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THERAPEUTIC GOODS AMENDMENT (2022 MEASURES NO. 1) ACT 2023 (NO. 10, 2023) - NOTES

 

No. 10, 2023

 

 

 

 

 

  

  


Contents

1............. Short title............................................................................................ 1

2............. Commencement.................................................................................. 2

3............. Schedules........................................................................................... 3

Schedule 1--Mandatory reporting of adverse events involving medical devices                4

Therapeutic Goods Act 1989                                                                                     4

Schedule 2--Export only biologicals                                                                          8

Therapeutic Goods Act 1989                                                                                     8

Schedule 3--Decisions to give information gathering notices are not reviewable decisions         15

Therapeutic Goods Act 1989                                                                                   15

Schedule 4--Extension of time to pay amount under infringement notice             16

Therapeutic Goods Act 1989                                                                                   16

Schedule 5--Information gathering powers                                                        18

Therapeutic Goods Act 1989                                                                                   18

Schedule 6--Retention of seized things                                                                  23

Therapeutic Goods Act 1989                                                                                   23

Schedule 7--Reducing regulatory burden for therapeutic goods advertisers      24

Therapeutic Goods Act 1989                                                                                   24

Schedule 8--Use of restricted representations                                                   26

Therapeutic Goods Act 1989                                                                                   26

Schedule 9--Approval of importation or supply of substitutable medicine           27

Therapeutic Goods Act 1989                                                                                   27

Schedule 10--Release of information                                                                      30

Therapeutic Goods Act 1989                                                                                   30

Schedule 11--Reporting medicine shortages                                                      31

Therapeutic Goods Act 1989                                                                                   31

Schedule 12--Other amendments                                                                              35

Therapeutic Goods Act 1989                                                                                   35

 


Commonwealth Coat of Arms of Australia

 

 

Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023

No. 10, 2023

 

 

 

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

[Assented to 21 March 2023]

The Parliament of Australia enacts:

 

[Minister's second reading speech made in--

House of Representatives on 1 December 2022

Senate on 9 February 2023]

 

(128/22)

 



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