requirement for a Regulatory Impact Statement
21
While use of the Impact Analysis framework is encouraged and always
recommended in the development of advice on any form of government policy
initiative, a Regulatory Impact Statement is not required for certain types of
government regulatory proposals.
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Technical or case-specific exemptions
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22
A Regulatory Impact Statement is not required where a government regulatory
proposal:
22.1
is suitable for inclusion in a revision Bill (as provided for in the
Legislation Act 2012);
22.2
is suitable for inclusion in a Statutes Amendment Bill (as provided for in
Standing Orders);
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22.3
would repeal or remove redundant legislative provisions;
22.4
provides solely for the commencement of existing legislation or legislative
provisions;
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22.5
is solely a request to authorise spending in an Appropriation Bill or an
Imprest Supply Bill;
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22.6
is solely a request for confirmation of secondary legislation that has
already been made;
22.7
implements deeds of settlement for Treaty of Waitangi claims, other than
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those that would amend or affect existing regulatory arrangements; or
22.8
brings into effect recognition agreements under the Marine and Coastal
Area (Takutai Moana) Act 2011.
Technical exemptions available for an emergency
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23
In addition, a Regulatory Impact Statement is not required where a government
regulatory proposal is:
23.1
to make, amend, or to modify or suspend the effect of, primary or
secondary legislation, under statutory powers only able to be exercised
during a declared emergency or emergency transition period;4
4 Such as, for example, Immediate Modification Orders made in accordance with sections 14 or 15 of the
Epidemic Preparedness Act 2006.
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23.2
to do one or more of the following:
23.2.1
temporarily defer or extend legislative deadlines, or
23.2.2
provide limited temporary exemptions or modifications to
existing legislative requirements, or
23.2.3
temporarily enable alternative methods of legislative
compliance,
in situations where a declared emergency has made compliance with
existing legislative requirements impossible, impractical or unreasonably
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burdensome;
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23.3
to temporarily defer the start date of legislative requirements not yet in
force, in order to reduce burdens, or where the Government or affected
entities will no longer be ready by the planned start date, as a result of an
emergency.
Minor impacts exemption
24
A Regulatory Impact Statement is not required where the Treasury is satisfied that
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a government regulatory proposal has no or only minor impacts on businesses,
individuals or not-for-profit entities. This might, for instance, be the case for
certain changes to the internal administrative or governance arrangements of the
New Zealand government, such as the transfer of responsibilities, staff, or assets
between government agencies.
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Discretionary exemptions THE
25
A Regulatory Impact Statement may not be required where the Treasury is
satisfied that a government regulatory proposal fits within the following
situations:
25.1
the relevant issues have already been adequately addressed by existing
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impact analysis; or
25.2
a Regulatory Impact Statement would substantively duplicate other
government policy development, reporting and publication requirements or
commitments; or
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25.3
the government has limited statutory decision-making discretion or
responsibility for the content of proposed legislation;5 and
25.4
formal Impact Analysis is not the best and most cost-effective way to
ensure that Ministers have access to relevant information to inform their
decisions.
5 Such as, for example, making the minimum necessary legislative changes required to comply with
international obligations that, due to previous treaty actions, are automatically binding on New Zealand.
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26
In addition, a Regulatory Impact Statement may not be required where the
Treasury is satisfied that a government regulatory proposal, not covered by other
existing Regulatory Impact Statement exemptions, is:
26.1
intended to manage, mitigate or alleviate the short term impacts of a
declared emergency event or of the direct actions taken to protect the
public in response to a declared emergency event; and
26.2
required urgently to be effective (making a complete, robust and timely
Regulatory Impact Statement unfeasible).
27
An exemption granted under paragraphs 25 or 26 may be subject to conditions,
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such as the inclusion, provision and/or publication of some specific information,
or elements of impact analysis in an alternative form. An exemption granted
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under paragraph 26 could also depend on a commitment to include a suitable
sunset provision, and/or undertake a Post-Implementation Assessment/Review on
agreed terms and timing (see paragraphs 49 and 50). Depending on the nature of
the conditions, they may be fulfilled before or after the relevant Cabinet paper is
submitted.
