Appendix D: Summary of major amended requirements made in TGO 91/92 as a result of 2015 targeted consultation Requirement TGO 91/92 Issue Current (Oct 2015 draft) (Feb 2016) Section 6 Definition of small container – 25 mL TGO 92: Section 6 Industry has identified A ‘medium’ size is currently being re-drafted for TGO containers greater than 92 with a capacity of 25-60mL, and smaller text size 25mL that would need text requirements (2.5 mm on main label and 2.0mm on size concessions as per side/rear panel). Active ingredients can be presented current ‘small containers’. on one line rather than on separate lines on the main label. Transition period to allow update for TGO 91 & 92: Section 6 Some submissions maintain Maintained. change in sponsorship/distributor that this is not sufficient Change to labels must details time, others that the be made within proposed period is too long. 12 months Section 7 AUST L/AUST R number in the TGO 91 & 92: 7(2)(d) Some stakeholders Maintained. Regulations and not duplicated in the requested that the Orders TGOs. explicitly refer to the inclusion of AUST R/AUST L on the label.
Appendix D: Summary of major amended requirements made in TGO 91/92 as a result of 2015 targeted consultation Requirement TGO 91/92 (Oct 2015 draft) Issue Current (Feb 2016) Section 6 Definition of small container – 25 mL TGO 92: Section 6 Industry has identified containers greater than 25mL that would need text size concessions as per current ‘small containers’. A ‘medium’ size is currently being re-drafted for TGO 92 with a capacity of 25-60mL, and smaller text size requirements (2.5 mm on main label and 2.0mm on side/rear panel). Active ingredients can be presented on one line rather than on separate lines on the main label. Transition period to allow update for change in sponsorship/distributor details TGO 91 & 92: Section 6 Change to labels must be made within 12 months Some submissions maintain that this is not sufficient time, others that the proposed period is too long. Maintained. Section 7 AUST L/AUST R number in the Regulations and not duplicated in the TGOs. TGO 91 & 92: 7(2)(d) Some stakeholders requested that the Orders explicitly refer to the inclusion of AUST R/AUST L on the label. Maintained.