User guide: Completing a medicinal cannabis licence application for body corporate applicants

After submission, you will be sent an invoice for the application. This invoice must be paid within the timeframe specified. The application will not progress to assessment until payment in full has been received. Your application may be refused if the invoice is not paid.

You can seek assistance from the ODC by contacting (02) 6289 4618 (option 3) during business hours or by emailing MCS.application@health.gov.au.

The ODC contact officer cannot:

• provide advice on how to prepare your application,
• offer feedback or opinions about your application, including whether a licence is likely to be granted, or
• provide business advice.

All information provided in the application must be truthful and accurate. Legal sanctions can apply under Divisions 136 and 137 of the Criminal Code Act 1995 (Cth) to any applicant who knowingly provides incorrect information or withholds information that may be relevant to the decision. The ODC verifies information in an application with various Commonwealth, state and territory authorities, including law enforcement agencies.

Application steps

There are five steps to be completed before the application can be submitted:

1. Application details
2. Fit and proper persons
3. Site and security details
4. Additional information
5. Review and submit

To progress through each section, press the “Continue” button.

If you need to save your application to come back later, scroll to the bottom of the page you are on and press the “save and close” or “save for later” button. This will then exit you out of the section and save your progress. Note: This does not mean your application has been submitted.

Mandatory responses

Throughout the application form you will see (mandatory). This means the question must be answered to progress to the next part of the application. If you try to continue without completing these questions, you will get an error message that highlights the questions to be completed.

Multiple choice answers

Some questions give options to select from. Only one option can be selected for these questions. To select your choice simply click anywhere on the answer. The circle next to the selected option will be filled in.

Example:

In some cases, selecting a particular answer will reveal additional questions to be completed.

Text boxes

Some questions in the application allow for a text response to answer the question. For those questions, a maximum word count has been set which can be found at the end of the question.

Example:

Generalised or incomplete responses may slow the assessment and decision-making times. You can adjust the size of the text box so you can see more text by pressing the diagonal lines in the lower right corner and dragging down with the mouse.

How to upload documents

Some questions require the uploading of documents.

To upload a file:

1. Press the “+Add” button

2. A pop-up box will open. Press the “+ Add Files” button in the top left corner.

3. A pop-up box will open titled “Upload files”. Above this box will be information about the accepted file types, the maximum number of files and the maximum file size that can be uploaded. Press the button “Choose Files”.

4. The “file manager” window for your computer will appear. Select the file to upload.
5. The “Upload files” pop-up box will now re-appear. The name of the file selected should now appear in the box next to the “Choose files” button. If the wrong file was selected repeat Step 3 and 4 to select the correct file. Otherwise press the “Add files” button.

6. The pop-up box will reappear. To attach additional files, repeat from Step 2. Once all files to be submitted are listed. Press the “Done” button.
7. The submitted files will then be listed by filename on the form. To change the attached files at this stage, press “Edit”. Find the file to remove then press “Delete”. To attach another file follow from Step 2.

When asked to upload copies of legal documents, such as contracts, unsigned copies will not be accepted.

Your reference

You can create your own name for an application, for easy identification. This section is optional.

The system will also allocate a separate system reference number which will be used by the ODC in correspondence to identify the application.

Applicant details

Applicant details will be pre-filled from the information provided in the “Client Account”. If these details are incorrect, return to the “Client Accounts” section to update the details.

The proposed licence holder (the applicant) is the entity that will be legally responsible for the activities conducted under the licence, if granted.

The applicant can be a body corporate (a company with “Ltd” in its title), natural person (an individual), or an agency of the Commonwealth, or of a state or territory. A partnership or trust cannot be an applicant, but a trustee (as a body corporate or individual) may apply.

Irrespective of the person(s) completing the application form, the applicant is accountable for the accuracy of the information entered and submitted as part of the application.

Contact details

These are pre-filled with the information sourced from the contact information for the profile being used. If the details are incorrect you will need to change the details in the My Profile section of your user account.

Alternate Contacts (mandatory)

1. To list an alternative contact who the ODC can contact to discuss the application, select “Yes”.

A search bar will appear. Press the “search icon” and select the name of the person to be listed as the alternative contact.

If the person is not listed, the Client Account Administrator will need to invite that person to be a new user linked to the Client Account.

OR

2. Select “No” if no other contact is to be listed.

This section of the application seeks information relating to whether the applicant is “fit and proper” to hold a licence.

The ‘fit and proper person’ test is applied to the applicant and relevant business associates of the applicant. This helps the ODC to prevent criminal elements from infiltrating the licensing scheme.

Sections 8A and 8B of the Narcotic Drugs Act outline the matters the ODC may consider when making this decision and include a range of matters such as criminal history, connections, associations, financial status, and capacity to comply with licensing requirements.

