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Bill
- Schedule 1—Mandatory reporting of adverse events involving medical devices
- Schedule 2—Export only biologicals
- Schedule 3—Decisions to give information gathering notices are not reviewable decisions
- Schedule 4—Extension of time to pay amount under infringement notice
- Schedule 5—Information gathering powers
- Schedule 6—Retention of seized things
- Schedule 7—Reducing regulatory burden for therapeutic goods advertisers
- Schedule 8—Use of restricted representations
- Schedule 9—Approval of importation or supply of substitutable medicine
- Schedule 10—Release of information
- Schedule 11—Reporting medicine shortages
- Schedule 12—Other amendments
2022
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
No. , 2022
(Health and Aged Care)
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—Mandatory reporting of adverse events involving medical devices 3
Therapeutic Goods Act 1989 3
Schedule 2—Export only biologicals 7
Therapeutic Goods Act 1989 7
Schedule 3—Decisions to give information gathering notices are not reviewable decisions 14
Therapeutic Goods Act 1989 14
Schedule 4—Extension of time to pay amount under infringement notice 15
Therapeutic Goods Act 1989 15
Schedule 5—Information gathering powers 17
Therapeutic Goods Act 1989 17
Schedule 6—Retention of seized things 22
Therapeutic Goods Act 1989 22
Schedule 7—Reducing regulatory burden for therapeutic goods advertisers 23
Therapeutic Goods Act 1989 23
Schedule 8—Use of restricted representations 25
Therapeutic Goods Act 1989 25
Schedule 9—Approval of importation or supply of substitutable medicine 26
Therapeutic Goods Act 1989 26
Schedule 10—Release of information 29
Therapeutic Goods Act 1989 29
Schedule 11—Reporting medicine shortages 30
Therapeutic Goods Act 1989 30
Schedule 12—Other amendments 34
Therapeutic Goods Act 1989 34
A Bill for an Act to amend the Therapeutic Goods Act 1989 , and for related purposes
The Parliament of Australia enacts:
This Act is the Therapeutic Goods Amendment (2022 Measures No. 1) Act 2022 .
(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.
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Commencement information |
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Column 1 |
Column 2 |
Column 3 |
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Provisions |
Commencement |
Date/Details |
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1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table |
The day this Act receives the Royal Assent. |
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2. Schedule 1 |
A single day to be fixed by Proclamation. However, if the provisions do not commence within the period of 24 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period. |
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3. Schedule 2 |
The day after the end of the period of 3 months beginning on the day this Act receives the Royal Assent. |
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4. Schedules 3 to 10 |
The day after this Act receives the Royal Assent. |
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5. Schedule 11 |
The day after the end of the period of 6 months beginning on the day this Act receives the Royal Assent. |
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6. Schedule 12 |
The day after this Act receives the Royal Assent. |
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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.
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.