Section 9 Presentation of the name of the TGO 91 & 92: 9(2)-(3) Industry have raised Maintained. medicine: continuous uninterrupted concerns that this section A document was circulated to industry peak bodies in manner and not be broken up by as written would impact on March 2016 for comment. The document outlined additional information or background trademarks and branding. TGA’s rationale for this requirement and general text It has been requested that principles for interpreting this requirement. This this be changed to ‘best information will be included in the labelling guidance. practice’. Option for use of active moiety only TGO 92: 9(7) Concerns with lack of Maintained. (not full approved name) on the main harmonisation with NZ. label Concern with potential issue of differing requirements between products (e.g. active moiety vs full name on main label) as potentially being confusing to a consumer.
Section 9 Presentation of the name of the medicine: continuous uninterrupted manner and not be broken up by additional information or background text TGO 91 & 92: 9(2)-(3) Industry have raised concerns that this section as written would impact on trademarks and branding. It has been requested that this be changed to ‘best practice’. Maintained. A document was circulated to industry peak bodies in March 2016 for comment. The document outlined TGA’s rationale for this requirement and general principles for interpreting this requirement. This information will be included in the labelling guidance. Option for use of active moiety only (not full approved name) on the main label TGO 92: 9(7) Concerns with lack of harmonisation with NZ. Concern with potential issue of differing requirements between products (e.g. active moiety vs full name on main label) as potentially being confusing to a consumer. Maintained.