EAM 2 / GUI 10- Guidelines for the completion of the Annual Summary Template
EAM 2 / GUI 10- Guidelines for the completion of the Annual Summary Template
This document provides guidance on how to capture the safety data related to the reported occurrences in the AST. Each year States are required to send the following AST reports: A report containing the consolidated data of the previous year, including updated data for the first six months of that previous year by the end of March of each year; A report containing initial data covering the first six months (January-June inclusive) of the respective year by the end of September and an updated report for the full previous year (if applicable); A report containing updates of any previously submitted reports; Updates of AST reports older than 2 years not captured in previous submissions or other updated AST reports are welcomed at any time.






