Summary

Amends the:

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 and to enable health practitioners to supply certain therapeutic goods not on the Australian Register of Therapeutic Goods to patients under a notification scheme.