PSUR CHECKLIST & OPTIONAL TEMPLATE This template is designed to be used as a guide to compiling a PSUR, and can be edited to suit local formatting; the content should remain the same. Company name: Product name(s): National/CAP name in that country – MRP/DCP name in RMS (other names should be included in the table of MA – numbers. Procedure number: (if applicable) EBD/Start date of PSUR cycle: National date of authorisation – MRP/DCP Day 90 – Period covered by this PSUR: Chronological order of PSUR: e.g. First six-monthly PSUR Date of initial placing on market: Author: Reviewer: This is not necessary if you have an internal system for QC of the document MA number(s) : Country MA numbers
PSUR CHECKLIST & OPTIONAL TEMPLATE This template is designed to be used as a guide to compiling a PSUR, and can be edited to suit local formatting; the content should remain the same. Company name: Product name(s): National/CAP – name in that country MRP/DCP – name in RMS (other names should be included in the table of MA numbers. Procedure number: (if applicable) EBD/Start date of PSUR cycle: National – date of authorisation MRP/DCP – Day 90 Period covered by this PSUR: Chronological order of PSUR: e.g. First six-monthly PSUR Date of initial placing on market: Author: Reviewer: This is not necessary if you have an internal system for QC of the document MA number(s) : Country MA numbers