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


Type
Government
Originating house
House of Representatives
Status
Before Reps
Portfolio
Health and Ageing

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; public notification and/or recall of registered or listed therapeutic goods, biologicals and medical devices; failure to comply with requirements to provide information; and specified information required for certain applications and requests.

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 20/03/13  
Second reading moved 20/03/13  
     

Links

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Text of bill

  • First reading

MS-Word PDF HTML

Explanatory memoranda

  • Explanatory memorandum

MS-Word PDF HTML

Second reading speeches


Proposed amendments

No proposed amendments have been circulated.

Schedules of amendments

Bills Digest



Notes
  • Referred to Committee (21/03/2013): Senate Community Affairs Legislation Committee; Report due 17/06/2013
  • Access information for House of Representatives and Senate committees