Authorised Prescribers; and Importation for personal use. The figures below provide a graphic representation of these mechanisms and the sections of the Act and regulations relevant to their operation. The provisions specifically relating to the Special Access Scheme have been shaded. Access to unapproved medicines and OTGs Figure 1 Use in Clinical Trial Personal Importation Special Access Authorised Prescriber Subsection 18(1) Scheme Subsection 19(5) Reg 12(1) Subsection 31B(3) Schedule 5 item 1 Reg 12B CTN CTX Category A Category B Subsec 18(1) Section 19, Section 18 Section 19, esp Subsec 31A(1) esp 19(1)(b) Subsec 31A(2) 19(1)(a)* Reg 12 & Subsec 31B(1) Reg 12A Subsec 31B(1) Schedule 5A, & 31B(2) item 3 Regs TGA Authorised officers by external delegate Subsec 57(3) Reg 47A * Section 19 (1)(a) allows supply for Category A and Category B patients but, in practice, category A cases are dealt with under s18 and reg12A. Reg = Therapeutic Goods Regulations 1990 Access to unapproved medical devices Figure 2 Use in Clinical Trial Personal Importation Special Access Authorised Prescriber Section 41HA Scheme Section 41HC MDReg 7.1 & Section 41JF Schedule 4 item 1.1 MDReg 7.6, 7.7 CTN CTX Category A Category B Section 41HA Section 41HB Section 41HA Section 41HB Subsec 41JD(1) Section 41JE Section 41JD Subsec 41JE (1) MDReg 7.1 & MDRegs MDReg 7.2 Schedule 4, MDReg 8.2 item 2.3
Authorised Prescribers; and Importation for personal use. The figures below provide a graphic representation of these mechanisms and the sections of the Act and regulations relevant to their operation. The provisions specifically relating to the Special Access Scheme have been shaded. Figure 1 Access to unapproved medicines and OTGs Use in Clinical Trial Personal Importation Subsection 18(1) Reg 12(1) Schedule 5 item 1 Special Access Scheme Authorised Prescriber Subsection 19(5) Subsection 31B(3) Reg 12B CTN Subsec 18(1) Subsec 31A(1) Reg 12 & Schedule 5A, item 3 CTX Section 19, esp 19(1)(b) Subsec 31B(1) & 31B(2) Regs Category A Section 18 Subsec 31A(2) Reg 12A Category B Section 19, esp 19(1)(a)* Subsec 31B(1) TGA officers Authorised by external delegate Subsec 57(3) Reg 47A * Section 19 (1)(a) allows supply for Category A and Category B patients but, in practice, category A cases are dealt with under s18 and reg12A. Reg = Therapeutic Goods Regulations 1990 Figure 2 Access to unapproved medical devices Use in Clinical Trial Personal Importation Section 41HA MDReg 7.1 & Schedule 4 item 1.1 Special Access Scheme Authorised Prescriber Section 41HC Section 41JF MDReg 7.6, 7.7 CTN Section 41HA Subsec 41JD(1) MDReg 7.1 & Schedule 4, item 2.3 CTX Section 41HB Section 41JE MDRegs Category A Section 41HA Section 41JD MDReg 7.2 MDReg 8.2 Category B Section 41HB Subsec 41JE (1)
access-authorised-prescriber-guidelines.docx