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Acknowledgment of reports

Electronic data interchange for ICSR submission using the E2B R2 format
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Following submission, you will receive a message delivery notification (MDN) from our system confirming receipt of the message. An acknowledgment message relating to the success or failure of the transmission at both the ICSR batch and ICSR message level will be sent following processing of the message. Validation of ICSRs to the ICSR business rules occurs in the following stages, which are illustrated in figure 1:

  1. Batch transmission - formatting compliance of a batch of XML files
  2. Message header validation - compliance with the R2 batch rules
  3. ICSR validations - compliance of individual cases with the business rules.
  4. Acknowledgement of successful transmission.

Figure 2: ICSRs (medicines) transmitted via EDI using the E2B (E2) standard
flow chart - text version available below

Text version of Figure 2

This text representation of Figure 2 is provided as a list with numbered steps.

Prior to commencement there will be an on-boarding process for external users - includes gateway configuration for authentication

  1. [Sponsor's System] ICSRs for AR from medicines sent using E2B R2 standard.
  2. [TGA System] Well formed XML?
    1. No - [Sponsor's System] Schema validation fault error. End flowchart.
    2. Yes - Go to Step 3.
  3. [TGA System] Validates against R2 batch rules. Valid?
    1. No - [TGA System] Generates acknowledgement response for failed batch - [Sponsor's System] Receives acknowledgement response (failure) (Transn. Ack Code = 03). End flowchart.
    2. Yes - Go to Step 4.
  4. [TGA System] Validates against R2 business rules. Valid?
    1. No - [TGA System] Generates acknowledgement response for failed ICSRs - [Sponsor's System] Receives acknowledgement response (failure) (Transn. Ack Code = 02). End flowchart.
    2. Yes - Go to Step 5.
  5. [TGA System] Transforms to R3 message.
  6. [TGA System] Report created in TGA systems.
  7. [TGA System] Generates acknowledgement response for successful ICSRs.
  8. [Sponsor's System] Receives acknowledgement response (sucess) (Transn. Ack Code = 01).
  9. End flowchart.

At each stage, acknowledgment messages may be generated relating the transmission of the report. If a batch message does not have a well-formed XML structure, a general error message, "SchemaValidationFault" will be returned. The XML should be reviewed to ensure it follows the formatting specified in the ICH ICSR DTD.

ICSR acknowledgement message

Following transmission of an ICSR report, you will receive an acknowledgement message. This message advises on whether the batch of ICSRs was successfully transmitted.

The codes are:

  • 01 all ICSR reports in the batch have successfully loaded
  • 02 not all ICSR reports in the batch have successfully loaded - refer to the ICSR business rules.
  • 03 batch validation error, no ICSR reports in the batch have successfully loaded - refer to the ICSR business rules.

This message also advises whether the individual ICSR was successfully processed. The codes are:

When a report is not loaded the acknowledgment message will include information on the first encountered error in B.1.9 errormessagecomment. The default error message is as follows:

<<DTD Descriptor>>:'Invalid data supplied. Please refer to the TGA EDI ICSR R2 Implementation Guidelines'.

Certain errors will result in specific error messages which are detailed below in the TGA specific validation rules for the relevant data elements.

All cases that are not loaded should then be corrected in the identified field to align with the ICH ICSR DTD and the ICSR business rules, which includes guidance for correcting issues identified in acknowledgement messages. The corrected case/s should then be re-transmitted to the E2B R2 EDI service.

Note: Batches sent to the TGA must contain only one ICSR. Where the ICSR did not load, the acknowledgment message will only provide information on the first error encountered in sequential order of the DTD element number as defined in the R2 standard. Therefore, additional errors may be identified in subsequent validations of the same case.

 

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