133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
19 January 2024
Nikau W
By email: [FYI request #24970 email]
Ref:
H2023033298
Tēnā koe Nikau
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Hauora
(the Ministry of Health) on 1 December 2024 for information regarding medicinal cannabis. You
requested:
“
I hear you have recommendations for the govt around medical cannabis law. Can you
share any of the documents you have related to that and what those recommendations
are.”
On 17 January 2024, the Ministry contacted you to clarify what specific information you are
seeking regarding recommendations for the government around the medicinal cannabis law.
Your clarified request, received on 19 January 2024, is copied and responded to below.
1. Any and all briefings to the incoming minister of health that pretain in any way to
medicinal cannabis.
The Ministry has identified one mention of medicinal cannabis in the Briefing to the Incoming
Minister (BIM). This is in Appendix A of the BIM outlining upcoming decisions in early 2024
within the health portfolio.
The Cabinet Paper (Legislation Committee): Amendments to the Misuse of Drugs (Medicinal
Cannabis) Regulations 2019 is listed with a timeframe for decision being February 2024.
No other documents or communications from the Ministry to the Minister of Health have been
identified. The full BIM wil soon be proactively released on the Ministry’s website at:
www.health.govt.nz/about-ministry/information-releases in accordance with section 18(d) of the
Act.
2.the current draft of new regulations
The current draft of the amendment regulations are withheld under section 9(2)(g)(i) of the Act
to maintain the effective conduct of public affairs through the free and frank expression of
opinions by or between or to Ministers of the Crown or employees of any public service agency.
A final draft may be available for release at a later date.
3.the application to treasury for exemption from regulatory impact analysis of proposed
changes to medicinal cannabis regime.
The requested document is appended to this letter and has been released to you in full.
4. Any and all briefings or recommendations provided to the minister of health and or
cabinet pertaining to medical cannabis for the period may 20th 2023 until october 1st
2023.
This information is publicly available on the Ministry of Health website here:
www.health.govt.nz/about-ministry/information-releases/release-ministerial-decision-making-
documents/cabinet-material-improving-medicinal-cannabis-scheme-better-support-economic-
and-research. Copies of the proactively released Cabinet material, on ‘Improving the Medicinal
Cannabis Scheme to better support economic and research opportunities’ can be downloaded
from this page.
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
Manatū Hauora website at
: www.health.govt.nz/about-ministry/information-releases/responses-
official-information-act-requests.
Nāku noa, nā
Derek Fitzgerald
Licensing Authority
Medicinal Cannabis Agency
Page 2 of 2
Appendix 1
Proposed changes to the Misuse of Drugs (Medicinal Cannabis) Regulations 2019
Proposed change
Description
Exemption ground
Exemption rationale
1 Clarifying what ‘ingredient’
‘ingredient’ refers to
Technical clarification to active
• Minor impact expected for businesses
and ‘product’ refer to in the active ingredient and
ingredient definition in the Misuse
and individuals.
active ingredient definition.
‘product’ refers to
of Drugs (Medicinal Cannabis)
• No expected financial impact.
medicinal cannabis
Regulations 2019 (the Regulations)
product.
to improve clarity.
2 Clarifying starting material
‘starting material’ is
Technical clarification to the
• Minor impact expected for businesses
interpretation to provide
intended to be further
starting material definition in the
and individuals.
clarity for when cannabis is
processed.
Regulations to improve clarity.
• No expected financial impact.
considered either starting
material or a medicinal
cannabis product.
3 Allow medical practitioners
Aligns with section 25 of Technical adjustment which
• More enabling to align with section 25 of
to import medicinal cannabis the Medicines Act 1981 provides for alignment with
the Medicines Act 1981.
products that do not meet
which allows medical
existing legislative provisions under
• Minor impact expected on businesses
the minimum quality
practitioners to import
the Medicines Act 1981.
and individuals and only confers benefits
standard for named
unapproved medicines
to medical practitioners who are involved
patients.
for a named patient.
in importing medicines.
• Aligning with provisions currently allowed
under section
under the Official Information Act 1982 25 of the Medicines Act
1981.
