M edicinal cannabis in

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Victoria. Dr. Daniel Perkins. Manager Research Strategy and Policy. Office of Medicinal Cannabis. Department of Health and Human Services Victoria. Cannabis regulatory framework. Victorian reform. December . ID: 736866 Download Presentation

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M edicinal cannabis in

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Medicinal cannabis in Victoria


Daniel Perkins

Manager Research Strategy and Policy

Office of Medicinal Cannabis

Department of Health and Human Services Victoria


Cannabis regulatory framework


Victorian reformDecember 2014 VLRC asked to report on options for change allowing medicinal cannabis treatment, while continuing to prevent unauthorised accessThe Victorian

Access to Medicinal Cannabis Act

(AMCA) was passed in April

2016 and e

stablished stand-alone system including:

Regulation of cultivation and manufacturing

Processes for practitioner and patient authorisations

Eligible patient groups, initially children with intractable epilepsy, or people in exceptional circumstances

Approved product register


Commonwealth reform Late 2016, Commonwealth policy and legislative changes:Commonwealth regulation of cultivation

and manufacturing via the Narcotic Drugs


Changes to scheduling of medicinal cannabis products under the poisons


Patient access to medicinal cannabis via Commonwealth schemes for regulating access to ‘unapproved products’ (via the TGA SAS Scheme


Quality standards for medicinal cannabis - TGO 93 and GMPAvailability of imported medical cannabis products

22 June 2017


Current frameworkAnnounced in January 2018 that the AMCA would not be implementedCultivation -

Narcotic Drugs Act



Narcotic Drugs Act

and Victorian Drugs, Poisons and Controlled Substances Act 1981 Safety and quality - Therapeutic Goods Act 1989

Product access

If an unapproved product –

Therapeutic Goods Act (SAS/AP)

If a Schedule 8 product


Drug Poisons and Controlled Substances Act (S.8 treatment permit)


Patient AccessNovember 2016 – July 2018:Approximately 210 approvals granted for access for Victorian


Over 60% of approvals for Schedule 8 products

Most for ‘unapproved’


that require TGA approval


of prescriptions for the treatment of pain, nausea or vomiting in cancer patients or for chronic non-cancer painPatients are also accessing for treatment of symptoms of MS, epilepsy,


disease and mental health disorders

22 June 2017


Areas of complexityComplexity of access arrangementsCommonwealth-State responsibilities

Unapproved medicine

Limited/emerging evidence base


plant chemistry

Large array of product types

Cost (not subsidised via PBS)

Clinician and general public lack of knowledgeInteraction with other policy areas such as driving 16 August 2018


Further informationOffice of Medicinal Cannabis, Department of Health and Human Services Victoriahttps://www2.health.vic.gov.au/public-health/drugs-and-poisons/medicinal-cannabis

Therapeutic Goods Administration



Office of Drug Control




Contact details

To receive this publication in an accessible format phone 03 9096 7768, using the National Relay Service 13 36 77 if required, or email medicinal.cannabis@dhhs.vic.gov.au.

Authorised and published by the Victorian Government, 1 Treasury Place, Melbourne.

© State of Victoria, Department of Health and Human Services June, 2017.

Except where otherwise indicated, the images in this publication show models and illustrative settings only, and do not necessarily depict actual services, facilities or recipients of services. This publication may contain images of deceased Aboriginal and Torres Strait Islander peoples.

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