133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
B Haddock
By email: [FYI request #14043 email]
Ref:
H202007996
Dear B Haddock
Response to your request for official information Thank you for your request under the Official Information Act 1982 (the Act) on 27 October 2020
for:
“I understand that various medicinal cannabis products are currently undergoing reviews to
become approved medicines. This includes MediPharm Labs products, which Helius
Therapeutics Ltd and Cannasouth Ltd have entered in to supply agreements for.
Can you please supply a list of products that:
1. Have been considered for approval as approved medicines, with a final outcome
decided.
2. Were not considered for approval as approved medicines, as they did not meet basic or
qualifying criteria.
3. Are currently under consideration for approval as approved medicines.”
Firstly, for clarification, assessment of medicinal cannabis products by the Medicinal Cannabis
Agency (the Agency) for verification against the minimum quality standard is completely different
from consent for distribution or ‘approval’ of medicines under the Medicines Act 1981.
Approved medicines have been assessed by Medsafe for safety and efficacy for their approved
indications, in addition to assessment of their quality. Sativex™ is currently the only medicinal
cannabis product that is an ‘approved medicine’ under the
Medicines Act 1981
Under the New Zealand Medicinal Cannabis Scheme, medicinal cannabis products and
ingredients must be verified by the Agency as meeting the minimum quality standard which is set
in Part 1 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019, and licensed for supply.
Medicinal cannabis products that are verified by the Agency as complying with the minimum
quality standard are not approved medicines under the Medicines Act 1981 but remain
unapproved medicines.
Medicinal cannabis products that are approved (such as Sativex™) or provisionally approved
under the Medicines Act 1981 are not required to meet the minimum quality standard as they will
have already been assessed and approved.
Information in response to each part of your request is provided below regarding applications
received by the Agency for assessment and verification of medicinal cannabis products and
ingredients against the minimum quality standard, rather than approval as medicines under the
Medicines Act 1981. A new medicinal cannabis product application is considered to be formally
accepted for assessment once the application has passed an initial check for completeness and
the Agency has received payment of the product assessment fee.
“1. Have been considered for approval as approved medicines, with a final outcome decided.”
To date, no medicinal cannabis product applications formally accepted for assessment by the
Medicinal Cannabis Agency have reached the point where a recommendation can be made to
the Director-General of Health, to be verified as complying with the minimum quality standard.
“2. Were not considered for approval as approved medicines, as they did not meet basic or
qualifying criteria.”
To date, five applications for assessment of medicinal cannabis products have been received by
the Medicinal Cannabis Agency that have not been formally accepted for assessment against the
minimum quality standard as they did not pass an initial check for completeness.
“3. Are currently under consideration for approval as approved medicines.”
To date, nine applications for medicinal cannabis products and ingredients have been formally
accepted for assessment against the minimum quality standards and are currently under
assessment. The products are tabulated in Table One below, for your information.
Table One: Medicinal Cannabis products currently under assessment
Proposed product name
Type of product
Tilray FS Oral Solution THC 1: CBD 25
Dosage product
Tilray FS Oral Solution THC 25
Dosage product
Tilray FS Oral Solution THC 2: CBD 100
Dosage product
Tilray P Oral solution CBD 25
Dosage product
Tilray P Oral Solutions CBD 100
Dosage product
Tilray FS Oral Solution THC 10: CBD 10
Dosage product
Tilray FS Oral Solution THC 5: CBD 20
Dosage product
Tilray CBD crystal
Cannabis-based ingredient
ANTG Eve
Dried product
Also, to date, seven applications for assessment of medicinal cannabis products have been
received that are undergoing an initial check for completeness before a decision is made as to
whether they can be formally accepted for assessment.
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At present, the Agency is unable to provide an estimate of when any product or ingredient will be
verified as complying with the minimum quality standard as the applications are currently under
assessment. Under normal circumstances, we would expect an application could take up to 60
working days from acceptance of the application for assessment through to verification against
the minimum quality standard. This includes time for the Agency to assess the application and to
request further information or analytical results, and assess any further information provided.
However, there are many factors which will influence this time frame, including the quality of the
information provided in the application, the ability of the applicant to demonstrate that they meet
the requirements of the legislation, and the time taken for the applicant to respond to the
Agency’s request for further information.
I trust this information fulfils your request. 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. Yours sincerely
Chris James
Group Manager
Medsafe
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