Guidelines covering fit and proper persons and suitable staff are provided on the ODC website and should be read before completing this section.

Failure to meet some requirements relating to fit and proper persons does not necessarily mean that an application will be unsuccessful. The ODC will consider these circumstances on a case-by-case basis.

Company Details

A number of these sections require a current and historical company extract issued by the Australian Securities and Investment Commission (ASIC) to be attached.

Note that the extracts must:

• have been issued within the last 30 days before the application submission date.
• show the date of registration.
• list the office holders, and
• show the company share structure.

Where the company is a public company and shareholders are not listed on the extract, a separate list of shareholders (and the percentage of shares held) must be provided.

ASIC Current and historical company extract – For the applicant (mandatory)

Upload the ASIC extract for the applicant company.

ASIC Current & Historical Company Extract – For key company shareholders of the applicant

Upload an ASIC Current and Historical Company Extract for each company that has a 20% or more shareholding in the applicant company.

Deed/s of Trust – For key company shareholders of the applicant

For any person acting as a trustee, who holds a 20% or more shareholding in the applicant company, upload the relevant Deed of Trust.

If you have multiple Shareholders with >20% shareholdings who are trustees, please upload a word document stating, "Multiple Trust Deeds to be supplied". The ODC will then contact you to advise how to provide these documents.

Financial background

The applicant must provide evidence it has a sound and stable financial background and is not in financial circumstances that may significantly limit its capacity to comply with obligations under a licence.

The focus of requesting this information is to ensure that sufficient financial experience and reserves exist.

Applicants are expected to have the immediate capacity to meet planning, licensing and entity maintenance costs, such as licence fees, an annual licence charge and general business costs.

Applicants are not required to have all funds to meet infrastructure and development costs immediately available but must be able to demonstrate certainty of funding. For example, an applicant may not have the money in an account but may have a signed agreement with an investor.

The working capital needed to complete and operate the facility that an applicant is seeking a licence for will also be considered.

Recent bank statements or audited financial statements (mandatory)

Upload a recent bank statement, and/or audited financial statements, for the applicant that includes information or transactions for a period of at least 6 months.

If these documents cannot be provided in the name of the applicant, they should be provided for anyone who will be funding the applicant’s business.

Other evidence of sound and stable financial background

Include any additional evidence that shows the applicant’s ability to meet the financial obligations of a licence holder.

This should include as a minimum:

• evidence of total infrastructure and development costs and working capital required to complete and operate the proposed facility;
• any additional evidence demonstrating the applicant’s ability to cover planning costs, licensing charges, and other general business costs; and
• evidence proving funding will be available to meet these costs.

If you have provided recent bank statements and/or audited financial statements for someone other than the applicant, upload here a copy of the agreement outlining financial arrangements between the that person and the applicant. The agreement should state any amounts to be loaned to the applicant and any repayment terms.

The following are acceptable forms of evidence that may be provided:

• a list of the applicant’s assets;
• forecasted costs for site preparation and business implementation;
• any funding agreements in place with financial institutions, investors, or officeholders, e.g. a signed loan agreement from a bank or finance company, or a signed letter of commitment from an investor indicating how much funding they are prepared to provide and lending terms.

The following examples are not considered suitable evidence to demonstrate an applicant has a sound and stable financial background:

• a screen shot of an internet banking account.
• a letter from a bank advising only the balance of an account.
• a letter from an accountant attesting to the sound and stable financial background of the applicant, without supporting evidence.
• documents that do not identify the entity or person the document relates to (e.g. a bank statement with account holders name cropped out).
• documentation that is not in the applicant’s name that does not have a clear explanation as to its relevance to the application (e.g. a director’s bank statement where it has not been stated in the application that the director will be personally funding the operation).

Will there be any other financial support or funding provided to the applicant for the proposed licensed activities? (mandatory)

Answer either “yes” or “no”

If answering “yes” a text box will appear (mandatory). Details must be entered here of the other sources of funding for the applicant. Use this textbox to provide any other additional financial information you wish to be considered.

Convictions, civil penalties and/or revocations

The applicant is required to declare any conviction(s) for offences committed by the applicant, or the directors or officers of the applicant, against a law of the Commonwealth, a state or a territory at any time.

The ODC will liaise with other agencies to validate this information. Failure to identify director(s) or officer(s) that have been convicted of an offence may result in the application being refused or the revocation of the licence if such information comes to light later.

