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


Type
Government
Originating house
House of Representatives
Status
Act
Portfolio
Health

Summary

Amends the Therapeutic Goods Act 1989 to: enable the minister to specify products that are taken not to be therapeutic goods; enable the secretary to remove products that are not therapeutic goods from the Australian Register of Therapeutic Goods; clarify the secretary’s powers to approve product information for medicines accepted for registration in the register; and make amendments in relation to: compliance with advertising requirements; obtaining information and documents; use of restricted and prohibited representations in advertisements; conditions of registration or listing in the register; presentation of registered or listed goods; consent to the import, supply or export of goods; review of decisions; a package and its contents to constitute a kit; criminal offences and civil penalties for false or misleading statements in relation to variation requests; minimum notice period for cancellation of registration or listing in the register; secretary’s discretion to publish certain information on the department’s website; clarification of the merits review process; prescribing of alternative periods of time in relation to the secretary’s selection of an application for auditing; failure to comply with requirements to provide information; and revocation of requested cancellation of devices, licences or certificates.

Progress of bill

For committee reference information, please see the Notes section at the end of this page.

House of Representatives
Introduced and read a first time 12/12/13  
Second reading moved 12/12/13  
Second reading debate 11/02/14  
Second reading agreed to 11/02/14  
Consideration in detail debate 11/02/14  
Third reading agreed to 11/02/14  
     
Senate
Introduced and read a first time 12/02/14  
Second reading moved 12/02/14  
Second reading debate 13/02/14  
Second reading agreed to 13/02/14  
Third reading agreed to 13/02/14  
     
Text of bill as passed both Houses 13/02/14  
Assent 28/02/14 Act no.: 4 - Year: 2014
     

Text of bill

  • First reading

MS-Word PDF HTML
  • As passed by both Houses

MS-Word PDF HTML

Explanatory memoranda

  • Explanatory memorandum

MS-Word PDF HTML

Second reading speeches


Proposed amendments

House of Representatives
  • Non-Government
PARKE, Melissa, MP

MS-Word PDF HTML

Schedules of amendments

Bills Digest



Notes
  • An electronic version of this Act is available on the Federal Register of Legislation (www.legislation.gov.au)