Part D Dossier documents matrix – Key Mandatory ● ○ Optional – there may be regulatory requirements that determine if it is required. Refer to part B of this document for module 1 requirements. <blank> Not required Category 1 / Category 2 Submissions Category 3 Submission TGA's Submission Fee type A - NCE B - New C - D - F - Major Variation E - J - PI G - Minor Variation, new Register Entry H - Minor is… Combination EOI Generic Additional Change variation, Tradename requiring not evaluation resulting Applying for a … New New salt Biosimilar New New New Route of Change Change Change of New Change of in a new chemical or ester of medicine Strength Dosage administration in Patient of Formulation Container tradename Register entity existing Form Group Dosage Type Entry active (not ingredient decrease) Module 1 Electronic Module ● ● ● ● ● lodgement cover 1.0.0 page Letter of Module Application ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● 1.0.1 (describing change) Module Responses to 1.0.2 questions
Part D – Dossier documents matrix Key ● Mandatory ○ Optional – there may be regulatory requirements that determine if it is required. Refer to part B of this document for module 1 requirements. <blank> Not required Category 1 / Category 2 Submissions Category 3 Submission TGA's Submission Fee type is… A - NCE B - New Combination C - EOI D - Generic F - Major Variation E - Additional Tradename J - PI Change requiring evaluation G - Minor Variation, new Register Entry H - Minor variation, not resulting in a new Register Entry Applying for a … New chemical entity New salt or ester of existing active ingredient Biosimilar medicine New Strength New Dosage Form New Route of administration Change in Patient Group (not decrease) Change of Dosage Change of Formulation New Container Type Change of tradename Module 1 Module 1.0.0 Electronic lodgement cover page ● ● ● ● ● Module 1.0.1 Letter of Application (describing change) ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Module 1.0.2 Responses to questions
pm-ctd-module1-1101-a.docx