Seeking an exemption
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28
Whether an “emergency technical”, “minor impacts”, or “discretionary”
exemption applies is determined by the Treasury based on: the information an
agency provides for each proposal or aspects of a proposal; the specific exemption
sought; and the agency’s reasons as to why the exemption applies. There is an
application form available for this purpose on the Treasury website.
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29
The process for exemptions sought under paragraphs 25 or 26 is likely to include
discussion between the Treasury and the agency. These discussions may include
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matters such as:
29.1
how the Impact Analysis Requirements have already been met;
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29.2
why further Impact Analysis is not the best and most cost-effective way to
provide Ministers with information relevant to their decision-making;
29.3
the extent to which the government’s decision-making discretion or
responsibility is constrained, or decisions have to be taken urgently;
29.4
the potential conditions of any exemption.
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30
Where an exemption applies, the Treasury will provide the agency with a
statement for inclusion in the relevant Cabinet paper (see paragraph 42 below).
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Content and form of Regulatory Impact Statements
31
The Regulatory Impact Statement templates tailor the form and content of the
Regulatory Impact Statement to the nature and significance of the regulatory
proposal. These templates are available on the Treasury website.
32
Unless agreed otherwise, impact analysis must be presented using the Regulatory
Impact Statement template determined by the Treasury following consideration of
information provided by the agency about its processes and the particular
regulatory proposal. Agencies must use the confirmation form available for this
purpose on the Treasury website.
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33
The Treasury may, on a case-by-case basis, agree that the agency can depart from
the Regulatory Impact Statement templates.
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34
A Regulatory Impact Statement must be signed off by a manager for the
responsible agency, and must disclose information to highlight any key gaps,
assumptions, dependencies and significant constraints, caveats or uncertainties
regarding the impact analysis.
Quality Assurance arrangements
INFORMATION
35
All Regulatory Impact Statements must also be independently quality assured
against the Quality Assurance criteria set out on the Treasury website. The
Quality Assurance criteria are the same regardless of who carries out the Quality
Assurance.
36
Quality Assurance arrangements are determined by the Treasury following
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consideration of information provided by the agency about its processes and the
particular regulatory proposal. Agencies must use the confirmation form
THE
available for this purpose on the Treasury website.
37
Whether the agency or the Treasury’s Regulatory Quality Team is responsible for
arranging Quality Assurance is determined by the Treasury based on the
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following criteria:
37.1
the agency’s policy capability and the demonstrated robustness of its in-
house quality assurance processes;
37.2
the strength of the agency’s regulatory stewardship practice in the affected
regulatory system;
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37.3
the robustness of the planned policy process;
37.4
the level of significance of the likely impacts; and
37.5
the levels of risk or uncertainty around the likely impacts.
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Document 1D
CO (20) 2
38
Where the agency is responsible for arranging Quality Assurance, the agency
must ensure it is done by a person or group not directly involved in undertaking
the impact analysis or preparing the Regulatory Impact Statement, and nominated
by the responsible agency’s Chief Executive.
39
The decision that the agency is responsible for arranging Quality Assurance is not
necessarily final. The conditions on which the decision is made are set out and
agreed with the agency. If any of the conditions change (e.g. timeframes become
compressed or the policy initiative is re-scoped) then the agency must advise the
Treasury’s Regulatory Quality Team and the decision will be reviewed.
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40
A statement by the Quality Assurance assessors on the overall quality of the
Regulatory Impact Statement must be provided in the Cabinet paper (see
paragraph 43.2 below). The quality assured Regulatory Impact Statement should
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be lodged with the Minister’s Cabinet paper.
The “Impact Analysis” section in Cabinet papers
41
Cabinet and Cabinet committee papers that contain government regulatory
proposals must contain a section entitled “Impact Analysis”.
42
If an exemption applies, this section must contain a statement from the Treasury
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confirming that the proposal, or aspects of it, is exempt from the requirement to
provide a Regulatory Impact Statement and, if relevant, any conditions of the
exemption.
43
If an exemption does not apply, this section must contain two parts, as follows:
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43.1
a statement by the responsible agency that the Impact Analysis
Requirements apply and, therefore, a Regulatory Impact Statement is
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required and is attached to the Cabinet paper; and
43.2
a statement by the Quality Assurance assessors providing an independent
assessment of the overall quality of the Regulatory Impact Statement.