Has the applicant, or any director or officer of the applicant, been convicted of any offence/s? (mandatory)

Answer either “yes” or “no”

If answering “yes” 

• A text box (mandatory) will appear. Enter here details of the offence(s) including:
  • when the conviction was recorded
  • the nature of the conviction
  • the jurisdiction where the conviction was recorded
  • the consequence of that conviction, for example a custodial sentence.
• Answer “yes” or “no” to the question “Was the offence concerned committed at a time when any person who is presently a director or officer of the applicant, was a director or officer?” (mandatory)

• Answer “yes” or “no” to the question “Was the offence concerned committed at a time when any shareholder who is presently in a position to influence the management of the applicant, was a shareholder?” (mandatory)

Answer “yes” if the applicant committed the offence while any existing shareholder, who could influence the management of the company, held shares and had influence at the time the offence was committed.

Has the applicant, or any director or officer of the applicant, had any civil penalty (however described) imposed upon them? (mandatory)

Answer either “yes” or “no”

If answering “yes” 

• A text box will appear. Enter here details of the civil penalties(s) (mandatory) including:
  • the basis for the penalty.
  • the date the penalty was imposed.
  • the jurisdiction where the penalty was recorded.
  • the value of the penalty.
• Answer “yes” or “no” to the question “Was the conduct to which the civil penalty relates at a time when any person who is presently director or officer of the applicant, was a director or officer of the applicant?” (mandatory)

• Answer “yes” or “no” to the question “Was the conduct concerned performed at a time when any shareholder who is presently in a position to influence the management of the applicant, a shareholder?” (mandatory)

Answer “yes” if the applicant performed the conduct while any existing shareholder who can influence management of the applicant, had influence and shareholdings at the time the offence was committed.

Has the applicant had a licence or permit (however described) revoked or suspended under a law that relates to the prohibition or regulation of drugs? (mandatory)

Answer either “yes” or “no”

The applicant must disclose any revocation or suspension of a licence or permit (however described) held by the applicant that occurred under a law of the Commonwealth, a state, a territory or another country, where the law relates to the prohibition or regulation of drugs. The ODC will liaise with other agencies to validate this information.

If answering “yes” a text box will appear (mandatory). Enter details here including:

• the law that the licence or permit was issued under
• activities authorised by the licence or permit
• jurisdiction that revoked or suspended the licence or permit
• reason/s for the revocation or suspension
• period of the suspension

Good repute, business experience, connections, and associations

The focus of the questions in this section is to determine whether any directors or officers in the company may be subject to influences that could affect the applicant’s compliance with the Narcotic Drugs Act.

The ODC must consider the connections and associations of the applicant (and its directors and office holders). For this reason, there are several questions in this section designed to help the ODC understand more about the connections and associations.

Previous business experience (mandatory)

In this text box, provide details of the previous business experience of each of the applicant’s directors and officers, and any shareholders (if known) who can influence the management of the applicant. The response should demonstrate skills and experience relevant to running a business in a regulated industry.

Reputation, character, and integrity (mandatory)

In this text box provide details for each of the applicant’s directors and officers demonstrating their good reputation. The response should demonstrate each person’s character, honesty, professional and personal integrity.

Does the applicant, its directors, or officers, have any connections or associations with other persons that may affect whether the applicant is considered a fit and proper person to hold a licence? (mandatory)

In this text box identify any people the applicant (or its directors or officers) has a connection or association with that could affect whether the applicant is considered fit and proper to hold a licence. Such associations include relatives of the directors or officers.

Some examples of associations that should be included are persons:

• with links to criminal or outlawed organisations
• with a criminal history or who have served a custodial sentence
• who have had a civil penalty imposed

Will any family members of the directors or officers of the applicant be involved in authorised activities, financing, or benefit from the licence? (mandatory)

This question is used to determine whether any decision makers or persons handling the affairs of the company may be subject to influence that could affect compliance with the conditions of the licence.

Answer “yes” or “no”

If answering “yes” a text box will appear (mandatory). Enter details here of any family members of the directors or officers that will be involved in the authorised activities, or provide finance for, or benefit from, the licence.

Example: The wife of a director of the company will be employed as chief researcher. This should be disclosed in the application, even if the employment is not intended to commence until after the licence is granted.

Other information

Include in this text box any other information, not already provided, to be considered relating to whether the applicant is fit and proper to hold a licence.

Licence history

Include in this text box details of any licence(s) the applicant has previously held under the Narcotic Drugs Act and associated compliance history. Include:

• Name of licence holder and licence number
• Dates of operation
• Brief details of any warnings, infringements, suspension, revocation, civil or criminal penalties (if any).

Business associates

Business associates could use their relationship with a licence holder to obtain information, gain access to cannabis materials and influence them to undertake illegal activities on their behalf.

To protect the integrity of the licensing scheme, the ODC asks for information about the applicant’s business associates.

