necessarily affect complexity and/or scope could also result in the submission being considered to be not effective. Review any issues identified in the TGA’s pre-submission planning letter for the submission. For each issue in the TGA’s pre-submission planning letter, confirm that it has been addressed and how it was addressed. Prepare a declaration that: Either states that the submission is consistent with the pre-submission planning form lodged OR lists any inconsistencies with appropriate justifications for their inclusion in the submission, and Lists any issues identified as requiring sponsor action in the TGA pre-submission planning letter and identifies how these issues have been addressed. Points to note The TGA will check the submission for consistency with the pre-submission planning form. Extensive differences between the pre-submission planning form and the submission may result in the TGA considering the submission to be not effective i.e. will not be accepted for evaluation. Before lodging a submission with apparent inconsistencies with the corresponding planning form that cannot be readily justified, sponsors are strongly advised to discuss the matter with the Office of Medicines Authorisation to determine the best path. Administrative changes (e.g. correction of spelling errors, repaginations) are not considered to be significant differences. Module 1.9 Individual patient data Overview This section of the module 1 holds information regarding the applicant’s ability to provide individual patient data to support the studies provided in the dossier should the need arise. The following information describes each document in the section, outlines when each document needs to be provided and any other requirements relating to the documents Contents
necessarily affect complexity and/or scope could also result in the submission being considered to be not effective. Review any issues identified in the TGA’s pre-submission planning letter for the submission. For each issue in the TGA’s pre-submission planning letter, confirm that it has been addressed and how it was addressed. Prepare a declaration that: Either states that the submission is consistent with the pre-submission planning form lodged OR lists any inconsistencies with appropriate justifications for their inclusion in the submission, and Lists any issues identified as requiring sponsor action in the TGA pre-submission planning letter and identifies how these issues have been addressed. Points to note The TGA will check the submission for consistency with the pre-submission planning form. Extensive differences between the pre-submission planning form and the submission may result in the TGA considering the submission to be not effective i.e. will not be accepted for evaluation. Before lodging a submission with apparent inconsistencies with the corresponding planning form that cannot be readily justified, sponsors are strongly advised to discuss the matter with the Office of Medicines Authorisation to determine the best path. Administrative changes (e.g. correction of spelling errors, repaginations) are not considered to be significant differences. Module 1.9 Individual patient data Overview This section of the module 1 holds information regarding the applicant’s ability to provide individual patient data to support the studies provided in the dossier should the need arise. The following information describes each document in the section, outlines when each document needs to be provided and any other requirements relating to the documents Contents
pm-ctd-module1-1101-a.docx