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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

Note: that for minor and major variations a fee will be required.

Variations will either be of a minor* or major nature. Any variations that are not defined by the Narcotic Drugs Regulation 2016 (the Regulation) as minor are considered to be major variations. Minor variations are defined in the Regulation as follows:

minor licence variation, means a variation to:

1. if the licence specifies a period for which the licence is in force--the period for which the licence is in force; or
2. remove a person specified by the licence as a person who is authorised by the licence to engage in the activities authorised by the licence; or
3. if the licence holder is a body corporate and the body's name changes--update the name of the licence holder.

minor permit variation, means a variation to:

1. if the permit specifies the size of the cannabis crop that may be cultivated--reduce the size of the cannabis crop that may be cultivated; or
2. if the permit specifies the types of cannabis plants that may be cultivated--the number of each type of cannabis plant that may be cultivated provided the variation does not increase the total number of cannabis plants that:
   1. are of a type that has a higher level of tetrahydrocannabinol; and
   2. could be cultivated under the permit before the proposed variation.

Examples of major licence variations

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

Examples of major permit variations

• Increase to cultivation/ production or manufacture authorised totals
• Change in permitted activities
• Change in permitted activities
• Change in supply pathways

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.

Significant amendments to variation applications may require additional evaluation time of up to 195 working days for licences or 60 working days for permits each time a request is made. 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.

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:
  • Email mcs@health.gov.au
  • Phone 02 6289 4618 (option 3)
• For questions about invoicing:
  • Email MCS.application@health.gov.au
  • Phone 02 6289 4618 (option 2)
• For queries about permits and variations to existing licences:
  • Email mcs@health.gov.au
  • Phone 02 6289 4618 (option 4)

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.