South Africa
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| ZA Module 1 folder v3.1 |
— Application Type — Application ID — Application Number — Proprietary Name — Dosage Form — INN — APIMF Number — PMF Number — VAMF Number — SMF Number — Submission (Submission Type/Evaluation Pathway/ Submission Lead/ Submission Number — Sequence Type — Sequence Description — Sequence Date — Sequence Number — Related Sequence — Multiple Applications (Application Number/ Proprietary Name) — Contact |
1 Administrative Information and Prescribing Information folder in ZA Module 1 assembly template |
When applied to a folder in an Assembly that is using the za-3-1 Definition file creates the zaregional.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 <za-envelope> element of the za-regional.xml file. Multiple comma-separated values can be provided for: — SMF Number — Application Number — Dosage Form — INN — APIMF Number — VAMF Number — Proprietary Name — PMF Number — Related Sequence |
| Note: Multiple paired values can be provided for the Multiple Applications attribute. While Multiple Applications is not required (both Application Number and Proprietary Name can be empty) it is required to have both values either populated or empty. If only one field is populated, a validation message is displayed. | |||
| The child folders of this folder complete the remainder of the zaregional.xml file. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| ZA Module 1 folder v2.1 |
— Application Number — Applicant — Submission Type/Proof of Efficacy — Proprietary Name — Dosage Form — INN — eCTD Sequence — Related Sequence — Duplicated Applications (Proprietary Names/ Application Numbers) |
1 Administrative Information and Prescribing Information folder in ZA Module 1 assembly template |
When applied to a folder in an Assembly that is using the za-2-1 Definition file, triggers the creation of the za-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 <za-envelope> element of the za-regional.xml file. Multiple comma-separated values can be provided for: — Application Number — Proprietary Name — Dosage Form — INN — Related Sequence The child folders of this folder complete the remainder of the za-regional.xml file. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| ZA Module 1 folder v1.0 |
— Application Number — Applicant — Submission Type — Proof of Efficacy — Proprietary Name — Dosage Form — INN — eCTD Sequence — Related Sequence — Duplicated Applications (Proprietary Names/Dates of Application |
1 Administrative Information and Prescribing Information folder in ZA Module 1 assembly template |
When applied to folder in an Assembly that is using the za-1-0 Definition file, triggers the creation of the zaregional.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 <za-envelope> element of the za-regional.xml file. Multiple comma-separated values can be provided for: — Application Number — Proprietary Name — Dosage Form — INN — Related Sequence The child folders of this folder complete the remainder of the za-regional.xml file. |