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Rules/Other as made
This instrument amends the Therapeutic Goods (Medicines—Authorised Supply) Rules 2020 and Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020 to authorise the supply of specified medicines and kinds of medical devices by specified health practitioners where certain conditions are met, and makes a number of corrections and clarifications.
Administered by: Health and Aged Care
Registered 10 Feb 2022
Tabling HistoryDate
Tabled HR14-Feb-2022
Tabled Senate28-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Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003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 (Authorised Supply) Amendment (Medicines and Medical Devices) Rules 2022

I, Jane Cook, as delegate of the Minister for Health and Aged Care, make the following rules.

Dated 9 February 2022

Dr Jane Cook

Chief Medical Adviser
Health Products Regulation Group
Department of Health

 


Contents

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

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

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

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

Schedule 1—Amendments                                                                                           2

Part 1—Medicines                                                                                                   2

Therapeutic Goods (Medicines—Authorised Supply) Rules 2020                                               2

Part 2—Medical devices                                                                                          3

Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020                                   3

 

 


1  Name

                   This instrument is the Therapeutic Goods (Authorised Supply) Amendment (Medicines and Medical Devices) Rules 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.  The whole of this instrument

The day after this instrument is registered.

 

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 subsections 19(7A) and 41HC(6) of 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 1Amendments

Part 1Medicines

Therapeutic Goods (Medicines—Authorised Supply) Rules 2020

1  Schedule 1 (table item 1)

Repeal the item.

2  Schedule 1 (table items 10 and 11)

Repeal the items.

3  Schedule 1 (before table item 12)

Insert:

11A

ciclosporin, 0.05%

eye drops, emulsion

ophthalmic

treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)

4  Schedule 1 (after table item 16)

Insert:

16A

colecalciferol

capsule

oral

treatment of severe vitamin D deficiency and prevention of osteoporosis

16B

colecalciferol

injection

intramuscular

treatment of severe vitamin D deficiency and prevention of osteoporosis

5  Schedule 1 (table item 18)

Repeal the item.

6  Schedule 1 (after table item 26)

Insert:

26A

disulfiram

tablet

oral

deterrent to alcohol consumption

7  Schedule 1 (after table item 40)

Insert:

40A

iloprost

injection

intravenous infusion

treatment of patients with severe disabling Raynaud’s phenomenon; or

treatment of peripheral ischaemia

8  Schedule 1 (after table item 42)

Insert:

42A

interferon alpha-2b

eye drops

ophthalmic

treatment of ocular surface squamous neoplasia

9  Schedule 1 (after table item 46)

Insert:

46A

lifitegrast

eye drops

ophthalmic

treatment of dry eye disease

10  Schedule 1 (after table item 62)

Insert:

62A

progesterone

injection

subcutaneous

treatment of progesterone deficiency

62B

progesterone in oil

injection

intramuscular

treatment of progesterone deficiency

11  Schedule 1 (after table item 71)

Insert:

71A

Technetium-99m (99m Tc) prostate specific membrane antigen (PSMA)-I&S

injection

intravenous

prostate cancer imaging study

Part 2—Medical devices

Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2020

12  Schedule 1 (table item 4)

Repeal the item.

13  Schedule 1 (before table item 5)

Insert:

4A

AltiVate Reverse Shoulder system – DJO Global

for arthroplasty of the shoulder

orthopaedic surgeon

14  Schedule 1 (table item 5, column 4)

Omit “medical practitioner”, substitute “general surgeon”.

15  Schedule 1 (table item 6, column 4)

Omit “medical practitioner”, substitute “obstetrics and gynaecology specialist”.

16  Schedule 1 (after table item 10)

Insert:

10A

Duraloc Acetabular Cup System – Hip Insert/Liner – Johnson & Johnson t/a DePuy Synthes

revision hip arthroplasty

orthopaedic surgeon

17  Schedule 1 (table item 11, column 4)

Omit “medical practitioner”, substitute “obstetrics and gynaecology specialist”.

18  Schedule 1 (table item 12, column 4)

Omit “medical practitioner”, substitute “obstetrics and gynaecology specialist”.

19  Schedule 1 (table item 13, column 4)

Omit “medical practitioner”, substitute “obstetrics and gynaecology specialist”.

20  Schedule 1 (table item 14, column 4)

Omit “medical practitioner”, substitute “plastic surgeon”.

21  Schedule 1 (table item 15, column 4)

Omit “medical practitioner”, substitute “plastic surgeon”.

22  Schedule 1 (table item 17, column 4)

Omit “medical practitioner”, substitute “obstetrics and gynaecology specialist”.

23  Schedule 1 (table item 21, column 4)

Omit “medical practitioner”, substitute “cardiothoracic surgeon”.

24  Schedule 1 (table item 22)

Repeal the item.

25  Schedule 1 (table item 23)

Repeal the item.

26  Schedule 1 (table item 26, column 2)

Omit “Durasel”, substitute “Durasul PE”.

27  Schedule 1 (after table item 31)

Insert:

31A

Primetech Piezo Micro Manipulator and microinjection pipettes

in vitro fertilisation

obstetrics and gynaecology specialist

28  Schedule 1 (after table item 35)

Insert:

35A

Regeneten Bioinductive Implant – Bone Anchors with Anthroscopic Delivery System

rotator cuff surgery

orthopaedic surgeon