Vault can create PDF viewable renditions for Structured Product Labeling (SPL) submissions uploaded as ZIP files, allowing you to easily preview your submission. The rendition is a single-page PDF and mirrors how the SPL appears in a browser.
Vault can also render PDFs for ZIP files containing XML with valid HTML transformations (XSL/XSLT).
Note: This feature is only available on RIM Vaults that include the Submissions application. See Importing Submissions for information about XML renditions in Submissions Archive Vaults.
SPL File Criteria
When you upload a ZIP of an SPL rendition as a document source file, Vault can render it if it meets the following criteria:
- The ZIP contains only one (1) XML file and image files.
- The XML header includes the correct FDA stylesheet/schema information.
- Files are in the root of the ZIP folder.
If the ZIP doesn’t meet these criteria, Vault treats it like any other ZIP file and does not create a viewable rendition.
FDA Stylesheet/Schema
<?xml-stylesheet href="http://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?><br />
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 http://www.accessdata.fda.gov/spl/schema/spl.xsd">
XML File Criteria
When you upload a ZIP file with XML, Vault can render it if it meets the following criteria:
- The primary XML file must be clearly identified in the ZIP in one of the following ways:
- The ZIP structure contains only one (1) XML file, which can be in any directory and which Vault uses as the primary source for the rendition.
- The ZIP structure contains only one (1) XML file at the root directory, which Vault uses as the primary source for the rendition. Other supporting XML can be in sub-directories.
- The ZIP contains at least one (1) stylesheet (XSL/XSLT) file that is either in the root directory or referenced within the XML file. Vault can only render styles if the stylesheet uses XSL V1.0.
- The XML does not include external references to stylesheets or DTD/XSD files.
- The XML must be valid according to the DTD/XSD criteria.
If the ZIP doesn’t meet these criteria, Vault treats it like any other ZIP file and does not create a viewable rendition.