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

▶
regulatory issues relating to the growing and cultivation
SMART_READER_LITE
LIVE PREVIEW

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

Apr 12, 2023 406 likes •510 views

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

slide-1
SLIDE 1

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

slide-2
SLIDE 2

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
slide-3
SLIDE 3

02 The Medicinal Cannabis Framework

Import

slide-4
SLIDE 4

Cultivation and Production

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

slide-5
SLIDE 5

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
  • ffence’ 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

slide-6
SLIDE 6

Manufacture

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

slide-7
SLIDE 7

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
  • ffence’ 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

slide-8
SLIDE 8

Import

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

slide-9
SLIDE 9

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

slide-10
SLIDE 10

Questions