Two or more people are considered business associates, in relation to a business, if:

• Each person holds a position as a secretary, director, partner, trustee, manager, or other executive position (however described)

OR

• Both holds a financial interest (share in capital of the business or have an entitlement to receive income from the business) OR has the power to participate in directorial/managerial/executive decisions or can elect someone to a position as described in point 1 (either directly or on behalf of another person) in the business.

AND

• As a result of that interest or power, has significant influence over the business and/or its operations.

Is there anyone who is considered a business associate of the applicant? (mandatory)

Answer “yes” or “no”

If answering “yes” a text box will appear (mandatory). Provide details for each business associate. Such details should include:

• the full name of the business associate
• the nature of the association

Informed consent

This form provides consent to the ODC collecting an individual's personal information and disclosing it to relevant third parties, for the purpose of assessing the application and verifying information about that person.

Under this section invites will be sent to individuals to complete an informed consent form. At least one director of the applicant company must complete an informed consent form before you can proceed further with the application.

The following table lists other persons who should be invited to complete the form:

To invite someone, press the “+ New invite” button.

A pop-up titled “Invitation for informed consent” will appear. From the drop-down list select all that apply. Type in details of the person who will receive the invite.

A message will appear saying if the invitation email has been sent. To invite another person, press “Close” then repeat the invitation process.

A list of all persons invited to complete the form will appear each with the status on whether the form has been completed or not. If the status is “Sent” you can edit the invite, choose to re-send the invite or delete that person from the invitation list. To do this, press the “…” button.

Select the relevant option from the list “Edit”, “Re-send” or “Remove”.

The invited persons will receive an email asking them to complete the informed consent form. This email contains instructions on the steps to be followed or you can follow the instructions on the ODC website.

Persons living overseas

The ODC need to understand if any persons in decision making positions reside outside of Australia to ensure we provide correct information to the other agencies we share information with. The applicant will need to ensure they have in place appropriate methods for checking these persons meet the requirements for suitable staff (See section 10F of the Narcotic Drugs Act and section 18 of the Narcotic Drugs Regulation 2016).

Do any of the people listed to provide informed consent currently live overseas?

Answer “yes” or “no”

If answering “yes” note that the ODC may contact you to seek additional information on those individuals.

This section of the application seeks details about the location(s) where authorised activities will take place and the security measures that will be implemented.

Applicants must have control of the premises at the proposed location, with the ability to construct, fit out, and maintain buildings and security as required. This control may be achieved through ownership of the proposed premises, a lease, or some other kind of arrangement.

A guideline covering security of medicinal cannabis is provided on the ODC website and should be read before completing this section.

Applicants must be able to demonstrate a legal right to access the locations nominated for authorised activities.

Site details summary

Site(s) for licence activities

Where the applicant is applying to conduct authorised activities at more than one premises, the applicant must provide information for each premises.

To add a site press “+ Add site”. A new page will appear titled “Site Details”.

Site details

Physical or street address where the proposed activities will take place.

If the address is known

Use the search bar (under “Search for an address”) or type the address details in. If using this option, “Address line 1”, “Suburb/Town/City”, “State”, “Postcode” and “Country” are all mandatory fields.

If there is no physical address yet for the location

For example, where the proposed site is known but an address has not yet been gazetted. Tick the box “The physical address is not available”. If using this option, the latitude and longitude geographic co-ordinates are mandatory fields.

The total area of the land at the address (m2) (mandatory)

Provide here the total area of the parcel of land in metres squared. This should be the area of the land as recorded on the registered title (or proposed title) to that land.

Total secured area for the proposed licensed premises (m2) (mandatory)

Provide here the total area that will be secured (i.e. controlled) in metres squared.

Government zoning (mandatory)

Provide here the state or territory government zoning of the land for land use.

The applicant must advise the government zoning for the land at the proposed site. This is to ensure that the proposed site is in a zoned area that allows the intended activities to be conducted.

Does the applicant own the proposed licensed premises? (mandatory)

Answer “yes” or “no”

If “yes”

Use the “+ Add” button to upload files that document the applicant’s ownership of the premises.

Formal evidence of ownership must be provided (mandatory). This can be in the form of a deed of ownership, certificate of title, rates notice, etc. The documents must name the applicant as the owner.

If “no”

Is the proposed licensed premises leased by the applicant? (mandatory)

Answer either “yes” or “no”

If answering “yes”

The lessor must be aware of the proposed activities at the site.

• Provide the details of the landlord. At a minimum the landlord’s family name and address must be provided.
• Answer “yes” or “no” to the question “Is the landlord aware of the proposed activities that will take place on the land?” (mandatory)
• Upload a copy of the lease agreement (mandatory). This document must list the applicant as lessee and the person named as the lessor. It must also detail the terms of the lease, including length and compensation.

