Extension Types and Usage

You should provide attribute values in each assembly for the following elements that result in the creation of additional attributes for their corresponding XML elements.

• 1 Administrative Information and Prescribing Information in US (DTD 2.01), CH, JP, ZA, AU, WHO, or TH template
• 1 Administrative and Product Information in CA template
• 1 Administrative Information folder in US (DTD 3.3) template
• EMA Envelope Information in EU template (The path to this is: 1 Administrative Information and Prescribing Information\Envelope Information folder\EU Envelope Information leaf\EMA Envelope Information.) EMA is used as an example. You can name any value you choose from the country list.
• GCC Envelope Information in GCC templates 
• Galenic Form in CH template
• Elements under 1.1 Forms in US (DTD 3.3) template
• 1.15 Promotional Material Audience Type in US (DTD 3.3) template
• 1.15.2 Materials in US (DTD 3.3) template
• 1.15.2.1 Material in US (DTD 3.3) template
• 2.3.S  Drug Substance (substance and manufacturer)
• 2.3.P  Drug Product (product name, manufacturer, dosage form)
• 2.7.3  Summary of Clinical Efficacy (indication)
• 3.2.S  Drug Substance (substance and manufacturer)
• 3.2.P  Drug Product (product name, manufacturer, dosage form)
• 3.2.P.4  Excipients (excipient name)
• 3.2.A.1  Facilities and Equipment (manufacturer, substance, dosage form, and/or product name)
• 3.2.A.2  Adventitious Agents (manufacturer, substance, dosage form, and/or product name)
• 5.3.5  Reports of Efficacy and Safety Studies (indication)
• Study Report Folders (when creating STFs: Full Report Title, Report Number, Category information as applicable)

There are more extension types available, but the extension types listed here are needed for the XML headings that have additional attributes. The others are used to differentiate unnumbered sections and create other components in the XML that do not require additional information.