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.