Federal Register of Legislation - Australian Government

Primary content

Regulations as made
These regulations amend the Narcotic Drugs Regulation 2016 to provide for the extension of cost recovery to cannabis-related manufacture licences and permits, and to update fees.
Administered by: Health
Registered 20 Oct 2020
Tabling HistoryDate
Tabled HR21-Oct-2020
Tabled Senate09-Nov-2020
Date of repeal 16 Feb 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Narcotic Drugs Amendment (Cannabis‑Related Manufacture Licences and Permits) Regulations 2020

I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 15 October 2020

David Hurley

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

 

 

 

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Amendments                                                                                                                          2

Narcotic Drugs Regulation 2016                                                                                                       2

 


1  Name

                   This instrument is the Narcotic Drugs Amendment (Cannabis-Related Manufacture Licences and Permits) Regulations 2020.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 November 2020.

1 November 2020

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under the Narcotic Drugs Act 1967.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

  

Narcotic Drugs Regulation 2016

1  Section 4

Insert:

cannabis‑related licence means:

                     (a)  a cannabis licence; or

                     (b)  a cannabis‑related manufacture licence.

cannabis‑related manufacture licence means a manufacture licence that will authorise the manufacture of a drug that includes, or is from, any part of the cannabis plant.

cannabis‑related manufacture permit means a manufacture permit relating to the manufacture of a drug that includes, or is from, any part of the cannabis plant.

cannabis‑related permit means:

                     (a)  a cannabis permit; or

                     (b)  a cannabis‑related manufacture permit.

2  After paragraph 35(2)(f)

Insert:

                    (fa)  if the applicant seeks a decision of the Secretary under subsection 54AB(3) that the manufacturing that the applicant proposes to undertake under the licence is for, or primarily for, research for non‑commercial purposes—the following details about the manufacturing and research:

                              (i)  the primary purpose of the manufacturing and research;

                             (ii)  who will benefit from the manufacturing and research;

                            (iii)  how any products that may be developed as a result of the manufacturing and research will be used;

                            (iv)  the source of the funds for the manufacturing and research;

                             (v)  who owns or operates the manufacturing facilities in which the manufacturing and research will be undertaken;

3  After section 36

Insert:

36AA  Application fee for cannabis‑related manufacture licence

                   For the purposes of subsection 11G(3) of the Act, the application fee set out in the table in clause 1 of Schedule 1 for a cannabis‑related manufacture licence is prescribed.

4  At the end of Division 1 of Part 3

Add:

38A  Application fee for cannabis‑related manufacture permit

                   For the purposes of subsection 12(3) of the Act, the application fee set out in the table in clause 1 of Schedule 1 for a cannabis‑related manufacture permit is prescribed.

5  At the end of Subdivision A of Division 3 of Part 3

Add:

43A  Application fee for variation of cannabis‑related manufacture licence or permit

                   For the purposes of subsection 13A(2) of the Act, the application fee set out in the table in clause 1 of Schedule 1 for a variation of a cannabis‑related manufacture licence or cannabis‑related manufacture permit is prescribed.

6  At the end of section 52

Add:

                    ; (i)  a decision under subsection 54AA(3) about whether manufacturing that a licence holder undertakes is undertaken:

                              (i)  for research for non‑commercial purposes; or

                             (ii)  primarily for research for non‑commercial purposes;

                      (j)  a decision under subsection 54AB(3) about whether manufacturing that an applicant proposes to undertake will be undertaken:

                              (i)  for research for non‑commercial purposes; or

                             (ii)  primarily for research for non‑commercial purposes.

7  After section 54A

Insert:

54AA  Classes of cannabis‑related manufacture licences for the purposes of charge—licences granted on the basis of applications made before 1 November 2020

Application

             (1)  This section applies to a cannabis‑related manufacture licence if the licence was granted on the basis of an application made before 1 November 2020.

Commercial cannabis‑related manufacture licence

             (2)  For the purposes of paragraph 28(1)(e) of the Act, a cannabis‑related manufacture licence to which this section applies is a commercial cannabis‑related manufacture licence if the Secretary has not notified the holder of the licence in accordance with subsection (3).

Non‑commercial cannabis‑related manufacture licence

             (3)  For the purposes of paragraph 28(1)(e) of the Act, a cannabis‑related manufacture licence to which this section applies is a non‑commercial cannabis‑related manufacture licence if, on application by the licence holder, the Secretary notifies the holder in writing that the Secretary is reasonably satisfied that the manufacturing that the holder undertakes under the licence is undertaken:

                     (a)  for research for non‑commercial purposes; or

                     (b)  primarily for research for non‑commercial purposes.

