The Clause-based mapping document shows how the requirements in TGO 107 arose from TGO87 that sunset in October 2021.
For further information see:
| TGO107 | Sunsetting TGO 87 | Regulatory Requirement | Summary of change from current standard |
|---|---|---|---|
| Preliminary | |||
| 4 | 4 | No change | Definitions - Redrafted to clarify intent |
| 6 | 5(1) | Decrease | Exemption to 'Exempt Autologous HCT products' |
| General requirements | |||
| 8(1) | 6(2) | No change | No change |
| 8(2) | Not in standard | Increase | New - Clarifies that labels must be securely attached and appropriate to maintain integrity |
| 8(3) | 6(1) | No change | Redrafted to clarify intent |
| 8(4) | 5(2) | No change | No change |
| Labels of HCT materials | |||
| 9(1) | 6(3), 6(4) | No change | Redrafted to clarify intent |
| 9(2) | 6(5) | No change | Redrafted to clarify intent |
| 9(3) | Not in standard | Decrease | Exemption to 'HCT materials' not for supply in Australia |
| Labels of biologicals | |||
| 10(1) | 6(5 -8) | No change | Redrafted to clarify intent |
| 10(2) | Not in standard | Decrease | Exemption to 'HCT materials' not for supply in Australia |
| 10(3) | Not in standard | No change | New - Clarifies requirements of the order |
| Schedule 1 | |||
| Item 1 | 6(3)(a) | Decrease | Alternative of machine-readable codes |
| Item 2-5 | 6(3)(b -e) | No change | No change |
| Schedule 2 - Part 1 | |||
| Item 1 | 6(6)(a) | Decrease | Alternative of machine-readable codes |
| Item 2 | 6(6)(b) | No change | No change |
| Item 3 | 6(6)(c) | No change | No change |
| Item 4 | 6(6)(p) | No change | No change |
| Item 5 | Not in standard | Increase | New - Designated patient identifier for directed allogeneic Biologicals |
| Item 6 | 6(6)(d) | No change | No change |
| Item 7 | 6(6)(e) | No change | No change |
| ItemSchedule 2 - Part 2 | |||
| Item 1 | 6(6)(p) | No change | No change |
| Item 2 | Not in standard | Increase | New - Designated patient identifier for directed allogeneic Biologicals |
| Item 3 | 6(6)(d) | No change | No change |
| Item 3 | 6(6)(e) | No change | No change |
| Item 5 | 6(6)(f) | No change | No change |
| Item 6 | Not in standard | Increase | New - Approved indication - class 3 and 4 Biologicals only |
| Item 7 | Not in standard | Increase | New - intended use - class 1 and 2 Biologicals only |
| Item 8 | Not in standard | Increase | New - therapeutic use - Biologicals not included in the Register |
| Item 9 | 6(6)(g) | No change | No change |
| Item 10 | 6(6)(g) | No change | No change |
| Item 11 | 6(6)(h) | No change | No change |
| Item 12 | 6(6)(i) | No change | No change |
| Item 13 | 6(6)(k) | No change | No change |
| Item 14 | 6(6)(l) | No change | No change |
| Item 15 | 6(6)(m) | No change | No change |
| Item 16 | 6(6)(n) | No change | No change |
| Item 17 | Not in standard | Increase | New - instructions for preparation |
| Item 18 | 6(6)(r) | No change | No change |
| Item 19 | 6(6)(s) | No change | No change |
| Item 20 | 6(6)(s) | No change | No change |
| Item 21 | Not in standard | Increase | New - interactions |
| Item 22 | Not in standard | Increase | New - incompatibilities |
| Item 23 | Not in standard | Increase | New - Pregnancy, breastfeeding or impact on fertility warnings |
| Item 24 | Not in standard | Increase | New - Allergy warnings |
| Item 25 | Not in standard | Increase | New - effect on personal behaviours warnings |
| Item 26 | 6(6)(s) | No change | No change |
| Item 27 | Not in standard | Increase | New - instructions for adverse event reporting |
| Item 28 | 6(6)(t) | No change | No change |
| Item 29 | Not in standard | Increase | New - information on biochemical, biodynamic or biokinetic properties - class 3 and 4 only |
| Item 30 | Not in standard | Increase | New - information on clinical trials - class 3 and 4 Biologicals only |
| Item 31 | Not in standard | Increase | New - information on toxicology studies - class 3 and 4 Biologicals only |