4 Exempt testing of container In some situations,
Technical adjustment to the
• This current requirement is inconsistent
material, excipients, and
cannabis-based
minimum quality standard.
with the regulation of other medicines
other ingredients to be
ingredients are not
and expected practice.
carried out at a Good
being sold or
• Minor impact expected for businesses
Manufacturing Practice
distributed. It is
Released
and individuals.
reasonable for
Appendix 1
(GMP)-certified
container material
• Confers only benefits to industry who
manufacturer or laboratory. requirements to not
conduct testing.
apply.
• No financial impacts expected.
5 Allow non-critical tests to be Better reflects the
Technical amendment to change
• This does not impact on the overal
completed at ISO/IEC 17025 laboratory testing
the laboratory accreditation
quality of products supplied to New
(ISO) accredited sites instead capabilities in New
requirements for some testing to
Zealand patients.
of being required to be
Zealand to support local better reflect New Zealand testing
• This better supports the domestic
completed at a GMP
products entering the
capability.
production of cannabis-based ingredients
manufacturer or GMP
domestic market.
laboratory only.
and medicinal cannabis products.
• Confers benefits to industry and no
financial impacts expected.
6 Amend the labelling
Clarify that controlled
Technical adjustment to improve
• Minor impact on businesses and
requirements to include a
drug classification
the clarity of the Regulations.
individuals, as this is a descriptive change
reference to the Misuse of
statements take
outlining what the current legislative
Drugs Regulations 1977.
precedence over
provisions should be.
classification
statements required
under the Medicines
Regulations 1984.
7 Expressly state in the
Better clarifies the
Minor technical change to provide
• Minor impact on businesses and
Regulations that possession intent of this regulation. clarity and ensure consistency
individuals.
of cannabis is allowed only
between the objectives of the
for the purposes of
Regulations and the required
performing licensed
activities enabled to achieve these
activities.
objectives.
under the Official Information Act 1982
8 Remove the reference to
Helps better reflect the This is a technical change to clarify
• The research activity was intended for
producing or manufacturing intent of research
the purpose of this activity.
clinical trials only.
a cannabis-based ingredient activity – for the
• Minor impact expected for businesses
or medicinal cannabis
purpose of clinical trials.
and individuals.
product under a medicinal
This function is already
Released
• No financial impacts expected.
enabled under a
Appendix 1
cannabis licence with a
possession for
• There is currently no medicinal cannabis
research activity.
manufacture activity,
licence holder with a research activity.
which is the more
Any research relating to producing or
appropriate
manufacturing a cannabis-based
authorisation.
ingredient is already enabled under a
different licensed activity (possession for
manufacture).
9 Include testing of starting
The activity allows for
Technical adjustment to a licensed
• The activity currently allows for testing of
material and cannabis-based testing of cannabis and activity to clarify the activities
cannabis and medicinal cannabis
ingredients under a
medicinal cannabis
enabled and required under the
products but not the intermediate step
possession for manufacture products already. It is
Regulations for testing and
(the cannabis-based ingredient).
activity.
reasonable to extend
validation of cannabis-based
• Allows for commencement of required
this to starting material ingredients.
legislative provisions.
and cannabis-based
• Net benefit to industry expected, with
ingredients.
only minor impacts to business and
individuals.
10 Testing wil be expressly
Testing is an important Minor technical change to clarify
• Provides clarity to the current allowable
stated as an allowable
aspect of product
the purpose of the possess for
activities under the Regulations.
activity under the possession development. It is
manufacture activity.
• Net benefits expected, minor impacts to
for manufacture licence.
currently listed as a
businesses and individuals.
permitted activity but
not as a ‘purpose’. This
change is intended to
improve clarity of what
this activity is intended
under the Official Information Act 1982
for.
11 Provide greater flexibility to Remove an identified
Technical adjustment to regulation
• This has been identified as overly
the type of documents
barrier (only accepting
32.
restrictive and is more of an
applicants can provide to
standard operating
administrative change which will increase
support their applications
procedures) and enable
options for applicants.
for a licence, whilst still
other appropriate
• Minor impacts expected to businesses
requiring that adequate
administrative
Released
and individuals.
arrangements be made to
documentation (eg,
Appendix 1
prevent risk of misuse for an procedures or
unlawful purpose.
operations manuals) in
applications for
medicinal cannabis
licences under the
Regulations.
