Agency Information

Field Descriptions

The Agency Information tab is displayed by default, on selecting Reporting Destination.

The fields under the Agency Information tab are described in the following table:

Field or Control Name	Description
Address 1	Enables you to enter the address of the regulatory contact in line 1.
Address 2	Enables you to enter the address of the regulatory contact in line 2.
Agency Name	Displays the name of the agency. This is a required field.
Agency Type	Enables you to select the agency type.
Allow WHO Drug / J Drug reporting	Enables you to schedule a report for either WHO Drug or J Drug reporting.
Attachments	Enables you to select single or multiple attachments. The default value is Single.
City	Enables you to enter the city of the regulatory contact.
Contact Type	Manufacturer - Enables you to select manufacturer as the type of contact Importer - Enables you to select importer as the type of contact Distributor - Enables you to select distributor as the type of contact Authorized Representative - Enables you to select the Authorized Representative as a type of contact.
Country	Enables you to enter the country of the regulatory contact.
Country Code	Enables you to enter the country code of the regulatory contact.
Department	Enables you to enter the name of the department.
Email Address	Enables you to enter the email address of the agency.
Email Text Body	Select - Enables you to select a .txt or .rtf file to be uploaded. Note: The file should be in .txt, or .rtf format. After the uploaded file is saved, the Edit button displays a clip button, denoting an attachment. Edit - Enables you to open the uploaded file / text in a word document from the server and edit the text inside it. If no file was uploaded earlier, a blank document is opened. Note: You can save the edited document on the local machine and click Select to save the file.
Ext	Enables you to enter the extension number of the regulatory contact.
FAX	Enables you to enter the FAX Number.
FAX Cover	Enables you to enter the FAX Cover.
First Name	Enables you to enter the first name of the regulatory contact.
Last	Enables you to enter the last name of the regulatory contact.
Middle	Enables you to enter the middle name of the regulatory contact.
Offline Recipient	Enables you to configure the regulatory agency as an offline agency.
Phone	Enables you to enter the phone number of the regulatory contact.
Postal Code	Enables you to enter the postal code of the regulatory contact.
Preferred Method	Enables you to select the preferred method of agency information. When you set the message profile to MedWatch, this parameter is set by default to Email.
Registration #	Enables you to enter the registration number.
Report for Investigational Licenses	Enables you to select if the reports are to be investigational always or only for clinical case or no marketed license. This field is set by default to Always.
Report for Marketed Licenses	Enables you to select whether reports are to be marketed as Always or only for the Spontaneous cases or no Investigational. This field is set by default to Always.
Report per Email	Enables you to enter the number of reports to be received in each email.
State/Province	Enables you to enter the state/province of the regulatory contact.
Title	Enables you to enter the title of the regulatory contact.
FAX	Enables you to enter the fax number of the regulatory contact.
Contact Type	Enables you to select the Authorized Representative, Manufacturer, Importer, or Distributor check box.

Use the following procedure to configure agency information.

1. Select the Agency Name (or row) of the reporting destination displayed under Total Number of Rows that needs to be modified. The Modify section displays the information about the selected code list.
2. You may use the Reporting Destination filter to make your search specific to an agency. The filtering criterion is essential as it helps you to search for specific items.
3. Select the appropriate Field as the filtering criteria from the drop-down list.
4. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.
5. Enter the search criteria in Value
6. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new agency information.

   • Click Copy to make an editable copy of an existing agency information.
   • Click Delete to delete the selected agency information.
   • Click Print to print the selected information as a PDF.
7. Enter the name of the agency in the Agency Name field.
8. Select the type of agency in the Agency Type field.
9. Enter the department in the Department field.
10. Enter the email address in the Email field. Multiple e-mail addresses must be separated by a comma (,), and not by a semi-colon (;). If you separate the email addresses by a semi-colon, the transmission service will fail.
11. Select the preferred method from the Preferred Method drop-down list. The options available are Fax or Email.
    When the message profile is set to MedWatch, then the Preferred Method is set by default to Email. When the Preferred Method is set to Email and the Agency's Email Address field is set to blank, then the following warning message is displayed: Agency Email Address cannot be blank. When the message profile is set to FDA MedWatch 3500A, then the following warning message is displayed: Email is the preferred method for this Profile.
12. Enter the registration number in the Registration # field.
13. Enter the Fax Number in the FAX field.
14. Enter the Fax Cover in the FAX Cover field.
15. Select the preferred contact type by clicking the checkboxes available under Contact Type.

    The options available are Manufacturer, Importer, Distributor, and Authorized Representative.

16. Select the Offline Recipient checkbox to configure the regulatory agency as an offline agency.
17. Select the Title of the regulatory contact. The options available are Mr., Miss and Mrs.
18. Enter the first name of the regulatory contact under the First Name field.
19. Enter the middle name of the regulatory contact under the Middle field.
20. Enter the last name of the regulatory contact under the Last field.
21. Enter the postal contact address of the regulatory contact under the Address 1 field.
22. Enter the phone number of the regulatory contact under the Phone field.
23. Enter the extension number of the regulatory contact under the Ext field.
24. Enter the country code to be dialed in calling up the regulatory contact under the Country Code field.
25. Enter the fax number of the regulatory contact under the FAX field.
26. Enter the fax extension number of the regulatory contact under the Ext field.
27. Enter the country code required in faxing up the regulatory contact under the Country Code field.
28. Enter the name of the city where the regulatory contact lives in the City field.
29. Enter the name of the state/province where the regulatory contact lives in the State/Province field.
30. Enter the name of the country where the regulatory contact lives in the Country field.
31. Enter the postal code of the place where the regulatory contact lives in the Postal Code field.
32. Enter the number of reports that need to be sent in every email to the regulatory contact in the Report per Email field.
33. Select whether to send single or multiple attachments with emails through the Attachments drop-down list.
34. Select how the report is to be marketed from the Report to be marketed drop-down list.
35. The options in this list are Always or Spontaneous or No Investigational.
36. Select the Allow WHO Drug / J Drug Reporting checkbox to schedule the report for either WHO Drug or J Drug reporting.
37. Select the type of reports as Investigational always or Only for clinical case or No marketed license from the Report for Investigational drop-down list.
38. Click Save to save the changes made.