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Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

2016-2017

 

The Parliament of the

Commonwealth of Australia

 

HOUSE OF REPRESENTATIVES

 

 

 

 

Presented and read a first time

 

 

 

 

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

 

No.      , 2017

 

(Health)

 

 

 

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............................................................................................ 3

Schedule 1—Provisional registration of medicine                                               4

Therapeutic Goods Act 1989                                                                                      4

Schedule 2—Indications and ingredients for listed medicines                   15

Part 1—Amendments                                                                                                   15

Therapeutic Goods Act 1989                                                                                    15

Part 2—Application and transitional provisions                                             25

Schedule 3—New pathway for listed medicines                                                 28

Therapeutic Goods Act 1989                                                                                    28

Schedule 4—Preliminary assessment of applications                                      38

Part 1—Therapeutic goods                                                                                        38

Therapeutic Goods Act 1989                                                                                    38

Part 2—Biologicals                                                                                                        46

Therapeutic Goods Act 1989                                                                                    46

Part 3—Medical devices                                                                                             50

Therapeutic Goods Act 1989                                                                                    50

Part 4—Consequential amendments                                                                     55

Therapeutic Goods Act 1989                                                                                    55

Schedule 5—Conformity assessment procedures and certificates          56

Therapeutic Goods Act 1989                                                                                    56

Schedule 6—Advertising                                                                                                   74

Part 1—Enforcement                                                                                                    74

Therapeutic Goods Act 1989                                                                                    74

Part 2—Removal of requirement for advertisements to be approved 106

Broadcasting Services Act 1992                                                                            106

Therapeutic Goods Act 1989                                                                                  106

Schedule 7—Enforcement                                                                                             109

Therapeutic Goods Act 1989                                                                                  109

Schedule 8—Record-keeping etc.                                                                              184

Therapeutic Goods Act 1989                                                                                  184

Schedule 9—Other amendments                                                                                186

Therapeutic Goods Act 1989                                                                                  186

 

 



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 (2017 Measures No. 1) Act 2017 .

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.  Schedules 1 and 2

The later of:

(a) 1 January 2018; and

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

 

3.  Schedule 3

Immediately after the commencement of the provisions covered by table item 2.

 

4.  Schedules 4 and 5

The later of:

(a) 1 January 2018; and

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

 

5.  Schedule 6, Part 1

Immediately after the commencement of the provisions covered by table item 4.

 

6.  Schedule 6, Part 2

The later of:

(a) 1 July 2018; and

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

 

7.  Schedule 7

Immediately after the commencement of the provisions covered by table item 4.

 

8.  Schedule 8

The later of:

(a) 1 January 2018; and

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

 

9.  Schedule 9

Immediately after the commencement of the provisions covered by table item 5.

 

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.