13 Amend the dosage product
The current dosage
Minor technical adjustment which
• Provides clarity of fees for industry,
assessment fee to be
assessment fee in the
provides for alignment with
confers net benefits only.
consistent with the
Regulations is $13,400
existing legislative provisions.
• Minor impact on businesses and
assessment fees for
excluding GST. This
individuals.
cannabis-based ingredients
includes an assessment
•
and dried products.
for cannabis-based
Minor change to internal administrative
ingredients and the final
processes.
dosage products. Most
• Corrects a drafting error.
manufacturers are using
the same cannabis-
based ingredient for
multiple dosage
products. The fee for a
dosage product should
only reflect the
assessment of the
dosage product only.
14 Providing clarification on
Better clarifies intent of Minor technical change to improve
• Minor impact on business and
recording requirements for
this regulation.
the clarity of existing legislative
individuals.
cultivation.
Confusion regarding
provisions.
under the Official Information Act 1982
• No expected financial impact.
who ‘holder of a
licence’ refers to in this
regulation.
15 Clarify that licence holders
Better clarifies intent of Minor technical change to improve
• Minor impact on businesses and
must keep records for any
this regulation,
Released
the clarity of existing legislative
individuals.
destruction of material
including requirements provisions.
• No expected financial impact.
Appendix 1
under a nursery, research,
that destroyed material
possession for manufacture also needs to be
and supply activity
recorded.
16 Update the date for
Ensures consistency
Technical amendment to remove
• Align with requirements under regulation
reporting of stocktakes
between legislation.
legislative provision which is
49A the Misuse of Drugs Regulations
consistent with other
inconsistent with the treatment of
1977 (31 December) for the stocktake of
controlled drug legislation.
all other controlled drugs.
control ed drugs.
• Minor impacts on businesses and
individuals.
• Minor change to internal administrative
processes.
• No expected financial impact.
17 Include a new regulation to
These requirements
Clarifying an area of current
• Providing clarification for the advertising
reference the Misuse of
also apply to medicinal
legislation.
requirements under regulation 50 the
Drugs Regulations 1977
cannabis licence
Misuse of Drugs Regulations 1977.
advertising of controlled
holders. This will clarify
• Minor impact on businesses and
drug requirements.
the application.
individuals.
• No expected financial impact.
18 Provide clarification for
The minimum quality
Providing clarification for the
• Aligning with the purpose and objectives
when the minimum quality
standard only applies
intention and implementation of
of the Medicinal Cannabis Scheme.
standard only applies to CBD where the active
the current legislation.
• More enabling for industry as they
products
ingredients and
understand what is and isn’t captured
cannabinoids originate
under the Scheme.
from cannabis and the
under the Official Information Act 1982
CBD product is intended
• Minor impact on businesses and
for a therapeutic use.
individuals.
19 Prohibit personal
Clarifies the intent of
Provides for alignment with
• Aligning with the purpose and objectives
importation of CBD products regulation 4A of the
existing legislative provisions on
of the Medicinal Cannabis Scheme to
Released
for personal use via mail or
Medicines Regulations
CBD products.
courier.
Appendix 1
ensure there is consistent regulation of
CBD products in New Zealand.
• Minor impact on businesses and
individuals.
• No expected financial impact.
20 Allow travellers entering
Ensure that lawfully
Adjustment to remove unintended
• Aligning and ensuring consistent
New Zealand to import CBD supplied CBD products
restrictive legislative provision.
regulation of all prescription medicines
products on their person if it are permitted for
under the Medicines Regulations 1984
has been lawful y supplied
travellers like other
which are being lawfully imported into
and the quantity does not
prescription medicines.
New Zealand.
exceed a 3 month supply.
• Clarifies activities currently enabled
under the law for all CBD products.
• Minor impact on businesses and
individuals.
• No expected financial impact.