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Government regulatory proposals with inadequate Impact Analysis
44
A government regulatory proposal has inadequate impact analysis if:
44.1
there is no accompanying Regulatory Impact Statement and the Treasury
has not exempted the proposal from the Impact Analysis Requirements; or
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44.2
the accompanying Regulatory Impact Statement has not been
independently quality assured, or has been assessed as “does not meet” the
Quality Assurance criteria.
45
The Chairs of Cabinet committees have discretion on whether papers containing
government regulatory proposals with inadequate impact analysis are considered.
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CO (20) 2
Supplementary Analysis Report
46
The Treasury may advise the Minister of Finance, and any other Minister with
responsibilities for the oversight and operation of the Impact Analysis
Requirements, of any government regulatory proposal with inadequate impact
analysis.
47
If a government regulatory proposal with inadequate impact analysis proceeds to
discussion at a Cabinet committee, and substantive decisions are made:
47.1
the responsible Minister must provide Cabinet with a Supplementary
Analysis Report, to be prepared by or on behalf of the relevant government
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agency, and
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47.2
the nature and timing of this report must be agreed by, or on behalf of, the
responsible Minister, and the Minister responsible for the oversight and
operation of the Impact Analysis Requirements.
48
The Supplementary Analysis Report must be Quality Assured and published along
with the original Regulatory Impact Statement (if any).
Post-Implementation Assessment/Review
INFORMATION
49
A Post-Implementation Assessment or Review6 may be required as an alternative
to the Supplementary Analysis Report in situations, such as urgency, where the
Treasury is satisfied that a Supplementary Analysis Report might not be feasible
or useful before Cabinet’s regulatory decisions are confirmed or implemented.
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50
If not already agreed by Cabinet, the nature and timing of the Post-
Implementation Assessment/Review (including whether, or what type of, quality
THE
assurance is expected) will be agreed by or on behalf of joint Ministers as for a
Supplementary Analysis Report.
Publication of Regulatory Impact Statements and Supplementary Analysis
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Reports
51
The full text7 of all Regulatory Impact Statements and Supplementary Analysis
Reports must be published on the websites of the administering agency and the
Treasury. The URLs (rather than the full text) are to be provided in the
Explanatory Note of the relevant Bill, Supplementary Order Paper, or secondary
legislation.
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52
Hard copies of Regulatory Impact Statements, and Supplementary Analysis
Reports if any, must be provided to select committees considering a Bill (or to the
House of Representatives if the Bill is to be passed under urgency).
6 A Post-Implementation Assessment/Review could range from a full review of the performance of a
regulatory change after a certain period, including whether it remains appropriate, to a more targeted or
earlier assessment of the implementation of a regulatory change to check if any adjustments are desirable.
7 Subject to any redactions that may be required to withhold sensitive or confidential information.
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CO (20) 2
53
When a Regulatory Impact Statement or Supplementary Analysis Report is ready
to be published, the agency must send for each Regulatory Impact Statement and
Supplementary Analysis Report, the agency website link and an electronic (Word)
copy to Treasury’s Regulatory Quality Team at [email address].
Further information
54
If you require further advice or information on the Impact Analysis Requirements,
please contact the Regulatory Quality Team or your Treasury Policy Team.
55
Detailed guidance on meeting the government’s Impact Analysis Requirements
and preparing a Regulatory Impact Statement is available on the Treasury’s
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website at: https://treasury.govt.nz/information-and-services/regulation/impact-
analysis-requirements-regulatory-proposals
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56
The changes set out in this circular will be reflected in due course in the
CabGuide (available on the Department of Prime Minister and Cabinet’s website
at https://dpmc.govt.nz/publications/cabguide. If you require further advice or
information about Cabinet procedures, please contact the relevant Cabinet
committee secretary.
INFORMATION
OFFICIAL
Michael Webster
Secretary of the Cabinet
THE
Enquiries:
Regulatory Quality Team at The Treasury [email address]
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Document 1E
Misuse of Drugs (Medicinal Cannabis) Regulations 2019 – Clause 35
Original 2019 Regulation
Clause 35 – Review of operation of regulations
“The Ministry must review the operation of these regulations as soon as practicable after the
expiry of the 3-year period beginning on the commencement date.”
