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Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020

2019-2020

 

The Parliament of the

Commonwealth of Australia

 

HOUSE OF REPRESENTATIVES

 

 

 

 

As passed by both Houses

 

 

 

 

Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020

 

No.      , 2020

 

 

 

 

 

 

A Bill for an Act to amend the Therapeutic Goods Act 1989 , and for related purposes

   

   



Contents

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

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

3............ Schedules............................................................................................ 2

Schedule 1—Medical devices                                                                                            3

Part 1—Medical device definitions                                                                        3

Therapeutic Goods Act 1989                                                                                      3

Part 2—Basis of certification of conformity assessment procedures     5

Therapeutic Goods Act 1989                                                                                      5

Part 3—Cancellation of entries of kinds of medical devices from the Register   6

Therapeutic Goods Act 1989                                                                                      6

Part 4—Medical device standards and conformity assessment standards              7

Therapeutic Goods Act 1989                                                                                      7

Schedule 2—Scientific advice about quality, safety and efficacy of medicine       8

Therapeutic Goods Act 1989                                                                                      8

Schedule 3—Variations to approved clinical trials                                           11

Therapeutic Goods Act 1989                                                                                    11

Schedule 4—Preliminary assessment of applications for variation of permissible ingredients determination                                                                                             15

Therapeutic Goods Act 1989                                                                                    15

Schedule 5—Approving supply of therapeutic goods under authorised prescriber scheme        20

Therapeutic Goods Act 1989                                                                                    20

Schedule 6—Removal of offences for person claiming to be able to arrange supply of therapeutic goods                                                                                                                             22

Therapeutic Goods Act 1989                                                                                    22

Schedule 7—Conditions of registration or listing of therapeutic goods 23

Therapeutic Goods Act 1989                                                                                    23

Schedule 8—Changes to provisionally registered medicine                        24

Therapeutic Goods Act 1989                                                                                    24

Schedule 9—Data protection for certain listed medicine                              29

Therapeutic Goods Act 1989                                                                                    29

Schedule 10—Other amendments                                                                               31

Patents Act 1990                                                                                                         31

Therapeutic Goods Act 1989                                                                                    31

 

 



A Bill for an Act to amend the Therapeutic Goods Act 1989 , and for related purposes

The Parliament of Australia enacts:

1   Short title

                   This Act is the Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 .

2   Commencement

             (1)  Each provision of this Act 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 3 and anything in this Act not elsewhere covered by this table

The day this Act receives the Royal Assent .

 

2.  Schedule 1, Part 1

The later of:

(a) 25 August 2020; and

(b) the 28th day after this Act receives the Royal Assent.

 

3.  Schedule 1, Parts 2 to 4

The day after this Act receives the Royal Assent.

 

4.  Schedules 2 to 4

The 28th day after this Act receives the Royal Assent.

 

5.  Schedules 5 to 10

The day after this Act receives the Royal Assent.

 

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

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

3   Schedules

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