21 Enable CBD products to be
Al ow CBD products to
Unnecessary barrier identified; this
• The current regulation states that these 2
named on appropriate
be named on a licence
change ensures consistency with
licences do not apply to CBD products
licences.
to manufacture
the objectives of the Regulations.
unless they meet the minimum quality
medicines and a licence
standard. However, a manufacturer
to pack medicines if
needs these licences to manufacture the
they have not been
CBD products in the first place. The
verified as meeting the
minimum quality
current regulation is not operationally
standard. However, if
sensible and is not functioning as
under the Official Information Act 1982
they are required to
intended.
meet the minimum
• Minor change to internal administrative
quality standard, then
processes.
supply would stil be
• Minor impact on businesses and
prohibited unless the
individuals.
product is either
• No expected financial impact.
verified, or being
Released
Appendix 1
supplied as part of an
approved clinical trial.
22 Enable licences to operate a Allow licences to
Technical adjustment to improve
• This addresses a conflicting legislative
pharmacy to supply products operate a pharmacy to
the operations of the Regulations.
provision impacting what can be supplied
verified under the Scheme.
supply cannabis-derived
on a pharmacy licence, which has been
CBD products which
identified as a barrier.
have been verified
• Confers net benefits only.
against the minimum
quality standard,
• No expected financial impact.
received consent for
distribution under the
Medicines Act 1981 or
are imported and
supplied pursuant to a
prescription by a
medical practitioner for
a named patient.
23 Allow some flexibility for
Better reflect what can Minor technical adjustment within
• Improves clarity and the workability of
manufacturers in
be reasonably
the minimum quality standard of
the requirements for industry.
determining assay limits for
control ed in the
the Regulations.
• Minor impact on businesses and
active ingredients.
manufacturing process.
individuals.
The current regulation
• No expected financial impact.
is difficult to achieve,
too restrictive in some
circumstances and not
appropriate for broad
under the Official Information Act 1982
spectrum cannabis-
based ingredients.
24 Clarify that manufacturers
The container material
Technical adjustment within the
• Aligns container material requirements
are exempt from complying
requirements apply only minimum quality standard.
with manufacturing requirements for
with container material
when a cannabis-based
other pharmaceutical products produced
requirements if their
ingredient is sold
Released and
under the Medicines Act 1981.
cannabis-based ingredient is distributed.
Appendix 1
being stored in a
• Net benefits only.
manufacturing facility for
This proposal will also
• Minor impact on businesses and
manufacturing into
broaden the types of
individuals.
products.
material that would be
• No expected financial impact.
acceptable packaging
(ie, food safe packaging)
to better align with how
this requirement is
managed for other
medicines.
25 Al ow the use of excipients
Better aligns with
A technical adjustment to improve
• Enable more options in excipients
with monographs from the
requirements expected the workability of the Scheme.
al owed to be used in the production of
British Pharmacopoeia,
for other medicines and
finished products.
United States
allows manufacturers to
• Net benefits for industry.
Pharmacopoeia and
use a broader range of
• Minor impact on businesses and
Japanese Pharmacopoeia in materials.
dosage products.
individuals.
• No expected financial impact.
26 Allow manufacturers to
The current regulation
Technical change to clarify
• The minimum quality standard specifies
determine when some
requires some testing to requirements under the minimum
tests that must be completed for a
testing for cannabis-based
be completed in both
quality standard.
cannabis-based ingredient and a
ingredients and medicinal
the cannabis-based
medicinal cannabis product. Some of
cannabis products is
ingredient and
these tests are for the same parameters
completed.
medicinal cannabis
and manufacturers are having to perform
product. In some
circumstances, it is
the same test twice. This amendment will
under the Official Information Act 1982
appropriate for this
allow manufacturers to only perform
testing to be completed
some tests once depending on the best
at only one stage. This
stage that the parameter can be
will help streamline
managed. There is no regulatory benefit
compliance and testing
of having the same tests performed
costs.
twice.
Released
• Net benefits for industry.
Appendix 1
• Technical change to the minimum quality
standard itself.
• Minor impact on businesses and
individuals.
• No expected financial impact.
27 Amend regulation 18 to
The current regulation
Technical change to the minimum
• Enables the current regulation to
include a list or criteria for
managing pesticides
quality standard proposed.
function as intended to manage the risk
pesticides that can be
permitted to be used on
of pesticide contamination in medicinal
permitted to be used on
cannabis crops is
cannabis products.
cannabis crops.
unworkable and
• Regulation 18 which controls the use of
effectively prohibits use
of any pesticides on
pesticides for medicinal cannabis is
these crops.
currently unworkable. The regulation
needs to be amended to update the
requirements to regulate which
pesticides can be used on cannabis crops.