If answering “no”

• A text box will appear. Here provide details of the arrangement in place that gives the applicant the legal right to use or occupy the address where authorised activities are proposed. Include details of whether the applicant has the right to construct, maintain, and exclusively use facilities at the location.
• Upload at least one form of documentary evidence of the arrangement, such as a signed agreement between the owner of the land and the application.

Authorised persons for this site

Certain persons in positions of authority will be listed on the licence, if granted. These people are known as “authorised persons”. In this section, you are asked to provide the full name of anyone who holds one of the following positions:

• A manager or supervisor in direct control of activities authorised by the licence.
• Any person responsible for controlling on a daily basis activities authorised by the licence

This does not include staff who perform the activities, for example a cultivation assistant, if they will be acting under the instruction of an authorised person.

Authorised persons are responsible for ensuring a licence holder complies with its obligations under the Narcotic Drugs Act and could be personally be subject to enforcement action if serious non-compliance is detected.

The details of at least one individual must be given. The person must already be listed as someone associated with the applicant in the Client Account. See Manage a Client account for details on how to add a new user to the account.

To add a person press “+ Add person”. A text box titled “Authorised person” will appear. Select the person to be listed from the drop-down menu.

For each individual added, two questions will be asked:

• Will this person hold a managerial or supervisory position that will have direct control over the activities authorised by the licence at this particular site? (mandatory).
• Will this person be responsible for controlling on a daily basis the activities authorised by the licence at this particular site? (mandatory).

Answer either “yes” or “no” to each as applicable.

After adding a person their name will appear in a list on the application. If you need to delete the person or edit the details, press the “…” button and select from the list of options.

Press “Exit” to return to the “Site details summary” page without saving. Press “Continue” to proceed.

Authorised activities

There are three main activities that may be authorised under a medicinal cannabis licence:

• cultivation
• production, and
• manufacture.

An applicant may apply to undertake one, or more, of these activities. Often cultivation and production activities are applied for, and granted, together.

It is possible to apply at a later stage, should the licence be granted, for the licence to authorise additional activities, by making a licence variation application.

Details of the authorised activities to be conducted at each premises must be provided.

At this site, the applicant intends to conduct:

Cultivation Answer “yes” or “no” (mandatory)

Production Answer “yes” or “no” (mandatory)

Manufacture Answer “yes” or “no” (mandatory)

If answering “yes” to either conducting “cultivation” and/or “production” activities please advise (all mandatory):

• The THC and/or THCA content of cannabis materials to be used in the proposed licensed activities. Answer either:
  • “Will not exceed 1% w/w THC or equivalent THCA” (i.e. only low THC), OR
  • “May on occasion, or will always, contain 1% w/w or greater THC or equivalent THCA” (i.e. high THC and low THC OR only high THC)
  • Where will the cannabis plants be cultivated? Answer either:
    • Indoor only, OR
    • Outdoor only, OR
    • Both indoors and outdoors
  • Cannabis cultivation area. Provide the area, in metres squared, for indoor, outdoor and total cultivation areas (as applicable). If not cultivating both indoors and outdoors,
  • Proposed cultivation and production activities. Describe the cultivation and production activities that the applicant intends to undertake in the text box provided.

• Proposed supply of cultivated cannabis plants, cannabis or cannabis resin. Detail who any cannabis plants (including cuttings, tissue culture etc), cannabis (i.e. fruiting or flowering cannabis tops) or cannabis resin (produced via mechanical methods) will be supplied to and for what purpose. Include detail of the checks that will be undertaken to ensure these products are only supplied to someone who can lawfully receive them.

If answering “yes” to conducting manufacture activities, please advise (all mandatory):

• Details of proposed manufacturing activities. Provide here a description of the manufacturing activities the applicant proposes to undertake. Include detail such at the method of extraction and whether any refinement or transformation from one drug into another (along with details of the method to be used) will be undertaken.
• Supply of the cannabis drug. Use this section to detail who any cannabis drug will be supplied to. Include detail such as if the product will be:
  • used in medicinal or scientific research, clinical trials, in a finished medicinal product for human use (registered or unregistered per the Therapeutic Goods Act 1989) or used as a reference standard.
  • supplied to a pharmacist in a public hospital or to a pharmacist to extemporaneously compound, or as a finished product, for supply in accordance with an approval or authority under the Therapeutic Goods Act 1989.
  • Supplied to another manufacturer licensed for manufacture under the Narcotic Drugs Act or under part 3-3 of the Therapeutic Goods Act (i.e. a Australian based GMP licensed manufacturer).
  • Exported.
  • Include detail of the checks that will be undertaken to ensure the cannabis drug(s) will only be supplied to someone who can lawfully receive them.

