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Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016


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

Summary

Amends the Therapeutic Goods Act 1989 to: enable certain variations that do not impact the quality, safety or efficacy of medicines to be made by notification to the Therapeutic Goods Administration (TGA); enable Australian designated bodies to undertake conformity assessment of manufacturers of medical devices; alter the requirements for the minister to consult with committees; provide review and appeal rights for persons applying to have new ingredients permitted for use in listed complementary medicines; enable priority approval of therapeutic goods, biologicals and medical devices; specify timeframes within which the secretary must complete actions or make decisions in relation to listed complementary medicines; amend record-keeping arrangements to assist with post-marketing monitoring of medicines and medical devices; provide further grounds on which applications to vary an entry in the register will not be considered to be effective; update terminology and provide for certain public notifications in relation to the recall of therapeutic goods; enable the secretary to obtain certain information from sponsors of listed medicines; and make miscellaneous amendments in relation to powers to approve unapproved goods in the event of a shortage, alignment of cancellation powers, revoking the cancellation of goods cancelled for non-payment of annual charges, information-gathering powers in relation to holders of manufacturing licences, and conditions of inclusion in the register of medical devices; and the A New Tax System (Goods and Services Tax) Act 1999 and Therapeutic Goods Act 1989 to enable health practitioners to supply certain therapeutic goods not on the Australian Register of Therapeutic Goods to patients under a notification scheme.

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 01/12/16  
Second reading moved 01/12/16  
     

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