• Net benefits for industry.
• Minor impact on businesses and
individuals.
• No expected financial impact.
28 Allow inclusion of further
Increase the range of
Technical change to the minimum
• Enables a broader range of test methods
tests, test methods and
tests permitted under
quality standard.
that can be used by industry to test the
limits to be included into the the Regulations where
quality of their products.
minimum quality standard.
appropriate.
• The current minimum quality standard
specifies which tests and test methods
under the Official Information Act 1982
that must be completed.
• Improves the workability of the
regulations.
• Net benefits for industry.
• Minor impact on businesses and
individuals.
Released
• No expected financial impact.
Appendix 1
29 Al ow CBD products that
Regulation 45B
This proposal is a technical change
• The current regulations exempt CBD
have received ministerial
unintentionally
to allow the regulation to function
products that have received ministerial
consent to be expressly
prevents the supply of
as intended.
consent from needing to meet the
authorised on licences.
consented CBD
minimum quality standard. However,
products.
another regulation requires that ONLY
CBD products which have been assessed
CBD products which
have received
as meeting the minimum quality standard
ministerial consent do
can be authorised on a licence.
not need to meet the
• Improves the workability of the
minimum quality
regulations.
standard.
• Net benefits to industry.
However, this conflicts
• Minor impact on businesses and
with regulation 45B
individuals.
which requires only CBD
• No expected financial impact.
products that have met
the minimum quality
standard to be
authorised on licences.
30 Update the referenced
The 10.0 edition of the
Technical change.
• Update the version of the European
European Pharmacopoeia in European
Pharmacopoeia for tests in the minimum
the Regulations.
Pharmacopoeia
quality standard. The version in the
referenced in the
Regulations has been superseded.
Medicinal Cannabis
• Improves the workability of the
Regulations has been
superseded.
regulations.
under the Official Information Act 1982
• Net benefits for industry.
• Minor impact on business and
individuals.
• No expected financial impacts.
31 Clarify that CBD products
Aligns the regulation of Technical change to align with the
• Unapproved medicines do not need their
intended for clinical trials do CBD products with
regulation of clinical trials.
Released
quality verified before being used in a
not need to be verified as
regulation on other
clinical trial.
Appendix 1
meeting the minimum
medicines carried by
• Minor impact on business and
quality standard.
travellers and used in
individuals.
clinical trials, as per the
• No expected financial impact.
Medicines Act 1981.
32 Clarify that the minimum
Allow exports of
Technical change to clarify the
• The minimum quality standard
quality standard only applies starting material that do applicability of the minimum
requirement is currently applied to all
to goods being exported for not meet the minimum quality standard.
exports of starting material, cannabis-
therapeutic end use.
quality standard on a
based ingredients and medicinal cannabis
cultivation or
products regardless of the intent of
possession for
export. This is a barrier for local
manufacture activity for
the purposes of testing,
cultivators and manufacturers wishing to
analysis and research.
access testing, analysis, manufacturing
and research services overseas and not
Allow exports of
proportionate to level of risk.
starting material,
• Change will benefit licence holders and
cannabis-based
allow the Scheme to function as
ingredients and
intended. Currently, there are limited
medicinal cannabis
testing and manufacturing facilities in
products that do not
New Zealand. Companies need to access
meet the minimum
overseas facilities in order to complete
quality standard by a
testing and manufacturing so products
holder of a medicinal
can be verified as meeting the minimum
cannabis licence with a
supply activity for the
quality standard.
under the Official Information Act 1982
purposes of testing,
• Minor impact on business and
analysis, manufacturing
individuals.
or research.
• No financial impact expected.
33 Allow medicinal cannabis
Broaden the materials
Aligns with how cannabis seed can
• Minor impact of business and individuals.
seed to be exported on a
that can be expo
Released rted be supplied domesticaly under the
Confers only benefits to those in working
under the framework.
