Information required to be on a label 7(2)(e) Industry stakeholders have Maintained. must be in a colour or colours concern with subjectivity of Exemption for batch contrasting strongly with the ‘colour contrast’. number and expiry background. date details. Non-industry stakeholders have reiterated their concerns regarding this exemption. Section 8 Requirement for tabulated medicine TGO 92: 8(3) Requests for further Extend exemptions to all hand sanitisers and also information on registered exemptions toothpastes. Exemptions for certain medicines. lozenges, antacids, Requests for exemptions for anti-acne, anti-fungal, some hand sanitisers. corn and callus removers not accepted (for safety reasons). Options for identification of TGO 91: 8(1) Some submissions identify Maintained. declarable substances on labels of a concern that this Option for declaration Additional information to be provided to confirm that prescription and related medicines requirement results in the on the label OR there is not a new requirement for a package insert. need for a package insert. statement referencing CMI
Information required to be on a label must be in a colour or colours contrasting strongly with the background. 7(2)(e) Exemption for batch number and expiry date details. Industry stakeholders have concern with subjectivity of ‘colour contrast’. Non-industry stakeholders have reiterated their concerns regarding this exemption. Maintained. Section 8 Requirement for tabulated medicine information on registered medicines. TGO 92: 8(3) Exemptions for certain lozenges, antacids, some hand sanitisers. Requests for further exemptions Extend exemptions to all hand sanitisers and also toothpastes. Requests for exemptions for anti-acne, anti-fungal, corn and callus removers not accepted (for safety reasons). Options for identification of declarable substances on labels of prescription and related medicines TGO 91: 8(1) Option for declaration on the label OR statement referencing CMI Some submissions identify a concern that this requirement results in the need for a package insert. Maintained. Additional information to be provided to confirm that there is not a new requirement for a package insert.