Site suitability

Suitability of site location (mandatory)

Describe why you believe the proposed licensed premises is a suitable location to conduct authorised activities under the licence.

Some examples of issues the applicant should address in this section include:

• Suitability of the zoning for the land for the activities proposed.
• Details of any sensitive or vulnerable populations that may be in the vicinity, such as schools, businesses and other facilities.
• Is the site in a residential, rural or industrial area?
• Is there neighbouring properties? If so, how will the applicant ensure that the authorised activities being conducted under the licence will be shielded from neighbouring properties?
• Will there be dwellings located on the site?
• Is the location of the proposed site on a main road?

Are there any other businesses co-located at the proposed site? (mandatory)

Answer “yes” or “no”

If answering “yes” detail the measures (if any) that will be undertaken to separate the activities of each business (mandatory).

Include detail of the nature of the other business(es), any access control measures that will restrict access, security and other measures that will be used. You should also include detail on whether systems such as CCTV, security etc will be maintained separately from other business(es) onsite.

Apart from other businesses, are there any other activities that occur at the proposed site that are not related to the licence? (mandatory)

Answer “yes” or “no”

If answering “yes” provide details of the other activities that occur at the proposed site that are not related to the licence (mandatory).

Include detail such as the nature of the activities and what measures will be undertaken to mitigate any risks to the licensed activities.

Satellite image of proposed site (mandatory)

Upload a satellite image including a security overlay and the location of facilities/premises. The image should show existing infrastructure, dwellings, businesses and where activities unrelated to the licensed activities will take place. The image should also show neighbouring properties, dwellings and businesses.

Facilities at the proposed site (mandatory)

In the textbox provide details of which, if any existing infrastructure will be retained and provide details of any new infrastructure to be built. Include detail such as materials that will be used in building construction and how rooms will be used (e.g. Room 121 will be used for drying and bucking activities, Room 122 will be a staff lunchroom etc).

Are there any existing buildings on the proposed site? (mandatory)

Answer “yes”, “no” or “partial”

If answering “yes” or “partial” the following question will appear:

Will authorised activities take place in existing buildings? (mandatory)

Answer “yes” or “no”

Will buildings and facilities need to be constructed or fitted out should a licence be granted? (mandatory)

Answer “yes” or “no”

If answering “yes” upload one document that outlines the projected construction and/or fit out costs (mandatory)

Construction and fit out costs should be broken down, and detail estimated completion times

Does the applicant hold a State/Territory licence or authorisation to cultivate industrial hemp or manufacture narcotic drugs? (mandatory)

Answer “yes” or “no”

Answer “yes” even in the industrial hemp and/or licence to manufacture narcotic drugs is for another site.

If answering “yes” upload copies of all state/territory industrial hemp AND narcotic drug manufacture licences/authorisations (mandatory)

Do not upload copies of any licences/authorisations issued by the ODC or TGA in this section.

Site and floorplan

Site plan/s (mandatory)

A site plan must be uploaded here including the following information:

• Clear labelling.
• A legend.
• A scale.
• The boundaries of the proposed site including any fencing or physical barriers.
• All entrances, exits and points of access to the site, including gates.
• All buildings/structures that are or will be on the site, including fences, water tanks, sheds, awnings, trees, large shrubs etc.
• Areas where different authorised activities will take place. Including the location and dimensions of outdoor growing areas, if applicable.
• Security overlay, including placement of any external access controls and security equipment, such as CCTV camera or motion sensors.
• The location of other businesses or dwellings on the site.
• Areas where any unregulated activities will occur.

Floor plan/s (mandatory)

A floor plan of all buildings where authorised activities will take place should be uploaded here. The floor plan should include:

• Clear labelling.
• A legend.
• A security overlay, showing the location of all security measures such as CCTV cameras, security sensors (such as reed switched and motion sensors), and access controls.
• Entry and exit points to all rooms/areas, including internal/external doors and windows.
• Unique names for each room or area within each building or structure. Including the location of cultivation areas, drying areas, manufacture areas, areas where data is stored, vault(s), safe(s) and storage areas.
• Toilets and break rooms.
• Total area in m2 for each of the rooms and areas where authorised activities are proposed.

Security details

This section requires the applicant to answer questions about security, including detailing the measures that will be in place to ensure the physical security of cannabis plants, cannabis, cannabis resin or cannabis drugs that will be:

• in the applicant’s possession or control, or
• obtained, cultivated or produced, or manufactured under the licence.

As a minimum, security measures need to meet the expectations outlined in the Guideline: Security of Medicinal Cannabis.

External perimeter

The external perimeter comprises of the zone between the boundaries of the site (i.e. the perimeter of the parcel of land) and the first security barrier surrounding the facility.

