It is a condition of a medicinal cannabis licence that the licence holder must give information relating to activities authorised by the licence if requested by the Secretary.
All ODC licence holders who hold valid medicinal cannabis permits for cultivation and production or manufacture are required to provide periodic reports to the ODC about their activities.
This reporting process will assist with meeting Australian and international regulatory and reporting requirements.
The ODC also maintains close relationships with law enforcement agencies and other government agencies, undertakes sampling of cannabis crops cultivated under permits and will regularly perform desktop audits of licence holders.
Additionally, non-compliance may be detected through organised and planned monitoring activities undertaken by ODC such as inspections.
Reporting
You are required to report on:
- crops
- cannabis stock
- manufacturing.
Reports must be submitted quarterly using the ODC reporting template, showing monthly breakdowns.
Cannabis permit reporting template - XLSX 36KB
Reports must be submitted with the file name of 'ODC reporting Q[X year] [licence ID]_[Site ID]' (i.e. 'ODC Reporting Q1 2022 MC001_S01').
Each tab has a space at the top to include the ID number of the permit(s) under which the reported activities took place.
Separate reports must be submitted for each permitted site.
Reports should be submitted cumulatively, with running totals over the course of the calendar year.
Any tabs not relevant to permitted activities can be left blank. If any part of a tab is completed, columns that are not relevant should be filled with a zero (0) for data validation purposes.
Reports must be submitted at the end of each quarter to mcs@health.gov.au by no later than the 15th of the following month:
- Q1 report due by COB 15 April (reporting on January to March)
- Q2 report due by COB 15 July (reporting on January to June)
- Q3 report due by COB 15 October (reporting on January to September)
- Q4 report due by COB 15 January (reporting on January to December).
The Q4 report must also contain an annual reconciliation on the relevant tabs of all activities undertaken for the calendar year.
Guidance: Using the cannabis reporting template
Crops (Medicinal/Scientific)
Use the ‘Crops – Medicinal’ tab to report all plants generated for medicinal use, and/or the ‘Crops – Scientific’ tab to report all plants generated for scientific or research purposes.
The intention of the ‘Crops’ tabs is to track total plants generated, cultivated, transferred, harvested and failed/destroyed.
Cannabis stock (Cannabis stock >1% THC/ Cannabis stock ≤1% THC/ Cannabis Resin Stock)
The reporting on cannabis stock is split into three tabs (>1% THC, ≤1% THC and resin stock). They are designed to record how much cannabis an entity has on hand (as dried flower or resin) and to record the inputs and outputs over the course of each month.
Cannabis should be recorded as dry weight expressed as kilograms with 10% moisture content (or equivalent). There is a comments field to include any items of note, such as if there is a discrepancy in balancing the inputs vs outputs over a given period.
Manufacturing
The Manufacturing tab is designed to capture inputs and outputs of manufacture activities. Extract outputs should be broken down into delta-9 tetrahydrocannabinol (THC), tetrahydrocannabinol isomers (excluding delta-9 THC), and cannabidiol (CBD) obtained from extraction of cannabis, including the acids. Figures should record only the active extract(s) in kilograms, not include the solution it is suspended in.
All extract is to be recorded in the appropriate column as total gross weight and its relevant cannabinoid components.
Monitoring and inspections
The ODC is responsible for ensuring the effective compliance of licence and permit holders in meeting their obligations under the Narcotic Drugs Act 1967 (the Act). We use a range of legislative tools and engagement practices to ensure regulated persons are complying with their legislative obligations and take appropriate and proportionate actions where required. We engage with other areas of government at the State, Territory and Federal level to exchange information and ensure that regulatory compliance risks are effectively managed.
The ODC have authorised inspectors with regulatory powers under the Act and the Regulatory Powers (Standard Provisions) Act 2014 for monitoring, inspection and enforcement, including the ability to enter premises without consent and without notice.
Inspections are conducted on a risk-based approach and can include:
- activities to confirm licence holders are complying with requirements, or
- undertaken in response to referrals and complaints, information received through open sources (eg media reports), and tip-offs.
Licence holders may observe inspections, but it is an offence to impede, obstruct or hinder an authorised inspector while they undertake their activities on site.
