& NCE MRF1 ZA CTD Other AMRP & generic or (PARTs) (MODULES) BE Medicine Submission P+A Names Scheduling Clinical Register Scheduling Clinical Clinical Biological BA Covering letter 1.0 X X X X X X X 1.2.2.1 X X Fees (or 1.7.10.1 X X Sample 1.7.10.3 X X CoAs sample 3.2.R.7 X X - X MRF2 1.7 X 1.9 X X X Details of compliance 1.8 X X X X X X with screening outcomes 2.2) 1A 1.2.1 X X X X X X X 1.2.2 X X (refer 3.2.A X 1B 1.1 X X X X payment 1C 1.3 X X X X X and 1.3.1.1, 1.3.2, 1.3.3, 1.5.3 X X X X sample 1D 1.10 X X X X 1.4 X X X X dossier, 2A 2.1 X X Full 2.2 X X X X X 1.5.1 X 2A (without Biostudy) 3.2.R.1.4.2 X 2A 1.11 X (with Biostudy, comparative 3.2.R Complete X X dissolution) 3.2.R X (except 3.2.R.1) 2B - X 2C 2.3 X X (if applicable) 2D 2.4 X X X 2E 2.5 X X X [X]1
MRF1 (PARTs) ZA CTD (MODULES) Submission P+A Names Scheduling & Clinical generic Register Medicine Scheduling NCE Clinical AMRP Clinical & Biological BA BE or Other Covering letter 1.0 Full dossier, sample and payment (refer 2.2) X X X X X X X Fees (or 1.2.2.1 X X Sample 1.7.10.1 X X CoAs sample 1.7.10.3 X X 3.2.R.7 X X MRF2 - X 1.7 X 1.9 X X X Details of compliance with screening outcomes 1.8 X X X X X X 1A 1.2.1 X X X X X X X 1.2.2 X X 3.2.A X 1B 1.1 X X X X 1C 1.3 X X X X X 1.3.1.1, 1.3.2, 1.3.3, 1.5.3 X X X X 1D 1.10 X X X X 1.4 X X X X 2A 2.1 X X 2.2 X X X X X 2A (without Biostudy) 1.5.1 X 3.2.R.1.4.2 X 2A (with Biostudy, comparative dissolution) 1.11 X 3.2.R Complete X X 3.2.R (except 3.2.R.1) X 2B - X 2C (if applicable) 2.3 X X 2D 2.4 X X X 2E 2.5 X X X [X]1
2.24_Guidance_General_Module_1_Jul12_v5_showing_changes.docx