We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
You are here Home Product regulation Regulations for all products Legislation and legislative instruments Instruments Section 22 instruments Last updated 2 May 2018 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... The following instruments are made under section 22 of the Therapeutic Goods Act 1989.Therapeutic Goods (Provisional Determinations and Orphan Drug Designations – Extension) Approval of Application FormApproval under subsection 22E(2) of the Therapeutic Goods Act 1989 - forms for extension of Provisional determinations and Orphan Drug designations applicationsTherapeutic Goods (Provisional and Priority Determinations and Orphan Drug Designations) Approval of Application FormApproval under section 22C the Therapeutic Goods Act 1989 for a provisional determination and regulation 16H of the Therapeutic Goods Regulations 1990 for all orphan drug designation and regulation 16Q of the Therapeutic Goods Regulations 1990 for a therapeutic goods (priority applicant) determination. Product types Biologicals Medical devices Medicines Unapproved therapeutic goods Boundary and combination products Topics Legislation Main navigation