9 June 2020

The following information outlines the application process for licences and permits under the Narcotic Drugs Act 1967 (Cth) (ND Act).

This information is intended to provide clarity around the application process, when you may be contacted and estimated processing times.

The processing of licence and permit applications is a complex task. The legislation requires not only consideration of matters under Australian law, but also international obligations under the Single Convention on Narcotic Drugs of 1961, as amended (Single Convention).

Processing times are based on current resource allocations and business processes, and may therefore be subject to change.

Although the ODC endeavours to process applications as quickly as possible, some applications may take significantly longer than others due to the complexity of the application.

Note concerning manufacturing licences (GMP) issued by the TGA

A licence or permit issued under the ND Act does not replace or remove any licence or permission required under the Therapeutic Goods Act 1989 (TG Act). Refer to the information on Manufacturing licences and GMP or the Therapeutic Goods Administration website for information on licences that may be required for your products and activities under the TG Act.

Tips for completing our application forms

  • The applicant (the natural person or the body corporate) should read the application form along with the guidance material on this website.
  • Applications take less time to process where full answers, in plain English, have been provided in response to each question in the application form.
  • Every application is different, answers to questions and supporting material provided should be tailored to the specific circumstances of the applicant.

Licence and permit applications

A person may apply for a licence and permit under the ND Act. There are three types of licences which may be applied for:

  1. Licence to cultivate and/or produce cannabis* for medicinal purposes (Medicinal Cannabis Licence).
  2. Licence to cultivate and/or produce cannabis* for research purposes related to medicinal cannabis (Cannabis Research Licence).
  3. A Narcotic Manufacture Licence (including from cannabis*).

*Note that for the purpose of this document, 'cannabis' includes cannabis resin.

If your application is for more than one licence it will be assessed at the same time.

Permits relate to licence types and must be obtained before any activity to cultivate, produce or manufacture a drug may commence. Permits will describe and set limits on the quantities and types of drugs you are permitted to obtain. There are three types of permits:

  1. Medicinal Cannabis Permit
  2. Cannabis Research Permit
  3. Narcotic Manufacture Permit

Process summary

Licence applications

Licence applications are assessed in four stages:

  1. Application receipt
  2. Screening
  3. Evaluation
  4. Decision

Applications for licences are processed in the order they are received, with the exception of licence applications that have Major Project Status, which receive priority processing. Further information on Major Project Status can be found at business.gov.au. (Note that permits and licence variations are processed separately from new licence applications to minimise disruptions on persons who already hold a licence under the ND Act).

Note: the processing times indicated below are not statutory; they are targets that the Office of Drug Control endeavours to meet.

Stage Processing time targets

Application receipt

This process confirms that the application form has been completed and that the correct data package has been provided before an invoice is generated and the correct fee has been paid (where applicable).

Your application will not enter into the next stage of processing until all required information has been provided.

If your application has a fee attached, the application will not enter screening until the fee has been paid.

10 working days

Screening

This process reviews your application to ensure that the information and documents provided addresses legislative requirements and guidelines. Here, you may be required to provide further information.

If, following requests for information, your application is still incomplete (including failure to respond to requests) your application will be referred to the delegate to consider refusal.

You will be notified when your application has finished screening.

10 working days

Evaluation

Once your application has finished screening, it will be progressed to the evaluation stage and assigned to the next available assessor.

During the evaluation process you may also be required to provide further information about your application. If the requested information is not provided within the specified timeframe, your application may be referred to the delegate to consider a refusal to grant a licence.

During the evaluation process, a fit and proper assessment will be initiated.

Changes to your application during the evaluation process will incur additional working days to be added to the processing time.

When the assessor has completed the evaluation of your application, a report is provided to the delegate.

195 working days (includes decision)

Decision

The delegate will review the report prepared by the assessor and determine whether to grant, or refuse to grant, a licence.

The delegate may refer the report back to the assessor for more information. You will be formally notified when a decision is made.

Time included in the evaluation working days

Processing times are tracked by an application clock. If information has been requested from you, the application clock will be stopped. The clock will restart the next full working day after your response is received.

Requests for information and response due dates

If further information is required you will be contacted, usually by email. Your application will be clocked off when a request for further information has been made. The clock will restart from the next full working day after we receive your response.

All written requests for information will include a due date. Where such a request is made under 14J of the ND Act (a 14J request), a failure to provide the information request is a circumstance where the delegate must refuse to grant a licence.

You should contact this office as soon as possible if you are unable to meet response due dates.

See: Examples of questions you may be asked.

Decisions on applications

An earlier decision to grant a medicinal cannabis licence or a cannabis research licence does not imply that a similar decision will be made for a manufacture licence or vice versa.

The ODC has recently aligned the assessment and decision process for combined licence applications (where you have requested both a cultivation/production and manufacture licence or a cannabis research and manufacture licence) to remove duplication and requests for information.

Changes to applications by the applicant following submission

We recognise that some information provided in an application during the evaluation process may change due to varying circumstances, however changes may require additional evaluation time.

