An introduction to the Office of Drug Control’s Medicinal Cannabis Framework including requirements for Cultivation & Production, Manufacture, and Importation.

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

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

3. 02 The Medicinal Cannabis Framework
Import

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

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
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

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

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
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

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

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

10. Questions