27 July 2020

Introduction

The Narcotic Drugs Regulation 2016 (the Regulation) prescribes fees for various applications relating to medicinal cannabis made under the Narcotic Drugs Act 1967 (the Act).

Attachment A is what the Regulation defines as the 'variation application classification document'; it is the Specification of variation applications published on the Department's website. It specifies whether a kind of licence or permit variation application is either a simple application and, by exclusion from this type of application, what we are calling complex variation to work with the Regulation to determine what fee is payable for such a variation application. Those fees are set out in items 4, 5, 6 and 7 of the table in clause 1 of schedule 1 of the Regulation.

The fee you are required to pay when you make a variation application is set out in the Regulation as follows:

  • Simple licence variation applications are subject to a fee of $1,090, on the basis that the assessment of these applications will not require significant effort on behalf of officers of the department to assess.
  • Complex licence variation applications are subject to a fee of $5,460, on the basis that the assessment of such applications will require significant effort on behalf of officers of the department to assess.
  • Simple permit variation applications are subject to a fee of $120, on the basis that the assessment of these applications will not require significant effort on behalf of officers of the department to assess.
  • Complex permit variation applications are subject to a fee of $2,870, on the basis that the assessment of these applications will require significant effort on behalf of officers of the department to assess.

As manufacture licences and permits do not attract fees, this document is only relevant to applications to vary the following licence types and permits associated with those licence types

  • Medicinal cannabis licences
  • Cannabis research licences.

Notes

An application for variation of a permit is not a substitute for an application for a new permit. Applicants intending to apply for a complex permit variation should first contact MCS.Application@health.gov.au to determine if a new application is required.

This Specification of variation applications works with the 2020 amendments to the Regulation to determine the circumstances in which prescribed fees are payable. The ODC is presently carrying out a reform project focussed on the efficiency and effectiveness of the permit system. Stakeholders will be consulted on any proposals, which is likely to be in late 2020 after which government will consider possible reforms.

ATTACHMENT A - SPECIFICATION OF VARIATION APPLICATIONS

Application to vary a licence

Simple licence variation application

For the purposes of item 4 of the table in clause 1 of schedule 1 of the Narcotic Drugs Regulation 2016 (the Regulation), an application to vary a medicinal cannabis licence or a cannabis research licence granted under the Narcotic Drugs Act 1967 (the Act) set out in in Table 1 below is specified as a simple application.

Table 1: Applications to vary a licence - simple
1

Application to vary the period for which a medicinal cannabis licence or cannabis research licence is in effect.

2

Application to add or remove persons authorised by the licence to engage in activities authorised by the licence, but only if those persons do not also need to be assessed as a fit and proper person.

3

Application to vary the trading name of the licence holder.

Note: The ABN/ACN of the licence holder must remain the same.

'Complex' licence variation application

For the purposes of item 5 of the table in clause 1 of schedule 1 of the Regulation, an application to vary a medicinal cannabis licence or a cannabis research licence granted under the Act that is not specified in Table 1 above is specified as an application other than simple; for ease of reference such an application is known as a complex application.

Application to vary a permit

Simple permit variation applications

For the purposes of item 6 of the table in clause 1 of schedule 1 of the Regulation, an application to vary a medicinal cannabis permit or a cannabis research permit granted under the Act listed in Table 2 below is specified as a simple application.

Table 2: Application to vary a permit - simple
1

Application to vary any period specified on a medicinal cannabis permit or cannabis research permit is in force, but only if that application does not require a variation to any other aspect of the permit.

Note: It is expected that such applications would be required to allow for a time-limited continuation of authorised activities.

2

Application to vary the trading name of the licence holder, but only if that application does not require a variation to any other aspect of the permit.

Note: The ABN/ACN of the licence holder must remain the same.

3

Application to vary the maximum size of one or more cannabis crops that may be cultivated under the permit, provided that none of the following exceeds the maximum specified in the permit as in force at the time the application was made:

  1. the number of cannabis plants in the holder's possession or control at any time
  2. the quantity of cannabis or cannabis resin that may be produced
  3. the quantity of cannabis or cannabis resin that the licence holder has in its possession or control at any time.

'Complex' permit variation applications

For the purposes of item 7 of the table in clause 1 of schedule 1 of the Regulation, an application to vary a medicinal cannabis permit or a cannabis research permit granted under the Act that is not listed in Table 2 above is as an application other than simple; for ease of reference such an application is known as a complex application.