Regulatory issues relating to the growing and cultivation of - PowerPoint PPT Presentation

Regulatory issues relating to the growing and cultivation of cannabis for medicinal purposes RACI Pharmaceutical Science Group (NSW) Bill Turner, Head of the Office of Drug Control 28 March 2017

What is the Office of Drug Control? • Part of the Health Products Regulation Group, Department of Health • Administers: • Regulations 5, 5H and 5G of the Customs (Prohibited Imports) Regulations 1956 • Regulations 10 and 10A of the Customs (Prohibited Exports Regulations 1958 • The Narcotic Drugs Act 1967

02 The Medicinal Cannabis Framework Import

Production is the removal of the cannabis from the cannabis plant Medicinal cannabis Cultivation and licence – can authorise cultivation or Production production or both Cannabis research licence – authorises research into the medicinal properties of cannabis

Cannabis licence requirements • Fit and Proper Persons test set out in legislation • Must be of good character • Must be financial • Must have the capacity and capability to undertake a cannabis cultivation business • Must not have engaged in ‘conduct constituting a serious offence’ in the past 10 years • Must make appropriate security arrangements • For a medicinal cannabis licence, must have a business relationship with a licensed manufacturer • For a cannabis research licence, must be undertaking appropriate research

Manufacturing Licence – GMP Therapeutic Goods Administration Manufacturing Licence – Manufacture State and Territories Manufacturing Licence – Office of Drug Control – Narcotic Drugs Act 1967

Manufacture licence requirements • Fit and Proper Persons test set out in legislation • Must be of good character • Must be financial • Must have the capacity and capability to undertake a cannabis manufacture business • Must not have engaged in ‘conduct constituting a serious offence’ in the past 10 years • Must make appropriate security arrangements • Must be able to demonstrate that supply will be in accordance with the Therapeutic Goods Act 1989

Import Licence – Regulation 5 of the Customs (PI) Regulations Import Import permission for each consignment – Regulation 5 of the Customs (PI) Regulations

Import requirements • Fit and Proper Persons test • Licensing process is to determine if the applicant is a suitable person to be importing and handling narcotic substances • Permitting process is the ‘international currency’ system – an import permission indicates a country’s willingness to import; this allows the exporting country to issue ‘export permission’. • In the international trading system, the import permission and the export permission ‘marry up’ to track quantities traded and prevent over-production • Subject to record keeping requirements to ensure appropriate use

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