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ACT
INFORMATION
OFFICIAL
THE
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Document 1F
Purpose, public service principles, and spirit of service to the community
11Purpose
The public service supports constitutional and democratic government, enables both the
current Government and successive governments to develop and implement their policies,
delivers high-quality and efficient public services, supports the Government to pursue the
long-term public interest, facilitates active citizenship, and acts in accordance with the law.
Compare: 1988 No 20 s 1A
12Public service principles
(1)
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In order to achieve the purpose in section 11, the
public service principles are:
Politically neutral
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(a)
to act in a politically neutral manner; and
Free and frank advice
(b)
when giving advice to Ministers, to do so in a free and frank manner; and
Merit-based appointments
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(c)
to make merit-based appointments (unless an exception applies under this Act); and
Open government
(d)
to foster a culture of open government; and
OFFICIAL
Stewardship
(e)
THE
to proactively promote stewardship of the public service, including of—
(i)
its long-term capability and its people; and
(ii)
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its institutional knowledge and information; and
(iii)
its systems and processes; and
(iv)
its assets; and
(v)
RELEASED
the legislation administered by agencies.
(2)
Public service chief executives are responsible for—
(a)
upholding the public service principles when carrying out their responsibilities and functions;
and
(b)
Document 1F
ensuring that the agencies they lead or carry out some functions within also do so.
(3)
Interdepartmental executive boards are responsible for upholding the public service
principles when carrying out their responsibilities and functions.
(4)
The boards of interdepartmental ventures are responsible for—
(a)
upholding the public service principles when carrying out their responsibilities and functions;
and
(b)
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ensuring that the interdepartmental ventures they lead also do so.
(5)
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A chief executive, an interdepartmental executive board, and a board of an interdepartmental
venture are responsible only to the Commissioner for carrying out the responsibility to
uphold the public service principles under subsections (2) to (4).
(6)
Boards of Crown agents are responsible for ensuring that the entities they govern uphold the
public service principles when carrying out their functions.
(7)
The responsibility of a board of a Crown agent under subsection (6) is a collective duty of
INFORMATION
the board under the Crown Entities Act 2004 that is owed only to the responsible Minister in
accordance with section 58 of that Act.
13Spirit of service to community
(1)
The fundamental characteristic of the public service is acting with a spirit of service to the
OFFICIAL
community.
(2)
Public service leaders, interdepartmental exe
THE cutive boards, boards of interdepartmental
ventures, and boards of Crown agents must preserve, protect, and nurture the spirit of service
to the community that public service employees bring to their work.
(3)
The responsibility of a board of a Crown agent under subsection (2) is a collective duty of
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the board under the Crown Entities Act 2004 that is owed only to the responsible Minister in
accordance with section 58 of that Act.
Subpart 3—Crown’s relationships with Māori
14Crown’s relationships with Māori
(1)
RELEASED
The role of the public service includes supporting the Crown in its relationships with Māori
under the Treaty of Waitangi (te Tiriti o Waitangi).
(2)
The public service does so by the Commissioner, public service chief executives,
interdepartmental executive boards, and boards of interdepartmental ventures having
responsibility for—
(a)
Document 1F
developing and maintaining the capability of the public service to engage with Māori and to
understand Māori perspectives:
(b)
in the employment area,—
(i)
in the case of the Commissioner, recognising the matters listed in section 73(3)(d) in the
development and implementation of the leadership strategy under section 61:
(ii)
in the cases of chief executives and boards, operating an employment policy that meets the
requirements of section 73(3)(d).
