Federal Register of Legislation - Australian Government

Primary content

Regulations as made
This instrument amends the Therapeutic Goods Regulations 1990, the Narcotic Drugs Regulation 2018 and the Therapeutic Goods (Medical Devices) Regulations 2002, to support the safe use of extemporaneously-compounded medicinal cannabis products in Australia and make a small number of more minor amendments.
Administered by: Health and Aged Care
Registered 04 Mar 2022
Tabling HistoryDate
Tabled Senate28-Mar-2022
Tabled HR29-Mar-2022
Date of repeal 27 Sep 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022

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 03 March 2022

David Hurley

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health and Aged Care

 

 

 

  

  


Contents

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

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

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

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

Schedule 1—Extemporaneously‑compounded medicinal cannabis products             2

Narcotic Drugs Regulation 2016                                                                                                       2

Therapeutic Goods Regulations 1990                                                                                               2

Schedule 2—Minamata Convention on Mercury                                                                         3

Therapeutic Goods Regulations 1990                                                                                               3

Schedule 3—Other amendments                                                                                                             6

Therapeutic Goods (Medical Devices) Regulations 2002                                                             6

Therapeutic Goods Regulations 1990                                                                                               6

 


1  Name

                   This instrument is the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022.

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.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

The day after this instrument is registered.

5 March 2022

2.  Schedule 1

31 March 2022.

31 March 2022

3.  Schedule 2

The later of:

(a) the day after this instrument is registered; and

(b) the day on which the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 commence.

However, the provisions do not commence at all if the event mentioned in paragraph (b) does not occur.

7 March 2022

(paragraph (b) applies)

4.  Schedule 3

The day after this instrument is registered.

5 March 2022

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 following:

                     (a)  the Narcotic Drugs Act 1967;

                     (b)  the Therapeutic Goods Act 1989.

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 1Extemporaneously‑compounded medicinal cannabis products

  

Narcotic Drugs Regulation 2016

1  After paragraph 4B(b)

Insert:

                   (ba)  the supply of a cannabis drug to a person for the purposes of that person supplying an extemporaneously-compounded medicinal cannabis product (within the meaning of the Therapeutic Goods Regulations 1990) in accordance with the Therapeutic Goods Act 1989;

2  After paragraph 11(c)

Insert:

                    (ca)  the supply is for the purposes of that person supplying an extemporaneously-compounded medicinal cannabis product (within the meaning of the Therapeutic Goods Regulations 1990) in accordance with the Therapeutic Goods Act 1989;

Therapeutic Goods Regulations 1990

3  In the appropriate position in Part 9

Insert:

Division 18Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022

86  Extemporaneously‑compounded medicinal cannabis products

                   The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.

4  Schedule 5 (at the end of the cell at table item 6, column 2)

Add “or that are medicinal cannabis products”.

Schedule 2Minamata Convention on Mercury

  

Therapeutic Goods Regulations 1990

1  Before subregulation 48(1)

Insert:

Definitions

2  Subregulation 48(1)

Insert:

eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.

 

Eligible persons in relation to initial decisions

Item

Column 1

Initial decision

Column 2

Eligible person

1

initial decision not covered by another item of this table

a person whose interests are affected by the initial decision

2

decision to refuse to make a therapeutic goods (priority applicant) determination

the person who applied for the determination

3

decision to revoke a therapeutic goods (priority applicant) determination

the priority applicant specified in the determination

4

decision under regulation 10JE or 10JF to refuse to approve an application for approval

the person who applied for the approval

5

decision under regulation 10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury

the person specified in the approval

3  Subregulation 48(1) (at the end of the definition of initial decision)

Add:

Note:          See also subregulation (1AA) of this regulation.

4  After subregulation 48(1)

Insert:

       (1AA)  Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:

                     (a)  a decision to refuse to approve an application for approval;

                     (b)  a decision to revoke or vary an approval.

Delegation

5  Before subregulation 48(2)

Insert:

Requests for reconsideration of initial decisions

6  Subregulation 48(2)

Omit “A person whose interests are affected by”, substitute “An eligible person in relation to”.

7  Subregulation 48(2AA)

Repeal the subregulation.

8  Before subregulation 48(3)

Insert:

Reconsideration of initial decisions

9  Before subregulation 48(6)

Insert:

Notices about right to seek reconsideration of initial decisions

10  Subregulation 48(6)

Omit “whose interests are affected by” (first occurring), substitute “who is an eligible person in relation to”.

11  Subregulation 48(6)

Omit “a person whose interests are affected by the decision” (second occurring), substitute “the person”.

12  Before subregulation 48(7)

Insert:

Failure to comply with subregulations (5) and (6) does not affect decisions

13  Before subregulation 48(8)

Insert:

Applications for review of reviewable decisions

14  In the appropriate position in Part 9

Insert:

Division 19Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022

87  Reconsideration of decisions

                   The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.

Schedule 3Other amendments

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  Subclause 13A.2(2) of Schedule 1 (table item 1, column headed “Information”, paragraph (c))

Omit “; and”.

2  Subclause 13A.2(2) of Schedule 1 (table item 1, column headed “Information”, paragraph (d))

Repeal the paragraph.

3  Dictionary (definition of unique device identifier)

Repeal the definition.

Therapeutic Goods Regulations 1990

4  Subregulation 12A(1)

Omit “the 9th Schedule to the Poisons Standard, as in force from time to time”, substitute “Schedule 9 or 10 to the Poisons Standard”.