Federal Register of Legislation - Australian Government

Primary content

Regulations as made
These regulations amend the Therapeutic Goods Regulations 1990 to permit the import and supply of unapproved goods that can act as a substitute for medicines that are unavailable or in short supply in Australia and the Therapeutic Goods (Medical Devices) Regulations 2002 to make equivalent amendments in respect of medical devices.
Administered by: Health
Registered 26 Apr 2018
Tabling HistoryDate
Tabled HR08-May-2018
Tabled Senate08-May-2018
Date of repeal 28 Apr 2018
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003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 (Exempt Devices and Goods) Regulations 2018

I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 19 April 2018

Peter Cosgrove

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

Therapeutic Goods (Medical Devices) Regulations 2002                                                             2

Therapeutic Goods Regulations 1990                                                                                               2

 


1  Name

                   This instrument is the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018.

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.

27 April 2018

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 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

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  In the appropriate position in Part 11

Insert:

Division 11.7Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018

11.34  Application of amendments

                   The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a medical device imported into Australia:

                     (a)  on or after the commencement of this regulation; or

                     (b)  during the 12 months ending immediately before that commencement, if the device was held under the direct control of the sponsor immediately before that commencement.

2  Part 2 of Schedule 4 (table item 2.1, column headed “Kinds of medical devices”, paragraph (b))

After “41HB”, insert “or 41HD”.

3  Part 2 of Schedule 4 (at the end of the cell at table item 2.1, column headed “Kinds of medical devices”)

Add:

; or (e) exported from Australia

4  Part 2 of Schedule 4 (table item 2.1, column headed “Conditions”, paragraph (c))

Repeal the paragraph.

5  Part 2 of Schedule 4 (table item 2.1, column headed “Conditions”, subparagraph (d)(ii))

Repeal the subparagraph.

Therapeutic Goods Regulations 1990

6  In the appropriate position in Part 9

Insert:

Division 8Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018

63  Application of amendments

                   The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:

                     (a)  on or after the commencement of this regulation; or

                     (b)  during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.

7  Schedule 5A (table item 1, column 2, paragraph (b))

Omit “or 32CK(1)”, substitute “, section 19A, subsection 32CK(1) or section 32CO”.

8  Schedule 5A (at the end of the cell at table item 1, column 2)

Add:

; or (e) exported from Australia

9  Schedule 5A (table item 1, column 3, paragraph (c))

Repeal the paragraph.

10  Schedule 5A (table item 1, column 3, subparagraph (d)(ii))

Repeal the subparagraph.