6 Correct heading used = 6 PHARMACEUTICAL Yes No PARTICULARS 6.1 Correct heading used = 6.1 LIST OF EXCIPIENTS Yes No If excipient list was retained in section 2, has the appropriate Yes No N/A cross-reference been added? [not appropriate for new PIs]* to Section 2 - Qualitative and quantitative composition’ ‘Refer 6.2 Correct heading used = 6.2 INCOMPATIBILITIES Yes No If there is no statement in approved PI, has the optional Yes No N/A standard text been added? were either not assessed or not identified as ‘Incompatibilities part of the registration of this medicine’, or a relevant to section 4.5. 6.3 Correct heading used = 6.3 LIFE Yes No If the shelf-life is not included, has the optional standard text Yes No N/A been used? Australia, information on the shelf life can be found on the ‘In public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.’ Yes No 6.4 Correct heading used = 6.4 SPECIAL PRECAUTIONS FOR STORAGE 6.5 Correct heading used = 6.5 NATURE AND CONTENTS OF Yes No CONTAINER 6.6 Correct heading used = 6.6 SPECIAL PRECAUTIONS FOR Yes No DISPOSAL If there is no statement in approved PI, has one of the optional Yes No N/A standard text statements been added? Australia, any unused medicine or waste material should be ‘In disposed of by taking to your local pharmacy’ or Australia, ‘In any unused medicine or waste material should be disposed of in accordance with local requirements’ 6.7 Correct heading used = 6.7PHYSICOCHEMICAL Yes No PROPERTIES Have the mandatory subheadings been included? Chemical structure Yes No CAS number Yes No 7 Correct heading used = 7 MEDICINE SCHEDULE (POISONS Yes No STANDARD) 8 Correct heading used = 8 SPONSOR Yes No
6 Correct heading used = 6 PHARMACEUTICAL PARTICULARS Yes No 6.1 Correct heading used = 6.1 LIST OF EXCIPIENTS Yes No If excipient list was retained in section 2, has the appropriate cross-reference been added? [not appropriate for new PIs]* ‘Refer to Section 2 - Qualitative and quantitative composition’ Yes No N/A 6.2 Correct heading used = 6.2 INCOMPATIBILITIES Yes No If there is no statement in approved PI, has the optional standard text been added? ‘Incompatibilities were either not assessed or not identified as part of the registration of this medicine’, or a relevant to section 4.5. Yes No N/A 6.3 Correct heading used = 6.3 LIFE Yes No If the shelf-life is not included, has the optional standard text been used? ‘In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.’ Yes No N/A 6.4 Correct heading used = 6.4 SPECIAL PRECAUTIONS FOR STORAGE Yes No 6.5 Correct heading used = 6.5 NATURE AND CONTENTS OF CONTAINER Yes No 6.6 Correct heading used = 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Yes No If there is no statement in approved PI, has one of the optional standard text statements been added? ‘In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy’ or ‘In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements’ Yes No N/A 6.7 Correct heading used = 6.7PHYSICOCHEMICAL PROPERTIES Yes No Have the mandatory subheadings been included? Chemical structure CAS number Yes No Yes No 7 Correct heading used = 7 MEDICINE SCHEDULE (POISONS STANDARD) Yes No 8 Correct heading used = 8 SPONSOR Yes No
new-product-information-format-checklist-for-sponsors.docx