Example follow-up questions for medicinal cannabis licence applications

The application forms for cannabis related licences seek information and documents that are prescribed in the Narcotic Drugs Act 1967 (Cth) (the Act) and Narcotic Drugs Regulation 2016. The material requested in these application forms provides a foundation for the licence assessment processes.

To allow the delegate to make a decision on a licence application, there are a range of additional issues that must be covered in the assessment – to both support the decision making process and to cover off the general and particular circumstances where the delegate would otherwise be unable to grant a licence.

The Office of Drug Control (ODC) seeks additional clarification as requests for information through formal letters issued under section 14J of the Act.

Information requested from applicants under this model falls into two general categories:

• additional material not covered by the applicant in the application forms
• more detailed information sought where initial responses provided to the ODC are inadequate to support a determination to allow for a positive assessment outcome.

ODC has reviewed questions asked to applicants during the first three years of the operation of the medicinal cannabis scheme and pulled together some example questions that previous applicants have been asked to address.

It is hoped that these questions will assist applicants in preparing their applications; it should also assist applicants to prepare for the type of questions they are likely to be asked.

It is important to note that the list of questions is non-exhaustive and is provided to give examples only.

• Provide a summary of the proposed operations, for example the:
  • estimated scope and size of the operations
  • expected number of employees
  • a draft organisational chart, and/or
  • a business plan/summary of the activities.
• Describe the cultivation and production practices that will be used under the proposed licence.
• Confirm the owner or lessor of the site.
• Outline how access to the facility will be provided to authorised inspectors who attend on an unannounced visit under Section 14C of the Narcotics Drug Act 1967 (Cth) (the Act).
• Provide the operating processes and procedures relating to the cultivation and production of cannabis plants.
• Provide further clarification of your proposed arrangements with a licenced manufacturer.
• Confirm the projected mass of cannabis to be produced.
• For cannabis research licences or manufacture licences with a primarily research focus - provide a research proposal that contains further information about your anticipated research activities. This should include primary purpose of research, who will benefit from research, how many products may be developed as a result of the research, etc.
• How will you separate, either physically or procedurally, activities conducted under the authority of a cannabis research licence from activities conducted under the authority of a medicinal cannabis licence and/or a manufacture licence?

• Provide a floor plan that:
  • details security systems, including the expected locations and coverage of the security cameras, motion detector and alarm systems
  • outlines where the activities will be undertaken, illustrating the access points to all rooms and the facility, including the access controls
  • identifies each the building and the activities expected to be performed in the building
  • details the location where cannabis waste is stored and where destruction activities will occur, and/or
  • details restricted areas for staff members.
• Supply a site plan that is labelled with the different designated areas.

• How will you determine the access levels that personnel will be provided and what measures will be in place to verify that these access controls are used legitimately by personnel?
  • who manages the employee access and what operating procedures will be in place
  • for areas that have key locked and/or swipe access, detail measures in place to ensure all keys/ cards are returned or deactivated when employment ceases
  • detail what procedure/s is followed in the event of a stolen or lost key/card
  • who issues keys / swipe card to authorised persons, and/or
  • provide the Visitor Policy and the induction package for all visitors to the site, including the induction process for Authorised Inspectors from ODC.
• Provide a detailed outline of the security measures implemented to monitor the physical security systems, and the response to intrusion or unauthorised access, theft (suspected or actual) or loss.
  • Provide details about the measures proposed to maintain and test the efficacy of the security equipment.
  • Outline any contract in place with a third party provider, the roles and responsibilities specifically the functions of the security control room and the management of the security desk on site.
  • Who undertakes auditing of access or review of CCTV footage?
• The application states that an alarm system and motion sensors will be in place. Please detail the coverage and functions of these systems (e.g. what occurs when they are triggered, who will respond if they are set off etc.).
  • What are the security response protocols and triggers for an alarm?
• What measures will be in place to maintain discretion about the nature of the crop you intend to grow and the security of your site during the recruitment or tender processes?
• Provide a summary of any engagement that you have had to date with local law enforcement and emergency services.
• Describe the measures that are in place to prevent loss or theft of cannabis on site during usual business activities.
  • What action will be taken in the event where a contractor breaches the procedure for site access?
  • How will you detect of there has been unauthorised access to the site, by either an employee or an unknown person?
  • What policy and procedures are in place to prevent removal of medicinal cannabis from the site by employees?
• Provide the details of your contingency plans for security measures in the event of a power or communications outage.
  • Provide documentation detailing process followed in the event of an IT system issue.
  • What arrangements are in place in the event of a fire or other emergency requiring outside services?
• What methods do you intend to use to secure the site should a stock discrepancy be discovered?
• What security measures and procedures will be in place to receive deliveries into your facility?
• Provide details of arrangements in place, including standard operating procedures and policies in place to ensure the safety and security of the supply, delivery and transportation of cannabis any time it leaves the facility, including details of transport providers.

• What is the method of waste destruction and disposal that you will use?
  • Where and how will waste be stored until the point of destruction?
  • How frequently will waste be destroyed?
• Identify the likely sources of cannabis waste in your SOP and outline how record keeping effectively captures the movement and management of this material.
• Provide more detail about the waste management aspect of your proposed operations, for example if cannabis material will be destroyed on site, the measures in place to ensure that cannabis material cannot be diverted and to ensure it is properly destroyed.

• Your application listed a number of business partners, does any person or people from these entities have the ability to influence the operations of your company, either financially or operationally?
• Provide your company details from the Australian Securities and Investments Commission (ASIC) containing details of any shareholders and the proportion of the shares any such people have in your company.
• Does your company have any shareholders or are there any other individuals or entities that have invested funds into, have loaned money to or may otherwise have financial influence over the operations of your company? This may include relatives, partners, family members etc.
• For any persons identified as holding a position of influence over your proposed licence activities, provide contacts details and seek their undertaking to assist in the assessment process.

• Detail the proposed manufacturing activities; please note, the definition of manufacture under the Act is 'all processes, other than production, by which drugs may be obtained and includes refining as well as the transformation of drugs into other drugs'.
• Provide details of the approval or authority under the Therapeutic Goods Act 1989 (Cth) under which supply is to occur.
• Describe the starting materials you will require to manufacture the proposed drugs.
• Advise the steps you have taken to commence the clinical trial:
  • Has Ethics Committee Approval been granted?
  • Has a CTN or CTX number been obtained?
• Provide further of the drugs to be manufactured including:
  • year of intended manufacture
  • strength/concentration of tetrahydrocannbinol (THC)
  • description of the final drug (e.g. 10ml vial, capsule, etc.)
  • number of units required annually
  • total volume to be manufactured
  • quantity of starting material required