Overview of Medicinal Cannabis Scheme and CBD Products in New Zealand
The Medicinal Cannabis Scheme and
CBD products
Vidhiya Damodaran
Purpose of the Medicinal Cannabis Scheme
•
Sets up a licensing
regime that allows
for manufacture
and supply of
medicinal cannabis
products in NZ
•
Reduces barriers to
prescribing
products
To improve
access to
quality
medicinal
cannabis
products for
patients
Minimum Quality Standard
•
To ensure the consistency and quality of the
products that medical practitioners prescribe to
patients.
•
There are three broad categories for meeting
the minimum quality standard:
•
requirements for testing with maximum limits
•
restrictions and controls on products
•
testing and validation of testing method.
•
https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-
cannabis-agency/medicinal-cannabis-agency-information-industry/medicinal-cannabis-
agency-working-medicinal-cannabis/medicinal-cannabis-agency-minimum-quality-standard
Access to Medicinal Cannabis
•
Access via a prescription
from a medical practitioner
under section 29 of
Medicines Act
•
Ministerial approval to
prescribe no longer
required for products
meeting QS
•
Can be prescribed by GP
•
List of products assessed
against the QS will be made
available
Prescription
medicine and
a controlled
drug
CBD products are
prescription medicines only
Restrictions (controlled drug)
•
Products cannot be labelled with a clinical
indication
•
Products cannot be advertised
•
Must be naturally derived from cannabis (no
synthetic)
•
Must be labelled “Medicinal Cannabis Product”
Exemptions (controlled drug)
•
Exempt from meeting the QS when:
•
a consented or provisionally consented medicine
•
for a clinical trial
•
prescribed for a named patient (still requires
Ministerial approval for controlled drugs)
•
imported by a pharmacist pursuant to a
prescription meeting above requirements
CBD Product definition
(
a) contains cannabidiol; and
(b) either—
(i) does not contain a specified substance;
or
(ii) contains specified substances in an
amount that is no more than 2% of the
sum of the amount of cannabidiol and the
amount of specified substances in the
product; and
(c) does not contain any other
controlled drug; and
(d) does not contain any other
psychoactive substance
specified substance
means a
substance that—
(a) naturally occurs in cannabis; and
(b) is—
(i) a tetrahydrocannabinol; or
(ii) an isomer, ester, or ether of a
tetrahydrocannabinol; or
(iii) an ester or ether of an isomer of a
tetrahydrocannabinol; or
(iv) a salt of any substance described in
subparagraphs (i) to (iii); or
(v) a substance that has a structure
substantially similar to that of any
substance described in subparagraphs (i)
to (iv); and
(c) for substances listed in paragraph
(b)(ii) to (v), is capable of inducing
more than a minor psychoactive
effect, by any means, in a person.
Access to CBD products
•
Access via a
prescription from a
medical practitioner
under section 29 of
Medicines Act
•
Can be prescribed by
GP
•
List of products
assessed against the
QS will be made
available
CBD is a
prescription
medicine
only
Restrictions and exemptions
•
Products cannot be labelled with a clinical
indication
•
Products cannot be advertised
•
Must be labelled “Medicinal Cannabis Product”
•
Can be synthetic or naturally derived
•
Exempt from meeting the QS when:
•
a consented or provisionally consented medicine
•
for a clinical trial
•
prescribed for a named patient
•
imported by a pharmacist pursuant to a
prescription for a named patient.
How products are controlled
•
Quality standards imposed on products via licences
•
QS apply to
:
•
Starting material for export
•
Cannabis-based ingredients
•
Medicinal cannabis products
•
Medicinal cannabis product can be a “dried
product” or “dosage product”
•
6-month transition period for products already
being prescribed to meet QS
The Medicinal Cannabis Scheme in New Zealand aims to improve access to quality medicinal cannabis products for patients by setting up a licensing regime for manufacture and supply. It establishes minimum quality standards to ensure consistency and quality of prescribed products. Access to medicinal cannabis is through prescription by medical practitioners, with exemptions for specific situations. Controlled drug restrictions and exemptions are in place, with CBD products defined as specified substances naturally occurring in cannabis. For more details, visit the provided links.
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Presentation Transcript
The Medicinal Cannabis Scheme and CBD products Vidhiya Damodaran
Purpose of the Medicinal Cannabis Scheme Sets up a licensing regime that allows for manufacture and supply of medicinal cannabis products in NZ Reduces barriers to prescribing products To improve access to quality medicinal cannabis products for patients
Minimum Quality Standard To ensure the consistency and quality of the products that medical practitioners prescribe to patients. There are three broad categories for meeting the minimum quality standard: requirements for testing with maximum limits restrictions and controls on products testing and validation of testing method. https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal- cannabis-agency/medicinal-cannabis-agency-information-industry/medicinal-cannabis- agency-working-medicinal-cannabis/medicinal-cannabis-agency-minimum-quality-standard
Access to Medicinal Cannabis Access via a prescription from a medical practitioner under section 29 of Medicines Act Ministerial approval to prescribe no longer required for products meeting QS Can be prescribed by GP List of products assessed against the QS will be made available Prescription medicine and a controlled drug CBD products are prescription medicines only
Restrictions (controlled drug) Products cannot be labelled with a clinical indication Products cannot be advertised Must be naturally derived from cannabis (no synthetic) Must be labelled Medicinal Cannabis Product
Exemptions (controlled drug) Exempt from meeting the QS when: a consented or provisionally consented medicine for a clinical trial prescribed for a named patient (still requires Ministerial approval for controlled drugs) imported by a pharmacist pursuant to a prescription meeting above requirements
CBD Product definition specified substance means a substance that (a) naturally occurs in cannabis; and (b) is (i) a tetrahydrocannabinol; or (ii) an isomer, ester, or ether of a tetrahydrocannabinol; or (iii) an ester or ether of an isomer of a tetrahydrocannabinol; or (iv) a salt of any substance described in subparagraphs (i) to (iii); or (v) a substance that has a structure substantially similar to that of any substance described in subparagraphs (i) to (iv); and (c) for substances listed in paragraph (b)(ii) to (v), is capable of inducing more than a minor psychoactive effect, by any means, in a person. (a) contains cannabidiol; and (b) either (i) does not contain a specified substance; or (ii) contains specified substances in an amount that is no more than 2% of the sum of the amount of cannabidiol and the amount of specified substances in the product; and (c) does not contain any other controlled drug; and (d) does not contain any other psychoactive substance
Access to CBD products Access via a prescription from a medical practitioner under section 29 of Medicines Act Can be prescribed by GP List of products assessed against the QS will be made available CBD is a prescription medicine only
Restrictions and exemptions Products cannot be labelled with a clinical indication Products cannot be advertised Must be labelled Medicinal Cannabis Product Can be synthetic or naturally derived Exempt from meeting the QS when: a consented or provisionally consented medicine for a clinical trial prescribed for a named patient imported by a pharmacist pursuant to a prescription for a named patient.
How products are controlled Quality standards imposed on products via licences QS apply to: Starting material for export Cannabis-based ingredients Medicinal cannabis products Medicinal cannabis product can be a dried product or dosage product 6-month transition period for products already being prescribed to meet QS
