19 October 2018

The following information outlines the application process under the Narcotic Drugs Act 1967 (ND Act). Licences or permits required under the ND Act should not be confused with any licences (e.g. manufacture) or permissions required under the Therapeutic Goods Act 1989 (TG Act).

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

The Office of Drug Control (ODC) is increasing resources allocated to application processing under the ND Act. Part of this process includes a new screening assessment which will ensure any significant issues with applications are identified shortly after application receipt.

The following information describes the new process and processing times based on current resource allocations and business processes. It is expected that application processing times will reduce as new resources come online.

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

ODC draws upon sources such as law enforcement agencies and a range of state, territory and Commonwealth agencies in reviewing applications, particularly in relation to the fit and proper person assessment. As a result, some applications can take significantly longer to process and we are endeavouring to ensure applications are being processed as quickly as practicable.

Note concerning TGA and GMP licences

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

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. Licence to manufacture narcotic drugs (including from cannabis*).

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

Process summary

Licence applications will undergo four stages:

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

At a minimum you will receive a notification when your licence application enters evaluation.

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.

Applications for licences and permits are processed in the order they are received.

Due to the shorter processing times, you may not be contacted on the status of permit applications.

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 formal requests for information will include a due date. If you do not meet the deadlines to provide information, your application may be referred to the decision maker to consider refusal.

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

Each licence type requires a separate decision under the ND Act.

A decision to grant a medicinal cannabis licence does not imply that a similar decision will be made for a manufacture licence and vice versa. Equally, if a decision is made to refuse a medicinal cannabis licence, it does not necessarily mean the manufacture licence will be refused.

If you are intending to cultivate and manufacture medicinal cannabis, on occasion you may receive similar requests for information during the evaluation process. If you have already provided documents or information, you may reference previous submissions. Please ensure you provide dates and reference numbers for previously submitted information to avoid processing delays.

Decision on fit and proper status

The ND Act requires a decision be made on the fit and proper status of the applicant. Matters are not limited to just the applicant or licence holder themselves but include connections and business associates.

If a decision is made that a person is not fit and proper, this will affect any application in progress or existing licences and permits associated with that person.

It is a breach of the licence if the licence holder does not notify this office on any matter (including not disclosing any relevant director, business associate or connection) that may affect whether the licence holder is fit and proper, or whether a business associate of the licence holder (in relation to a business of the licence or any other business) is a fit and proper person to be associated with the holder of such a licence.

A breach of the licence could result in a number of remedial actions, including, but not limited to, directions, suspension of activities or licence revocation.

Changes to applications by the applicant following submission

Licence Screening: If a change is made by the applicant while the application is undergoing screening, then the screening clock will be reset to 10 days.

Licence Evaluation: If a change is required by the applicant while the application is undergoing screening, then a minimum of 10 working days will be added each time a change is made. Major changes to applications may require the application clock to be restarted and your application returned to screening.

Permits: You may not change your application. You must submit a new application.

Expiry of licences and permits

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

In most cases you will be required to submit a new licence application (which includes a new fit and proper person assessment).

Outline of licence process

Process Processing time

Application receipt

  • Check that application form has been completed
  • Check that a data package has been provided for each licence type requested
  • Generation of invoice for fees (if applicable)
  • Receipt of fees (if applicable)

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

If any of the above is missing or incomplete your application may not be accepted and will not enter the next stage of processing (you will need to resubmit a new application if you still seek a licence under the ND Act).

5 working days

Screening

  • Review of the information provided for each licence type

This process reviews your application to ensure that information and documents meet legislative requirements and guidelines.

You will be requested to provide further information if your application is incomplete. If, following requests for information, your application is still incomplete (including failure to respond to requests) your application will be referred to the decision maker to consider refusal.

You will be notified when you application has entered evaluation.

10 working days

Evaluation

Your application will be split into the relevant sections for evaluation by an assessor.

  1. Cultivation/production licence evaluation
  2. Manufacture licence evaluation
  3. Fit and proper person evaluation

These three processes are performed concurrently. You may be required to provide further information about your application. If requested information is not provided your application may be referred to the decision maker to consider refusal.

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

195 working days (includes decision)

Applicant requested change to application (minor): add 10 working days for each request.

Applicant requested change to application (major): Application clock will be reset. e.g. +10 days (screening) + 195 working days (evaluation)

Decision

The decision maker will review the report prepared by the evaluator and determine whether to grant a licence.

The decision maker may refer the report back to the evaluator for more information.

You will be formally notified when a decision is made.

Time included in the evaluation working days

Contacting this office

Ensure all emails or correspondence starts with your application, licence or permit reference number. Incorrect or missing reference numbers will result in processing delays.

Note: We are only able to discuss applications with persons nominated in your application form.

If sending information by email, ensure your use the correct email address specified on the request letter.