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Application process for licences and permits under the Narcotic Drugs Act 1967

Outline of the application process for licences and permits under the Narcotic Drugs Act 1967.

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Introduction

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 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

An applicant (a natural person or body corporate) may apply for a medicinal cannabis licence and permit under the ND Act. This will allow for a licence holder to carry out one or more activities in accordance with their permit.

A single licence can authorise a person to apply for a permit to:

  • cultivate cannabis plants, for the purpose of producing cannabis or cannabis resin, for medicinal or scientific purposes
  • production of cannabis or cannabis resin for medicinal or scientific purposes
  • manufacture a cannabis drug for one or more permitted supplies.

A medicinal cannabis licence must be granted to an applicant before an application for a permit can be made.

A permit must be obtained before any activity to cultivate, produce or manufacture a drug may commence. Permits describe and set limits on the quantities and types of drugs you are permitted to obtain or produce, and are time-limited. There are two types of permits:

  1. Cultivation and/or Production Permit
  2. Manufacture Permit

Process summary

Licence applications

Licence applications are assessed in three stages:

  1. Application receipt
  2. Assessment
  3. 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: 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.

Your application will not enter into the next stage of processing until the application fee is paid.

10 working days

Assessment

Once your application has been receipted and the applicable fee paid, it will be progressed to the assessment stage and assigned to the next available assessor.

During the assessment process you may be required to provide further information about your application.

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

When the assessor has completed the assessment 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, or from third parties, the application clock will be stopped. The clock will restart the next full working day after the full response to the request for information is received.

Requests for information and response due dates

If further information is required you will be contacted, usually by email.

All written requests for information will include a due date. Where such a request is made under section 14J of the ND Act (a 14J request), a failure to provide the information requested 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.

Changes to applications by the applicant following submission

Applicants should only submit applications when they are confident that they have all required information and documents. The ODC recognises that in exceptional circumstances applicants may need to make minor corrections or changes to an application once submitted. These should be notified to the ODC as soon as practicable. Significant changes to application documents will require applications to be withdrawn, and a new application made. The original application fee cannot be transferred or refunded.

Minor changes

A minor change to an application that has been submitted 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)

Significant changes

Significant changes to an application that has been submitted may include:

  • Change of site location
  • Expansions to sites
  • Changes to building or security plans

Significant changes to applications are not accepted. If changes of the above kind have occurred, the application should be withdrawn, and a new application made with the new information included.

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.

Outline of permit and variation application process

Permit applications

Once a medicinal cannabis licence is granted, a permit is required before a licensee can commence cultivation, production or manufacturing activities. The permits are based on a 'one permit, per activity, per site' model.

At a minimum, permits will specify the quantities of plants or drugs to be obtained, cultivated or manufactured and the total quantities that may be held at any given time.

Permit applications will be assessed in three stages:

  1. Application receipt
  2. Assessment
  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 permit applications will be affected by a number of factors. Consideration of the quantities to be cultivated or manufactured will be given when assessing 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 than those applied for.

Changes to permit applications by the applicant following submission

You may not change your permit application once submitted, unless agreed in writing by the ODC.

Expiry of permits

All permits have an expiry date. Your licence may also have more than one permit activity per site.

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 request a variation to your current licence or permit, rather than having to apply for a new licence or permit.

A licence or permit variation can be made for various purposes, as defined by the variation ‘type’. For licences, there are 4 categories or ‘types’ of variations – type 1, 2, 3 and 4. For permits, there are 3 types of variations – type 1, 2 and 3 that apply to vary both a cultivation and production permit and a manufacture permit.

Note: Please note that each selected variation type and associated changes will attract separate fees.

Application fees are payable for each application for a licence or permit, or for each variation for a specified purpose, as set out below and on our Guidance: Fees and charges webpage. Licence/permit variations for various specified purposes have been grouped into a variation ‘type’ where the cost of the specified variations are similar, but each specified variation within that type attracts the relevant fee. Accordingly, where a licence holder applies for more than one specified variation, the total cost will be the cumulative amount of the applicable fees for each of the specified variations applied for. 

Medicinal cannabis licence variations:

Licence variation type 1, means a variation for any of the following purposes:

  • a change to the name of the licence holder (without changing the legal entity); or
  • remove authorised persons from the licence

Licence variation type 2, means a variation for any of the following purposes:

  • a change to the name of the licence holder (without changing the legal entity); or
  • changes in relation to the currently approved system of security for a particular licensed premises; or
  • any other variation not listed in licence variation type 1, type 3, or type 4

Licence variation type 3, means a variation for any of the following purposes:

  • changes in the layout of a site for a particular licensed premises; or
  • changes in the floorplan of a particular licensed premises; or
  • changes of authorised activities; or
  • adding an authorised person

Licence variation type 4, means a variation for the following purpose:

  • adding an additional site to an existing licence (inclusive of all variations required)

Medicinal cannabis permit variations:

Permit variation type 1, means a variation for any of the following purposes:

  • change the name of the licence holder on permit (without changing the legal entity); or
  • change to maximum quantities held at any one time (without increasing total authorised quantities within the current permit period)

Permit variation type 2, means a variation for any of the following purposes:

  • add or remove supply pathway(s)

Permit variation type 3, means a variation for any of the following purposes:

  • change to total authorised quantities within the current permit period; or
  • change to authorised activities

If you wish to make a request for a variation, all requests must be in writing and on the correct form and include the licence or permit number to be varied. Visit our licences and permits listed by type page, to work out what type of form you need to use. 

Significant amendments to variation applications may require additional evaluation time each time a request is made, or may require an application for a different variation type. Depending on the complexity of the amendment(s), you may be required to withdraw your application and reapply.

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. An invoice will be generated for any applicable variation fee and the application will not be progressed until the fee has been paid.

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

Assessment

A licence variation can be made for numerous purposes, as defined by the variation type.

Some types of permit variations may also require a licence variation.

Significant amendments to variation applications may require additional evaluation time each time a request is made.

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

60 working days for following receipt of payment for type 1 licence variations*

Up to 195 working days following receipt of payment for type 2, type 3, type 4 licence variations*

The above timeframes include decision.

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, including further information required from the applicant.

You will be formally notified when a decision is made.

Time included in the evaluation working days.

* Note: processing times are tracked by an application clock. If information has been requested from you, or from third parties, the application clock will be stopped. The clock will restart the next full working day after the full response to the request for information is received.

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, fees and charges, and application forms:
  • 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.

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