On October 31, the ODC released an online smart form and “flat” paper forms to apply for a cultivation, production or research medicinal cannabis licence. This online form can also be used if you seek a manufacturing licence but ONLY if you are also applying for a cultivation and/or production licence or a research licence. If you are applying solely for a manufacturing licence, visit the manufacturers’ section of the website.
A brief overview of the significant sections of the medicinal cannabis licence application is shown below; however, as per the TGA Guidance on GMP compliance for the manufacture of medicinal cannabis for supply under ‘approved access’ provisions, you may need to seek advice from a GMP consultant or seek legal advice if you are uncertain as to where GMP is required for your manufacturing process. The application may be for an individual or body corporate but essentially contain the same checks and information to be provided.
Applicant Details and Site Details
The first two sections look for the Applicant details and Site details. The applicant must provide information on how the land, premises and facilities can be accessed for inspection purposes. In addition, the applicant must attach a Site plan showing how the land will be used for the proposed licensed activities and a Floor plan of the premises and facilities where the proposed licensed activities will be undertaken.
Fit and Proper Persons
The next section on Fit and proper person requires information on the individual, or a body corporate, a list of names and dates of birth of all directors and officers of the body corporate. In addition, the section contains several questions about criminal history. Finally, it requires that any connections or associations the individual or body corporate, its directors or officers have with other people may affect the directors or officers’ reputation, character, honesty, or professional or personal integrity. Also required are National Police Check Certificates, resumes or details of professional qualifications and details on current financial circumstances, including but not limited to financial circumstances that may significantly alter the capacity of the body corporate to comply with a licensee’s obligations under the Narcotic Drugs Act 1967. The ODC has also created a Guideline for this section of the application.
Type of licence(s)
Details on the type of medicinal cannabis licence (multiple licences may be selected) requested by the application, whether it is for cultivation, production and/or manufacturing is asked. For example, if the application is for cultivation and production only, details of the arrangement with the holder of a manufacturing licence must be detailed.
If the licence includes manufacturing, details on the proposed drug (only one proposed drug allowed per application) and if supplied for research/clinical trial purposes or if proposed for supply must be included.
The Security Details section (along with an ODC Guideline) looks for the following information, along with evidence undertaking licenced activities or any areas within the site where cannabis or drugs will be stored. An overview of measures that will be in place to prevent unauthorised access to the site, including:
- Details to control all persons (including staff and contractors) entering the site
- Information on the equipment and any other arrangements that will be used to prevent, monitor, detect and record unauthorised access to the site
- Processes/procedures that will be in place for the starting materials, cannabis or drugs manufactured under licence such as:
- Ensuring the physical security
- Ensuring the loss or theft is detected and reported immediately
- Ensuring the safe and secure disposal or destruction
- Ensuring the safety and security of the supply, delivery and transportation (including the storage during transportation)
- Communicating with emergency services, police and local government authorities to deal with the loss, theft, spoilage, disposal or destruction of materials.
Risk management and record-keeping details
These sections apply to both cultivation and production licences, as well as research and manufacturing licences. Again, the ODC have a Guideline to provide support when completing this section.
The subsection indicates that there is no prescribed format for the plan, and each must be set to meet the needs of the business as intended in the application. Your risk management plan(s) should be a comprehensively documented plan that:
- identifies and documents foreseeable risks that could result in diversion
- estimate the impacts of those risks were to be realised
- defines mitigating steps to (prevent) reduce the risk
- specifies the persons, resources and actions needed
- describes responses to lessen the impact of the risk should the event occur despite mitigation.
A proprietary risk management plan must be attached.
This subsection also requires the proprietary document(s) containing detail on how aspects of the number of cannabis plants, cannabis or cannabis resin will be recorded during the period of the licence, including:
- The amount to be cultivated or obtained
- The amount to be maintained for propagation
- The amount to be produced and stored
- The amount to be supplied
- The amount that may be destroyed or disposed of.
Also, if for a Manufacturing licence:
- The quantities of drugs that the applicant manufactures under the licence
- The amount of starting material in possession of, or under the control of, the applicant at any time for the manufacture of drugs under the licence
The application for a medicinal cannabis licence also requests to detail the procedure the applicant will have in place to engage qualified staff and to provide details of each person employed by the applicant to carry out activities that are to be authorised by the licence, including attaching a copy of the National Police Check Certificate for each employee identified.