The informed authority (AER_INFM_AUTH) record is created or updated, after receiving the acknowledgement for the exported cases, and when the cases are exported to the authorities and not to the other company units.
If multiple acknowledgments are received for an exported case, the informed authority record is created or updated after importing each acknowledgment.
For an exported case, the informed authority record is created or updated even if the <reportacknowledgement> block is missing in the received acknowledgments.
Note: When the acknowledgments are received for the cases exported to FDA, the periodic informed authority record is not updated if the Do Not Update Periodic IA Record For FDA parameter is selected in the ESM Admin > Setup > General tab.
The application generates H.5.r Case Summary and Reporter’s Comments in Native Language in Russian Language when native language is ‘Russian’ and one of the following condition is satisfied:
1. Distribution Contact Country = "Russia"
2. Distribution Contact Authority = "Roszdravnadzor (Russia)"
3. Recipient Company Unit Country = "Russia"
4. Recipient Company Unit Authority = "Roszdravnadzor (Russia)"
The tag H.5.r is exported only when the data is present in the Russian Language for Russian Export and Inform Authority data also will be considered for the same logic to populate H.5.r.
The informed authority records are updated in the following scenarios:
When the acknowledgement received date is selected for the receiver unit, the informed authority record(s) is created or updated, after ESM imports the acknowledgement for the export case.
When the MDN date is selected for the receiver unit, the authority record(s) is created when ESM receives the MDN.
While updating of informed authority record, if the AER case is kept open then the informed authority record is not updated and you need to update it manually.
When the informed authority record does not exist, a new record is created with the following details:
Column Name |
Value |
REPORTING_STATUS |
INFORMED |
DATE_INFORMED |
Date on which the case is electronically sent to the authority. That is, E2B_MESSAGE_QUEUE.TRANSMISSION_DATE. |
RECORD_OWNER_UNIT |
Sender of the case. That is, E2B_MESSAGE_QUEUE.SENDER_ORGANIZATION. |
AUTHORITY_RESPONDED |
Yes / No (whether acknowledgment is received or not). |
AUTHORITY_RESP_DATE |
Date on which the acknowledgment is received. (taken from the Oracle system date). |
INFORMING_UNIT |
Sender Unit of the case (The sender unit is same as the RECORD_OWNER_UNIT). |
SEQ_INFM_AUTH |
Sequence |
STATUS_AUTH_FLAG |
0 |
VERSION_NO_AER |
AER version number (AER.VERSION_NO) |
AUTHORITY |
UNIT_CODE. That is, E2B_MESSAGE_QUEUE.RECEIVER_ORGANIZATION. |
INITIAL_AER_ID |
AER.INITIAL_AER_ID |
LOCAL_VERSION_NO |
0 |
REPORT_FOLLOW_UP_NO |
Follow-up number for the authority |
REPORT_FORMAT |
E2B/R2 (codelist value) |
REPORT_MEDIUM |
Electronic Transfer Structured Data (codelist value) |
TYPE_OF_REPORT |
Alert Report/15 day alert report. |
IDENTIFICATION_NO |
The identification number given to the AER by an authority. The number is displayed only when the E2B_LANGUAGE is Japanese. The value is considered from the E2B_REPORT_ACK. LOCAL_REPORT_NUMBER field. |
When the informed authority record exists, update the existing record with the following details:
Column Name |
Value |
REPORTING_STATUS |
INFORMED |
DATE_INFORMED |
Date on which the case is electronically sent to the authority. That is, E2B_MESSAGE_QUEUE.TRANSMISSION_DATE. |
AUTHORITY_RESPONDED |
Yes/No (whether acknowledgment is received or not). |
AUTHORITY_RESP_DATE |
Date on which the acknowledgment is received (taken from the Oracle system date). |
IDENTIFICATION_NO |
The identification number given to the AER by an authority. The number is displayed only when the E2B_LANGUAGE is Japanese. The value is considered from the E2B_REPORT_ACK. LOCAL_REPORT_NUMBER. |