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ACT
INFORMATION
OFFICIAL
THE
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ACT
INFORMATION
OFFICIAL
THE
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Document 1G
ACT 1982
INFORMATION
s 9(2)(a)
RELEASED UNDER THE OFFICIAL
Document 2
Out of scope
From: Greg Marshall <[email address]>
Sent: Wednesday, 9 July 2025 11:23 am
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To: Christine Marsters <[email address]>; Chris James <[email address]>; Simon
Medcalf <[email address]>; Audrey Sonerson <[email address]>; Kevin Lampen-
Smith <[email address]>; Phil Knipe <[email address]>; Medicinal Can
ACT nabis
<[email address]>; Medsafe <[email address]>; Medicines Control
<[email address]>
Subject: PRE-ACTION NOTICE Advertising Guidance: Medicinal Cannabis” (July 2025) – Unlawful and Ultra Vires
PRE-ACTION NOTICE
INFORMATION
Re: “Advertising Guidance: Medicinal Cannabis” (July 2025) – Unlawful and Ultra Vires
Gregory P. Marshall LLB
OFFICIAL
SOMA Group Ltd
38 Belgrave Crescent
Dunedin 9010, New Zealand
THE
021 768 884
[email address]
9 July 2025
UNDER
BY EMAIL AND COURIER
Mr Chris James – Group Manager, Medsafe
[email address]
RELEASED vt.nz
Chief Legal Adviser – Ministry of Health – Manatū Hauora
[email address]
1. Introduction
We act for SOMA Group Ltd and a coalition of New Zealand medicinal cannabis licence holders, clinicians,
pharmacists, and patient advocates ("our clients"). We write pursuant to the Judicature Amendment Act 1972,
1
Document 2
the High Court Rules, and recognised pre-action protocol principles to formally notify the Ministry of our
intention to commence legal proceedings unless urgent remedial steps are taken.
This letter follows prior correspondence dated 8 July 2025 concerning systemic breaches of regulatory obligations.
The release of the July 2025 Advertising Guidance represents a further escalation of regulatory overreach, one
which imposes unlawful restrictions, causes immediate harm, and requires urgent legal correction.
2. Decision Under Challenge
The impugned decision is Medsafe’s publication and pending enforcement of the “Advertising Guidance:
Medicinal Cannabis” (July 2025) (“the Guidance”), which purports to prohibit or severely restrict lawful
communications well beyond the scope permitted by statute.
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ACT
3. Factual Background
a. Regulatory Context
Medicinal cannabis products verified under the Misuse of Drugs (Medicinal Cannabis)
Regulations 2019 remain “unapproved medicines” under the Medicines Act 1981.
The Guidance imposes greater restrictions than those applied to Schedule 1 controlled
INFORMATION
drugs.
No industry, clinician, or patient consultation preceded the Guidance’s release.
b. Prohibited Communications
OFFICIAL
The Guidance bans:
THE
All product names (including generic names and abbreviations such as “CBD” or “THC”);
Educational material, even to closed or opted-in patient groups;
Testimonials — even unsolicited or third-party;
References to scientific studies or peer-reviewed research;
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Pricing or availability information;
Proactive communications to health professionals.
c. Resulting Harm
Licensed producers face exclusion from the domestic market;
RELEASED
Health professionals are denied access to essential product information;
Patients are deprived of informed treatment options;
The domestic industry faces catastrophic commercial loss.
4. Legal Grounds for Challenge
Our clients will argue that the Guidance is:
2
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a. Ultra Vires the Medicines Act 1981 and Misuse of Drugs Act 1975
Neither statute authorises the blanket suppression of factual health information or
educational material;
The Guidance extends far beyond the lawful definition of “advertising” (s56, Medicines Act);
Inconsistent with Medsafe’s treatment of other unapproved or controlled medicines.
b. Adopted Without Consultation – Breaching Natural Justice
No consultation occurred despite the policy’s wide-reaching impact (Daganayasi v Minister of
Immigration [1980] 2 NZLR 130);
Industry and patient groups had a legitimate expectation of being heard;
The May 2025 inter-agency hui deliberately excluded industry and patient stakeholders.
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c. Irrational and Disproportionate (Wednesbury Unreasonableness)
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The restrictions lack a rational basis and are grossly disproportionate to any legitimate
objective;
No evidence of risk assessment, harm mitigation, or exploration of alternatives.
d. Breach of the New Zealand Bill of Rights Act 1990
Section 14 (freedom of expression): The Guidance unlawfully restricts factual and health-
related speech (Moonen v Film and Literature Board);
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Section 19 (freedom from discrimination): Cannabis patients and providers face targeted,
unjustified exclusion;
The restrictions fail the Section 5 limitation test (not demonstrably justified in a free and
democratic society).
