When working with South African regulatory submissions, Submissions Publishing allows you to generate ZA v3.1 (DTD v3.1) compliant XMLs for submission to the South African Health Products Regulatory Authority (SAHPRA). Vault can validate these submissions in accordance with the ZA SAHPRA 3.1 Validation Criteria Version.
Note: This feature is only available on RIM Submissions Publishing Vaults.
About Node Extensions
The South African eCTD specification supports node extensions or STFs in your submission.
Copying a Content Plan for ZA Submissions
When copying a content plan from another submission, Vault removes all country-specific data with the exception of the STF Content Plan Item record to support other regions that accept STFs. In order for the publishing process to work correctly for copied submissions, you must set the Continuous Publishing and Continuous Validation fields to Yes on all Content Plan Items.
Viewing & Managing Submission Administrative Information
Vault supports viewing Submission Administrative Information for ZA 1.0, 2.1, and 3.1 DTDs. You can also manage Submission Administrative Information for ZA 2.1 and 3.1 DTDs.
In addition to the functionality described in Managing Submission Administrative Information, Vault groups some fields on South African submissions in the Submission Administrative Information viewer. Fields within the group appear indented. From the first field within a group, you can select Add Value from the field’s Actions menu to add a new field group. If you select Delete Value, Vault deletes the entire group.
Managing Submissions Across Versions 2.1 & 3.1
South Africa changed the structure of their Module 1 between versions 2.1 and 3.1.
If it is absolutely necessary to replace v2.1 content that is in the previous structure, SAHPRA recommends that it is first Deleted (lifecycle operation), and then submitted as New (lifecycle operation) in the new structure.
With assistance from a Veeva representative, you can download a VPK with the latest Content Plan Template for v3.1 from the Support Portal.