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You are here Home Guidance and resources Resources Reference material 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 Form Approval under subsection 22E(2) of the Therapeutic Goods Act 1989 - forms for extension of Provisional determinations and Orphan Drug designations applications Therapeutic Goods (Provisional and Priority Determinations and Orphan Drug Designations) Approval of Application Form Approval 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. Topics Legislation