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.
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