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e. Breach of Regulatory Stewardship and Cabinet Requirements
THE
Breach of Cabinet Circular CO(20)2: No Regulatory Impact Statement or cost-benefit
analysis undertaken;
Breach of Public Service Act 2020 (ss 12–14): No assessment of public interest, equity, or
stakeholder harm;
UNDER
The Guidance is out of step with international standards, creating unnecessary trade and
information barriers.
f. Misfeasance in Public Office / Economic Tort
Available evidence suggests intentional regulatory harm and market suppression;
RELEASED
The Guidance favours offshore pharmaceutical interests over verified domestic licensees;
Estimated economic losses to the New Zealand sector exceed $60 million.
5. Legal Authorities Relied Upon
Moonen v Film and Literature Board [2000] 2 NZLR 9
Lange v Atkinson [2000] 3 NZLR 385
Daganayasi v Minister of Immigration [1980] 2 NZLR 130
3
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Associated Provincial Picture Houses v Wednesbury Corporation [1948] 1 KB 223
Council of Civil Service Unions v Minister for the Civil Service [1985] AC 374
Ririnui v Landcorp Farming Ltd [2016] NZSC 62
Vector Ltd v Transpower New Zealand Ltd [1999] 3 NZLR 646
6. Relief Sought
Immediate (by 5:00pm, 16 July 2025):
1. Suspension of the Guidance;
2. Written confirmation that no enforcement action will proceed;
3. Preservation of all internal documents relating to its development.
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Substantive Relief (If Court Proceedings Commence):
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1. Judicial review quashing the Guidance ab initio;
2. Declaration of NZBORA breaches (ss 14 and 19);
3. Mandamus requiring proper consultation and Regulatory Impact Assessment;
4. Damages for economic harm and loss of trade;
5. Indemnity costs;
6. Any further relief the Court deems just.
INFORMATION
7. Proposed Resolution
OFFICIAL
Our clients are prepared to defer litigation if the Ministry agrees, within 7 days, to:
1. Suspend the Guidance pending a revi
THE ew;
2. Confirm no enforcement action will occur under the July 2025 document;
3. Undertake full consultation including Regulatory Impact Assessment;
4. Ensure patient and industry representation in policy development;
5. Preserve all relevant documen
UNDER tation as outlined below.
8. Document Preservation Request
RELEASED
Please immediately preserve and make available (if requested) all documents, emails, memos, draft versions, and
meeting records pertaining to:
The July 2025 Advertising Guidance;
The May 2025 inter-agency hui;
Any prior decisions, advice, or consultations relating to cannabis advertising;
Communications with external agencies (including TGA, RNZCGP, or pharmaceutical
interests);
Internal legal or policy analysis.
4
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9. Consequences of Non-Compliance
If no satisfactory response is received by the stated deadline, our clients will proceed with:
1. Urgent High Court proceedings;
2. Public release of this letter and supporting materials;
3. Referral to the Chief Ombudsman and Public Service Commission;
4. Launch of a national public accountability campaign;
5. International engagement with relevant trade and human rights bodies.
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10. Contact
ACT
Should you wish to discuss resolution in good faith, please contact the undersigned.
Yours faithfully,
Gregory P. Marshall LLB
For and on behalf of SOMA Group Ltd and the Coalition of Affected Parties
INFORMATION
cc:
Hon Minister of Health
Hon Minister for Regulation
Solicitor-General
OFFICIAL
Director-General, Ministry of Health
Chief Ombudsman (for information)
THE
UNDER
RELEASED
5
Document 3
From: s 9(2)(g)(ii)
@regulation.govt.nz>
Sent: Wednesday, 16 July 2025 9:46 am
To: s 9(2)(g)(ii)
@health.govt.nz>
Cc: s 9(2)(g)(ii)
@health.govt.nz>; s 9(2)(g)(ii)
@health.govt.nz>; s 9(2)(g)(ii)
@regulation.govt.nz>
Subject: Re: Catch up request - regulatory response issue - medicinal cannabis
Great, thanks s 9(2)(g)(ii)
Thursday from 2:00pm works.