Appendix 1
cultivation or nursery
under the medicinal
Scheme and exported under the
• The licensing framework already enables
activity.
cannabis scheme.
Misuse of Drugs Regulations 1977.
export of medicinal cannabis. This
expands the types of material that can be
Currently cannabis seed
exported.
can be supplied
• No financial impact expected.
domestical y but cannot
be exported under a
medicinal cannabis
licence.
34 Re-defining scope of nursery This will remove any
Technical change to the regulation
• The Medicinal Cannabis Agency has only
activity to procurement and reference to import and to clarify scope of the activity.
issued this activity for seed supply
supply of cannabis seed
supply of cannabis
purposes.
only.
plant.
• Minor impact on business and
This will clarify the
individuals.
intent of the activity.
Import and supply of
• No financial impact expected.
cannabis plant should
be authorised under a
“cultivation” activity
which is the most
appropriate
authorisation for this
activity.
35 Remove “to produce or
This will clarify that the Technical change to clarify the
• There is currently no issued research
manufacture a cannabis-
intention of the activity intent of the research activity
licence so this
under the Official Information Act 1982 change will not affect
based ingredient or
is for clinical trials. This under a medicinal cannabis licence.
current licence holders.
medicinal cannabis product” activity is already
• Minor impact on business and
as a permitted activity under permitted under a
individuals.
a research activity.
“possession for
manufacture” activity
• No expected financial impact.
which is the mos
Released t
appropriate
Appendix 1
authorisation for this
purpose.
36 Broadening the types of
The current permitted
Improving the definitions to better
• Minor impact on businesses and
plant forms that can be
plants forms are
align with the manufacturing
individuals.
considered ‘starting
restrictive and not
process for cannabis-based
• Confers only benefits to affected industry
material’ and ‘cannabis-
consistent with the
ingredients and medicinal cannabis
stakeholders.
based ingredients’
types of plant forms (eg, products.
• No financial impacts expected.
dried cannabis or
extracts of cannabis)
that can be used in the
manufacturing process.
If change is agreed to,
the minimum quality
standard wil need to be
updated to specify the
testing requirements to
address any quality risks
for when dried cannabis
is used as a cannabis-
based ingredient.
37 Allow import of material
The minimum quality
Technical change to address barrier
• Confers net benefits only and will allow
that does not meet the
standard is currently
identified for research activities.
for greater range of research activities to
minimum quality standard
applied to imports of
be undertaken domestical y.
for the purpose of research. material that does not
• Minor impact on businesses and
meet the minimum
under the Official Information Act 1982
individuals.
quality standard even
though the imports are
• No expected financial impact.
intended for analysis
and research purposes
and not for therapeutic
use. This will clarify the
Released
application of the
Appendix 1
minimum quality
standard to these
imports.
38 Allow a licence to possess
Correct a gap in the
Technical change to address
• Provides only benefits.
control ed drugs be issued
licensing framework to
barriers identified for research
• Minor impact on business and
for cannabis grown under
allow non-therapeutic
activities al owed under the
individuals.
the Scheme, starting
research to occur with
Regulations.
• No financial impacts expected.
material, cannabis-based
domestically sourced
ingredients, medicinal
cannabis. The pathway
cannabis products and
was removed in the
industrial hemp. Allow
drafting of the
medicinal cannabis and
Regulations to provide
industrial hemp to be
distinction in the
supplied to holders of a
regulatory frameworks
licence to possess.
that oversees cannabis
activities in New
Zealand. It is now clear
that it is acting as a
barrier for cannabis-
based research to occur
in New Zealand.
Proposal will reinstate a
licensing pathway for
these activities as it will
allow researchers to
access domestically
under the Official Information Act 1982
grown material instead
of sourcing from
overseas or growing
their own.
39 Custody of control ed drug
Requirements for the
Clarifying an area of current
• Providing clarification for the application
requirements.
custody of contr
Released oled legislation.
of custody of control ed drug
drugs also apply to
Appendix 1
medicinal cannabis
requirements under regulation 28 the
licence holders.
Misuse of Drugs Regulations 1977.
• Minor impact on businesses and
individuals.
• No expected financial impact.
under the Official Information Act 1982
Released