Licence screening

If a complex change is made by the applicant while the application is undergoing screening, the screening process may be restarted.

Licence evaluation

Simple changes

A simple change refers to an amendment that is administrative in nature. This may include:

  • Updates to contact details
  • Changes to the applicant's name (but not to the applicant itself)

Complex changes

Complex changes may include:

  • Change of site location
  • Addition of another site (or multiple sites)
  • Expansions to sites
  • Changes to building or security plans

Complex changes to applications may require additional evaluation time of up to 90 days each time a request is made.

Fit and Proper Person requirements

The ND Act requires a decision be made on the fit and proper status of the applicant. Considerations include the applicant, directors or licence holder themselves as well as their connections and business associates.

Applicants and licence holders must advise the ODC of any changes that may affect the fit and proper status of the applicant. Failure to do so could result in a number of remedial actions, including, but not limited to, directions, suspension of activities or licence revocation.

Changes to office holders, company directors etc. made during the assessment process may require an additional 90 days processing time.

Note: information relevant to the assessment of fit and proper person requirements is requested from other jurisdictions and agencies. The ODC has no control over the time it takes for external agencies to respond.

Expiry of licences

All licences and permits have an expiry date. If you intend to continue activities but your licence is due to expire you should contact this office at least three months before the expiry of the licence to discuss what options are available.

In some cases, you will be required to submit a new licence application (which may include a new fit and proper person assessment).

Outline of permit and variation application process

Permit applications

A permit is required before a licensee can commence cultivation, production or manufacturing activities. At a minimum, permits will specify the quantities of plant or drugs to be cultivated or manufactured and total quantity that may be held at any given time.

Permit applications will be assessed in three stages:

  1. Application receipt
  2. Evaluation
  3. Decision

Permit applications are processed as a priority and are generally quicker to assess than licence applications. As such, you may not be contacted regarding the progress of your permit application.

Requests for information and response due dates

If further information is required regarding your permit application, you will be contacted, usually by email. The time it takes to process your permit application will vary depending on the time it takes to respond to any request.

Please ensure you include the reference number in your response to reduce processing delays.

You should contact this office as soon as possible if you are unable to meet response due dates.

Decisions on permit applications

Decisions on permits will be affected by a number of factors. Consideration of the quantities to be cultivated or manufactured will be given when considering a permit, consistent with obligations under the Single Convention. For example:

  • Australia's overall cultivation/production levels
  • Australia's overall stock levels

Depending on the national stock levels, the quantities permitted may be less that you request.

Changes to permit applications by the applicant following submission

You may not change your permit application once submitted, unless agreed by an ODC assessor.

Expiry of permits

All permits have an expiry date. You may also have more than one permit per licence.

Licensees must ensure that they contact the office and apply for a new permit at least 60 working days before expiry of each permit to ensure licenced activities are not disrupted.

Variations

Applicant requested changes to current licences and permits

At times, licences and permits will need to have details varied to adjust for the activities of the licence holder.

Depending on the changes required, you may be able to request a variation to your current licence and permit, rather than having to apply for a new licence or permit.

Note: that for some variations a fee may be required.

Variations will either be of a simple* or complex nature.

*a simple variation refers to a change that is administrative in nature (e.g. change in contact details, change to the licence holder name (but not to the licence holder itself), extension of licence dates of operation)

However complex variations to applications may require additional evaluation time of 195 working days each time a request is made (multiple changes are permitted for each request).

If you wish to make a request for a variation, all requests must be in writing and on the correct form (if applicable) and include the licence or permit number to be varied.

Complex licence variations
  • Change of site location
  • Addition of another site (or multiple sites)
  • Expansions to sites
  • Changes to building or security plans

Outline of licence variation process

Note: the processing times indicated below are not statutory; they are targets that the Office of Drug Control endeavours to meet.

Process Timeframe

Application receipt

This process confirms that the correct fee has been paid, the licence variation application form has been completed and that the correct data package has been provided.

If any of the above is missing or incomplete, your application may be rejected and you will need to submit a new application.

10 working days

Evaluation

A variation can be made for a number of purposes. If there are to be complex licence variations to a licence you may be advised that a new licence is required.

When the assessor has completed evaluation, a report is provided to the delegate.

60 working days for simple licence variations

195 working days for complex licence variations

Decision

The delegate will review the report prepared by the assessor and determine whether to vary the licence.

The delegate may refer the report back to the assessor for more information.

You will be formally notified when a decision is made.

Time included in the evaluation working days.

Contacting this office

ODC will contact you when there is an update to an application status or when we need further information. If you do need to contact ODC, please do so via email. We can respond more quickly when you include your application, licence or permit reference number at the start of each email.

  • For all general queries, and queries about licence applications, and new sites:
  • For questions about invoicing:
  • For queries about permits and variations to existing licences:

Note: We are only able to discuss applications with the applicant or persons nominated as an approved contact in your application form or advised to the ODC in writing by the applicant or licence holder.