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ACT
Half an hour should be enough time, but I will book until 2:45 pm in the event we do go over.
Invite to follow.
Cheers,
INFORMATION
s 9(2)(g)(ii)
OFFICIAL
From: s 9(2)(g)(ii)
@health.govt.nz>
Sent: Tuesday, July 15, 2025 5:18 PM
To: s 9(2)(g)(ii)
@regu
THE lation.govt.nz>
Cc: s 9(2)(g)(ii)
@health.govt.nz>; s 9(2)(g)(ii)
@health.govt.nz>; s 9(2)(g)(ii)
@regulation.govt.nz>
Subject: RE: Catch up request - regulatory response issue - medicinal cannabis
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Kia oras 9(2)(g)(ii)
Thanks for your email.
RELEASED
More than happy to meet and discuss, however, both days are slightly tricky before 2pm. If you
think half an hour would be enough could do 2-2:30 on either day – I can be available until 3 if
you can make that work. (It looks like s
may potentially be available then as well.)
9(2)
Just let me know what works.
Document 3
s 9(2)(g)(ii)
s 9(2)(g)(ii)
Regulatory Practice and Analysis | Medsafe | Ministry of Health | s 9(2)
@health.govt.nz
(g)(ii)
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From: s 9(2)(g)(ii)
@regulation.govt.nz>
ACT
Sent: Tuesday, July 15, 2025 10:58 AM
To: s 9(2)(g)(ii)
@health.govt.nz>
Cc: s 9(2)(g)(ii)
@health.govt.nz>; s 9(2)(g)(ii)
@health.govt.nz>; s 9(2)(g)(ii)
@regulation.govt.nz>
Subject: Catch up request - regulatory response issue - medicinal cannabis
Kia ora s 9(2)(g)(ii)
INFORMATION
It was lovely to meet you recently, and I hope you have been having a good week so far.
OFFICIAL
As you may be aware, the Ministry for Regulation has an online 'red tape portal' which has been
open since November last year. We have received over 800 submissions since then.
THE
One of the issues received through the portal that we are looking into - is to do with the Misue of
Drugs (Medicinal Cannabis) Regulation 2019 (Medicinal Cannabis Regulations).
UNDER
We recently got in touch with the submitter to understand more about the specific regulations
they think are problematic. Those that they identified are:
1. Security requirements
2. Stability requirements
RELEASED
3. Three batch testing
4. Definition of starting material and cannabis-based ingredient and the associated
requirements on the manufacturer or testing laboratory
To support my understanding, I was hoping to line up a meeting with you (this week if possible)
to have a chat. I have a couple of technical questions around those requirements and would
Document 3
also like to understand a bit more about the recent changes to the Medicinal Cannabis
Regulations and how those were received.
Please note that the submitter has informed us of a ‘pre-action notice’ that was sent through to
Health officials in relation to the July 2025 Advertising Guidance for Medicinal Cannabis. To
confirm, we do not intend to have any role in relation to this notice but are happy to discuss any
helpful ways we can share information on respective projects.
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Our availability is:
Thursday 17 July: any time from 12:00 to 2:30 pm
ACT
Friday 18 July: 1:00 – 2:00 pm or 1:30 - 2:30
Please let me know if any of these times work for you.
Thank you kindly,
INFORMATION
s 9(2)(g)(ii)
s 9(2)(g)(ii)
OFFICIAL
Reviews and System Capability
Ministry for Regulation
THE
īmēra: s 9(2)(g)(ii)
@regulation.govt.nz
UNDER
RELEASED
www.regulation.govt.nz
..........................................................................................................................................
Confidentiality notice: This email may be confidential or legally privileged. If you have received it
by mistake, please tell the sender immediately by reply, remove this email and the reply from
your system, and don’t act on it in any other way. Ngā mihi.
Document 3
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
..........................................................................................................................................
Confidentiality notice: This email may be confidential or legally privileged. If you have received it
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by mistake, please tell the sender immediately by reply, remove this email and the reply from
your system, and don’t act on it in any other way. Ngā mihi.
ACT
INFORMATION
OFFICIAL
THE
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