Australia
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| AU Module 1 folder (v3.2) |
— e-Identifier — eBS Client ID — Approved Name(s) — Trade Name(s) — ARTG Number(s) — Submission or Application Number(s) — Sequence Number — Related Sequence Number — Regulatory Activity Lead — Submission Mode — Sequence Type / Sequence Description — Contact Email |
1 Administrative Information and Prescribing Information folder of the AU eCTD template |
When applied to a folder in an Assembly that is using the au-3-2 Definition file, triggers the creation of the au-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <au-envelope> element of the au-regional.xml file. Multiple, comma-separated values can be provided for: — Approved Name — Trade Name — ARTG Number — Submission or Application Number — Contact Email The child folders of this folder complete the remainder of the au-regional.xml file. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| AU Module 1 folder (v3.1) |
— e-Identifier — eBS Client ID — Approved Name (s) — Trade Name(s) — ARTG Number (s) — Submission or Application Numbers (s) — Sequence Number — Related Sequence Number — Regulatory Activity Lead — Submission Mode — Sequence Type — Sequence Description — Contact Email |
1 Administrative Information and Prescribing Information folder of the AU eCTD template |
When applied to a folder in an Assembly that is using the au-3-1 Definition file, triggers the creation of the au-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <au-envelope> element of the au-regional.xml file. Multiple, comma-separated values can be provided for: — Approved Name — Trade Name — ARTG Number — Submission or Application Number — Contact Email The child folders of this folder complete the remainder of the au-regional.xml file. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| AU Module 1 folder (v0.90 and v3.0) |
— eSubmission Identifier — Applicant — Australian Approved Name(s) — Product Name — ARTG Number — Sequence Description — Sequence Number — Related Sequence Number — Regulatory Activity Lead — Sequence Type |
1 Administrative Information and Prescribing Information folder of the AU eCTD template |
When applied to a folder in an Assembly that is using the au-0-90 or au-3-0 Definition file, triggers the creation of the au-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <auenvelope> element of the auregional.xml file. Multiple, comma separated values can be provided for: — Australian Approved Name(s) — Product Name — ARTG Number The child folders of this folder complete the remainder of the au-regional.xml file. |