Application for decision under subsection (3)

             (4)  An application by a licence holder for a decision of the Secretary under subsection (3) that the manufacturing that the applicant undertakes under the licence is for, or primarily for, research for non‑commercial purposes must:

                     (a)  be made in the form or manner approved in writing by the Secretary; and

                     (b)  include the following details about the manufacturing and research:

                              (i)  the primary purpose of the manufacturing and research;

                             (ii)  who benefits from the manufacturing and research;

                            (iii)  how any products that may be developed as a result of the manufacturing and research will be used;

                            (iv)  the source of the funds for the manufacturing and research;

                             (v)  who owns or operates the manufacturing facilities in which the manufacturing and research are undertaken.

Matters to which the Secretary must have regard

             (5)  In making a decision under subsection (3) about manufacturing that a licence holder undertakes, the Secretary must have regard to the matters mentioned in paragraph (4)(b).

Other matters

             (6)  Subsection (5) does not limit the matters to which the Secretary may have regard in making a decision under subsection (3).

54AB  Classes of cannabis‑related manufacture licences for the purposes of charge—licences granted on the basis of applications made on or after 1 November 2020

Application

             (1)  This section applies to a cannabis‑related manufacture licence if the licence was granted on the basis of an application made on or after 1 November 2020.

Commercial cannabis‑related manufacture licence

             (2)  For the purposes of paragraph 28(1)(e) of the Act, a cannabis‑related manufacture licence to which this section applies is a commercial cannabis‑related manufacture licence if, when granting the licence, the Secretary does not notify the applicant for the licence in accordance with subsection (3).

Non‑commercial cannabis‑related manufacture licence

             (3)  For the purposes of paragraph 28(1)(e) of the Act, a cannabis‑related manufacture licence to which this section applies is a non‑commercial cannabis‑related manufacture licence if, when granting the licence, the Secretary notifies the applicant for the licence in writing that the Secretary is reasonably satisfied that the manufacturing that the applicant proposes to undertake under the licence will be undertaken:

                     (a)  for research for non‑commercial purposes; or

                     (b)  primarily for research for non‑commercial purposes.

Matters to which the Secretary must have regard

             (4)  In making a decision under subsection (3) about manufacturing that an applicant proposes to undertake, the Secretary must have regard to the matters mentioned in paragraph 35(2)(fa).

Other matters

             (5)  Subsection (4) does not limit the matters to which the Secretary may have regard in making a decision under subsection (3).

8  In the appropriate position in Part 6

Insert:

60  Application provisions relating to the Narcotic Drugs Amendment (Cannabis‑Related Manufacture Licences and Permits) Regulations 2020

             (1)  The amendment of section 35 by the Narcotic Drugs Amendment (Cannabis‑Related Manufacture Licences and Permits) Regulations 2020 applies in relation to applications made on or after 1 November 2020.

             (2)  Sections 36AA, 38A and 43A apply in relation to applications made on or after 1 November 2020.

             (3)  The amendments of Schedule 1 by the Narcotic Drugs Amendment (Cannabis‑Related Manufacture Licences and Permits) Regulations 2020 apply in relation to applications made on or after 1 November 2020.

9  Schedule 1 (note to Schedule heading)

Omit “and 24”, substitute “, 24, 36AA, 38A and 43A”.

10  Clause 1 of Schedule 1 (table)

Repeal the table, substitute:

 

Application fees

Item

Column 1
Application

Column 2
Fee ($)

1

Application for a cannabis‑related licence, except an application covered by item 2 or 3

7,960

2

Applications made at the same time for:

(a) a medicinal cannabis licence and a cannabis research licence; or

(b) a medicinal cannabis licence and a cannabis‑related manufacture licence; or

(c) a cannabis research licence and a cannabis‑related manufacture licence;

that are to authorise activities at the same licensed premises

8,580
(total for both applications)

3

Applications made at the same time for:

(a) a medicinal cannabis licence; and

(b) a cannabis research licence; and

(c) a cannabis‑related manufacture licence;

that are to authorise activities at the same licensed premises

9,250
(total for all applications)

4

Application for a cannabis‑related permit

3,410

5

Application for a variation of a cannabis‑related licence that is a simple application according to the variation application classification document

1,090

6

Application for a variation of a cannabis‑related licence other than an application described in item 5

5,460

7

Application for a variation of a cannabis‑related permit that is a simple application according to the variation application classification document

120

8

Application for a variation of a cannabis‑related permit other than an application described in item 7

2,870