Labels of registered Concern regarding no TGO 92 has been amended to medicines must definition of ‘MIP’. reflect a move away from provide information in a prescriptive ‘box/panel Request for clarity on the consistent order and manner. presentation.’ degree of flexibility allowed, especially inclusion of ‘other Reference is now made to information’. ‘critical health information (CHI)’ rather than a ‘panel’. CHI has been defined in section 6. Medicine Information Panel Industry stakeholders Extend exemptions to all hand (MIP) requirements for requested further exemptions sanitisers and also medicines for certain lozenges, antacids, toothpastes. some hand sanitisers. Note: now Display of critical Requests for exemptions for health information anti-acne, anti-fungal, corn and callus removers not accepted (for safety reasons). Criteria for exemptions was combination of pack size (overdose risk), low risk actives and intended use (no 'course of treatment', occasional relief/symptomatic relief. Medicine name to be on at Removal of this requirement Maintained. Reiterating the least 3 sides of a carton from TGO 92 has raised same information on multiple concerns with some sides of the carton would stakeholders. clutter important health information on medicines. Small containers The majority of industry Exemption for small submissions detailed concerns containers has been included about the requirements for where multiple actives can be small containers (defined as on the same line and smaller 25mL or less) relating to font minimum text size used for sizes, existing information active ingredients on labels of requirements and impact on small containers that do not package size especially re the have outer packaging. proposed MIP. A number of respondents proposed a redefinition of ‘small container’, even up to 100mL.
Labels of registered medicines must provide information in a consistent order and manner. Concern regarding no definition of ‘MIP’. Request for clarity on the degree of flexibility allowed, especially inclusion of ‘other information’. TGO 92 has been amended to reflect a move away from prescriptive ‘box/panel presentation.’ Reference is now made to ‘critical health information (CHI)’ rather than a ‘panel’. CHI has been defined in section 6. Medicine Information Panel (MIP) requirements for medicines Note: now Display of critical health information Industry stakeholders requested further exemptions for certain lozenges, antacids, some hand sanitisers. 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). Criteria for exemptions was combination of pack size (overdose risk), low risk actives and intended use (no 'course of treatment', occasional relief/symptomatic relief. Medicine name to be on at least 3 sides of a carton Removal of this requirement from TGO 92 has raised concerns with some stakeholders. Maintained. Reiterating the same information on multiple sides of the carton would clutter important health information on medicines. Small containers The majority of industry submissions detailed concerns about the requirements for small containers (defined as 25mL or less) relating to font sizes, existing information requirements and impact on package size especially re the proposed MIP. A number of respondents proposed a redefinition of ‘small container’, even up to 100mL. Exemption for small containers has been included where multiple actives can be on the same line and smaller minimum text size used for active ingredients on labels of small containers that do not have outer packaging.
General-requirements-for-labels-for-medicines-RIS.docx