Configure Regulatory Authorities

Transmitting E2B reports to an Agency/Trading Partner, requires you to create a regulatory authority entry in the Code List. After creating the regulatory authority, you can transmit regulatory reports to it.

To configure a regulatory authority:

1. On the Oracle Argus Safety Console, click Code Lists > Argus.
2. When the system opens the Code List Maintenance screen, select Reporting Destination from the list.
   

   Note:

   If a report has already been generated for a Regulatory Authority, the system disables the Delete button in the Code List dialog box for the particular Regulatory Authority. However, it is still possible to modify these reports there.

   Refer to the Oracle Argus Safety User's Guide for information on using the first three tabs of the Reporting Destination.

3. Click the EDI tab, select the appropriate data for each item, and enter the data in the fields as required.
   

Note:

When the Message Profile field is set to PMDA Device:

• The following parameters are automatically set in the Reporting Destination codelist:
  • XML Version is set to 1 and disabled.
  • Encoding is set to UTF-8 and disabled.
  • The Attachments parameter under the Report Transmissions options in the Agency Information tab is defaulted to Single and disabled.
• The following parameters are disabled in the Reporting Destination codelist:
  • ICSR Attachment Outgoing Folder
  • Identification Code(Agency Information and Local Company Contact)
  • Code Qualifier
  • SGML Declaration File
  • Maximum # of reports to include in the msg
  • File Name
  • Method
  • EDI Header Required
  • URL for Message Schema
  • URL for Ack Schema
  • Primary Receive Agency
  • Auto Accept ICSR's
  • Submission date for ICSR's
  • Imported Case are assigned to
  • Initial Workflow State
  • XML Source Classification
  • Selection Source Classification

For more information, see:

• EDI Tab Fields