Configure EDI for EMA and PMDA

The following table lists and describes the fields on the EDI tab to be set up for the EMA and PMDA profiles:
Agency Identifier EVCTM or EVPM PMDA
Secondary Agency/Department Identifier Not applicable Not applicable
File type XML XML
Company identifier As applicable As applicable
Message Profile ICH-ICSR V3.0 MESSAGE TEMPLATE - EMA ICH-ICSR V3.0 MESSAGE TEMPLATE - PMDA
ACK Profile ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - EMA ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - PMDA
Suppress ACK transmission Marked Unchecked (Default)
Transmit ICSR Attachments Marked Marked
Attachment Classification As applicable As applicable
Allowed attachment file size (in MB) 15 MB 15 MB
Allowed report size (in MB) 100 MB

AS1: 10 MB

AS2: 50 MB

Incoming folder Refer to the note below Refer to the note below
Outgoing folder Refer to the note below Refer to the note below
ICSR Attachment Outgoing Folder Not required Not required
File Name As required, for example: EVPM_########.xml As required, for example:PMDA_########.xml
Method E2B EDI gateway E2B EDI gateway

Note:

If the common profile switch Base directory path for gateway folders is specified, then the Base directory path can be \\10.100.80.100\Gatewaysharedfolder\. The In/Out folders then need to be specified with sub folder path such as EVPM\IN, EVPM\OUT. Interchange services creates folders in the format <Base folder path>\<Abbreviated Enterprise name >\<Sub folder path>. If the folder name created by the Interchange services is not required when inserting the Abbreviated name of the Enterprise between the base directory path and the sub folder path, then the Interchange service to exclude Enterprise abbreviated name for folder creation parameter in the EDI tab of Reporting Destination code list needs to be marked.

Note:

If the Common profile Switch Base directory path for gateway folders is not specified, then In/Out folders need to be specified with an absolute path such as \\10.100.80.100\Gatewaysharedfolder\EVPM\IN. Interchange services creates folders using the folder structure provided in the Sub folder path.