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Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013

2013-2014

 

The Parliament of the

Commonwealth of Australia

 

HOUSE OF REPRESENTATIVES

 

 

 

 

As passed by both Houses

 

 

 

 

 

 

 

 

 

Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2014

 

No.      , 2014

 

 

 

 

 

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............ Schedule(s)......................................................................................... 2

Schedule 1—Advertising etc.                                                                                            3

Therapeutic Goods Act 1989                                                                                      3

Schedule 2—Obtaining information etc.                                                                 10

Therapeutic Goods Act 1989                                                                                    10

Schedule 3—Goods that are not therapeutic goods                                          14

Therapeutic Goods Act 1989                                                                                    14

Schedule 4—Restricted representations and prohibited representations                 17

Therapeutic Goods Act 1989                                                                                    17

Schedule 5—Evaluation and registration of therapeutic goods                18

Therapeutic Goods Act 1989                                                                                    18

Schedule 6—Conditions                                                                                                    23

Therapeutic Goods Act 1989                                                                                    23

Schedule 7—Presentation                                                                                                 27

Therapeutic Goods Act 1989                                                                                    27

Schedule 8—Consent to the import, supply or export of goods               28

Therapeutic Goods Act 1989                                                                                    28

Schedule 9—Review of decisions                                                                                 29

Therapeutic Goods Act 1989                                                                                    29

Schedule 10—Kits                                                                                                                 30

Therapeutic Goods Act 1989                                                                                    30

Schedule 11—False or misleading statements                                                      31

Therapeutic Goods Act 1989                                                                                    31

Schedule 12—Notice of cancellation of registration or listing                    33

Therapeutic Goods Act 1989                                                                                    33

Schedule 13—Publication etc.                                                                                        34

Therapeutic Goods Act 1989                                                                                    34

Schedule 14—Auditing applications                                                                          38

Therapeutic Goods Act 1989                                                                                    38

Schedule 15—Failure to comply with requirements to provide information etc.                 39

Therapeutic Goods Act 1989                                                                                    39

Schedule 16—Other amendments                                                                               41

Therapeutic Goods Act 1989                                                                                    41

 



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 may be cited as the Therapeutic Goods Amendment (2013 Measures No. 1) Act 2014 .

2   Commencement

                   This Act commences on the day this Act receives the Royal Assent.

3   Schedule(s)

                   Each Act 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.