Onsite inspections and visits
The ODC undertakes onsite compliance inspections for various purposes, particularly to:
- observe the operation and processes occurring on site, and that they comply with requirements,
- assist delegates make decisions on issuing Permits or Licence variations, and confirm completion of relevant site building works,
- undertake sampling and monitoring activities, or
- execute monitoring and investigative powers under the Narcotic Drugs Act 1967.
Onsite inspections are usually completed within 1 business day and followed by an outcome letter.
Virtual inspections
The ODC undertakes virtual inspections, where inspectors obtain documents, reports, photos and records, and consider these in comparison to requirements under the Act, Regulations, Licence conditions, and Permits.
Virtual inspections are generally followed up with an interview between inspectors and licence holders, to discuss the inspectors’ observations and outcomes. A letter will often follow this interview confirming outcomes and next steps in writing.
Responding to and managing non-compliance
The ODC takes a risk based approached to compliance and enforcement to identify non-compliance.
The ODC may apply a number of enforcement tools including enforceable undertakings, injunctions and infringement notices. The powers for using these tools are outlined in the Regulatory Powers (Standard Provisions) Act 2014.
The ODC may apply other compliance measures to ensure, or return a licence holder to, compliance, which may include providing education, issuing formal warnings, and undertaking follow up inspections.
Education
Where non-compliance is identified by the ODC, the authorised officer may engage in an educative conversation with the licence holder to discuss the ways in which the non-compliance can be addressed, rectified and prevented in the future. The outcomes of such conversations will be documented and will be given consideration in future instances of non-compliance.
Directions
The ODC can issue directions that a person take certain action, prevent particular activities from occurring or undertake other activities that ODC deems appropriate to meet their obligations as a licence holder. Failure to comply with a direction is an offence and may be used as grounds for revocation of a licence. Decisions to issue a Direction are reviewable decisions.
Variation/s to a medicinal cannabis licence or permit
The ODC can vary a medicinal licence or permit on its own initiative for various reasons, including in response to a major or critical non-compliance. Variations may be imposed to restrict the activities undertaken by a licence holder or to restrict the volumes of cannabis that can be cultivated and/or produced.
Suspension of a medicinal cannabis licence or permit
The ODC can suspend a licence for up to 6 months if satisfied that a reasonable ground exists to revoke the licence or permit. Before a licence is suspended, the licence holder is afforded an opportunity to provide submissions in response to a notice of intent to suspend a licence or permit. While a licence or permit is suspended, the licence holder may be permitted to engage in specified activities relating to cultivation, production or manufacture in accordance with conditions specified in the notice of suspension It is an offence when a person undertakes activities under a suspension if the ODC has not permitted such activity and the conditions of such permission are not complied with.
Revocation of a medicinal cannabis licence or permit
Revocation of a licence is a formal process that would be used in response to critical non-compliance. Revocation requires the ODC to be satisfied on reasonable grounds of the facts leading to the revocation. Before a licence or permit is revoked, the licence holder is afforded an opportunity to provide submissions in response to a notice of intent to revoke the licence or permit.
The ODC must revoke a licence if the licence holder, or any relevant business associate of the licence holder, is no longer considered to be a fit and proper person, and/or if the licence holder (including any officer or director within a body corporate) has engaged in conduct that constitutes a serious offence since the licence was granted.
A number of other circumstances exist in which the ODC has discretion and may revoke a licence or permit. These include, but are not limited to:
- the breach of a licence condition;
- the licence holder commits an offence against the Act;
- the site or security arrangements are no longer suitable;
- failure by the licence holder to provide information to ODC in a specified time; or
- the licence is no longer consistent with Australia's international obligations.
Civil penalties
There may be situations where the imposition of a civil penalty by a judicial authority is a more appropriate and effective response to non-compliance. When a civil penalty is imposed, the licence holder must pay a pecuniary penalty to the Commonwealth. The effect of a civil penalty on a licence holder can be significant and is likely to be used in response to more critical non-compliance.
Criminal prosecution
A criminal prosecution is the most significant sanction for breaching the law. The ODC has powers allowing it to investigate a matter for criminal prosecution under the ND Act, but may also refer the matter to the relevant law enforcement agency or regulator for investigation. Criminal prosecution could result in a conviction that is accompanied by a custodial sentence.