Perimeter fencing or barrier (mandatory)

In this textbox provide detail the barriers within the external perimeter zone (including fencing, bollards or other physical barriers). Include detail such as:

• The material the barrier is constructed from.
• The height of the barrier.

For elements such as bollards, how far they will be spaced.

• Any screening used.

Do not include any security measures (such as vibration sensors) here.

Gates (mandatory)

In this textbox provide detail of any gates (and other entry mechanisms such as turnstiles, sallyports, boom gates etc) that allow access to the facilities through the external perimeter. Include detail such as:

• The material the entry point is constructed from.
• The height of the entry point.

Other equipment (mandatory)

In this textbox provide detail of any other external equipment that prevents, monitors or controls access to the site. This includes:

• Access control mechanisms - such as swipe cards, fobs, keyed locks etc used to restrict immediate access to the secure area.
• Security sensors - such as reed switches, motion/infra-red/vibration sensors etc.
• Monitoring – such as CCTV, guard patrols etc.
• Include here references to relevant policies/standard operating procedures. For example, “See Page 12, SOP1.112 – Security response for details on the response when an alarm is triggered”.

Secondary barriers

Secondary barriers are situated in the zone between the external perimeter and the facility entrance.

Construction of the facility or secondary barrier (mandatory)

In this textbox include details of the external construction of the facility (walls, roofing etc) and any other barriers in this zone (e.g. removable bollards in front of doors etc).

For example:

• The facility is made from 50MPa reinforced concrete blocks.
• 12 x 50cm high removable bollards are on the northside in front of the Colourbond steel roller door and spaced at 30 cm intervals.

External doors (mandatory)

In this textbox detail the number of external doors (including roller doors, fire exits etc) and the method used to secure them. Include detail of the location of the doors.

For example:

• 1 x front entrance door, northside, secured via magnetic locks
• 1 x roller door, northside, secured via magnetic and keyed locks
• 2 x fire doors, eastside, secured via self-latching lock with emergency bar release
• 2 x doors, westside, secured via restricted keyed locks
• 0 x doors, southside

Windows (mandatory)

In this text box detail the number of windows and how they are secured. Detail such as the window opening type (e.g. fixed, sliding, side hung inward etc) and the location on the building exterior should be included.

For example:

• 1 x fixed window, northside
• 2 x sliding windows, eastside, secured via fixed steel bars spaced at 5cm intervals
• 3 x sliding windows, westside, secured via keyed locks and fixed security screens

Tertiary barriers

The tertiary barriers are located inside the facility. In this section details must be provided of the measures that will be in place within the facility to ensure the security of cannabis materials.

Tertiary barriers, measures or equipment (mandatory)

In this text box detail the barriers, security measures and equipment that will be used inside the premises. This includes:

• The type, number, and location of security measures.
• Include items such as access control sensors, security sensors (e.g. reed switches, PIR sensors, etc).
• How access controls will be configured and monitored, including by who.
• Procedures that will be in place for visitors and contractors to move throughout the facility.
• Procedures in place in the event of a power outage.
• Any procedures and/or security measures that will be in place to detect, deter and prevent security breaches.

Storage

Storage security (mandatory)

In this text box provide details of security measures that will be in place for cannabis materials being stored. Include details of vault(s) and/or safe(s) as well as the containers used to store cannabis materials (such as locked bins etc).

What is the capacity of the vault or safes(m³)? (mandatory)

Enter as a figure (up to 10 digits) the total volume (in metres cubed) of all vault(s) and safe(s).

What is the maximum capacity of areas that will be used for cannabis waste (m³)? (mandatory)

Enter as a figure (up to 10 digits) the total volume (in metres cubed) of areas used to store cannabis waste.

Safety and security of supply, transportation and disposal

Safety and security measures for supply, delivery, and transportation (mandatory)

In this text box provide details of the procedures that will be in place to ensure the physical security of cannabis plants or cannabis drugs during supply, delivery, and transportation. Details of the following should be included:

• The procedure that will be followed to check the person ordering the cannabis material has the appropriate licences/approval.
• How and who will transport the cannabis material.
• How consignments will be packaged.
• What security/monitoring will be in place during transportation of consignments.
• How receipt of consignments will be confirmed.

Secure disposal or destruction arrangements (mandatory)

In this text box detail the arrangements to ensure secure destruction/disposal of cannabis plants or cannabis drugs.

Details that should be provided include:

• The method used for destruction.
• Where destruction will take place.
• Who is responsible for destruction/disposal.
• How destruction/disposal is verified and recorded.

Loss/theft mitigation

Loss includes cannabis material that cannot be located or that must be destroyed due to an unexpected event (e.g. contamination of cannabis material, deaths of plants due to disease or infestation).

Theft is where cannabis material has been taken without authority, or for an unlawful purpose.

Detection of loss and theft (mandatory)

In this text box, include details of how loss and theft will be detected. Include information such as:

• Procedures for monitoring access and security.
• Processes in place to detect theft by staff.
• Measures that will be taken to detect falsification and/or modification of records.
• How any loss or theft during transportation/supply will be detected.
• Processes for reconciling and auditing records related to cannabis materials.

Supporting documentation

Policy or standard operating procedure (mandatory)

Upload one policy or standard operating procedure that outlines the:

• Measures in place to prevent unauthorised access (both physical and electronic).
• Equipment used to prevent, monitor, detect and record unauthorised access.
• Measures used for physical security at the location.

Emergency services

Arrangements with emergency services (mandatory)

In this text box, provide details of the measures that will be taken to establish arrangements with emergency services (e.g. police and fire services) dealing with the loss, theft, spoilage, disposal and destruction of cannabis plants and/or cannabis drugs.

Employment arrangements

Employ or engage suitable staff (mandatory)

In this text box, detail the processes that will be used to check only suitable persons per the requirements of the Narcotic Drugs Act 1967 (See section 10F of the Narcotic Drugs Act and section 18 of the Narcotic Drugs Regulation 2016) are employed/engaged. Include detail on the processes that apply to any staff residing overseas, if applicable.

Ensure staff remain suitable (mandatory)

In this text box, detail the processes that will be used to check staff remain suitable persons per the requirements of the Narcotic Drugs Act. Include detail on how frequently these processes will be undertaken.

Additional supporting information

Other supporting information

Use this text box to provide any other information in support of the application.

You may leave this field blank.

The ODC may seek further information from applicants during the assessment process should it be required for a decision to be made on whether to grant or to refuse to grant a medicinal cannabis licence.

Commercial/non-commercial purposes

A non-commercial medicinal cannabis licence is where the licensed activities are undertaken primarily or wholly for medical or scientific research that is not intended for profit (e.g. a researcher conducting studies on the best cultivation methods to increase cannabinoid content as part of a PhD thesis).

To support non-commercial medicinal and scientific research in Australia, the Regulation allows for a licence to be a non-commercial medicinal cannabis licence and subject to reduced annual charges. Non-commercial licences are granted for a specified period (i.e. they have an end-date). The end date is related to the period of the proposed research.

Will the proposed licence activities be undertaken for, or primarily for, medical or scientific research that is for a non-commercial purpose? (mandatory)

Answer “yes” or “no”

If answering “yes”

The following questions will appear:

• Is the applicant seeking notification by the Secretary, under paragraph 54A(1)(c) of the Narcotic Drugs Regulation 2016, that the licence (if granted) is classed as a non-commercial medicinal cannabis licence for charging purposes? (mandatory)
  Answer “yes” or “no”
• Purpose of the research (mandatory)
  In this text box briefly detail the primary purpose of the research and the activities that would require a medicinal cannabis licence.
• Beneficiaries of the research (mandatory)
  Detail who will benefit from the research being conducted. In the activities conducted under the licence will be used for other purposes after the research process, detail who will benefit from these other purposes.
• Product use (mandatory)
  In this text box, outline the end use of the results of the research conducted. For example: “This product will be used in stage 3 clinical trials carried out by Dr X at the University of Australia”.
• Research and activity funding (mandatory)
  Here provide details of any additional funding, specifically for the research activities, including who will be providing the funding. If the funding is from the same sources as those detailed in the “fit and proper person” section note “See Financials in Fit and Proper Person”.
• Facilities owner (mandatory)
  Provide details here of who owns and operates the facility where the activities will be taking place. For example: “The facilities are owned by the University of Australia and will be leased by the applicant for a period of 12 months”.
• Time period (mandatory)
  In this text box detail, the time period over which the research will be conducted. Include the date research is anticipated to commence.
• Check the box to acknowledge the licence, if granted and classed as “non-commercial” may be granted for a specified period.

Use the down arrow to expand each section to review.

If changes are required, press the “edit” button. This will return to the relevant section where changes can be made.

Once satisfied the application is ready to submit:

• Check both declaration checkboxes (mandatory) and read the statement in relation to the submission of the application.
• Press the “submit” button.

Invoice

After submission, you will be sent an invoice for the application. This invoice must be paid within the timeframe specified. Once paid, this fee is not refundable even if you chose to withdraw the application. However, you may withdraw the application prior to paying the invoice.

Correcting an application after submission

Once the licence application form has been submitted, it cannot be altered and you will need to discuss any changes with the ODC. If you become aware that a change is required then you should notify the ODC immediately by emailing MCS.application@health.gov.au.