European Union


Extension Type	Associated Attributes	Applied to Assembly Element	Result
EU Module 1 folder	No additional attributes	1 Administrative Information and Prescribing Information folder in EU Module 1 assembly template	When applied to an Assembly folder that is using the eu-2-0 XML Definition file creates the eu-regional.xml file during publishing. The child folders of this folder complete the content included in the eu-regional.xml file.


Extension Type	Associated Attributes	Applied to Assembly Element	Result
EU Module 1 Envelope Information folder (v3.0 and v3.0.1)	— Country — UUID — Submission Type — Submission Mode — High-Level/ Worksharing Submission Number — Application Tracking Number — Submission Unit Type — Applicant — Agency Name — Procedure Type — Invented Name — INN — Sequence — Related Sequence — Submission Description	Depending on the procedure type/ template selected, there will be appropriate CC Envelope Information folder(s) that is a child of the EU Envelope Information leaf in EU Module 1 assembly template. A folder for each country applicable in the sequence should be included to provide the appropriate envelope information.	Attribute values provided for each folder with this type complete the envelope information for the country specified within the euregional.xml file. You must create a separate folder for each country for which envelope information is provided. These folders should reside beneath the EU Envelope Information Leaf to ensure proper behavior during life cycle updates. Multiple commaseparated values can be provided for: — Application Tracking number — Invented Name — INN — Related Sequence


Extension Type	Associated Attributes	Applied to Assembly Element	Result
EU Module 1 Envelope Information folder (v2.0)	— Country — Submission Type — Submission Mode — High-Level/ Worksharing Submission Number — Application Tracking Number — Applicant — Agency Name — Procedure Type — Invented Name — INN — Sequence — Related Sequence — Submission Description	Depending on the procedure type/ template selected, there will be appropriate CC Envelope Information folder(s) that is a child of the EU Envelope Information leaf in EU Module 1 assembly template. A folder for each country applicable in the sequence should be included to provide the appropriate envelope information.	Attribute values provided for each folder with this type complete the envelope information for the country specified within the euregional.xml file. You must create a separate folder for each country for which envelope information is provided. These folders should reside beneath the EU Envelope Information Leaf to ensure proper behavior during life cycle updates. Multiple commaseparated values can be provided for: — Application Tracking number — Invented Name — INN — Related Sequence


Extension Type	Associated Attributes	Applied to Assembly Element	Result
EU Module 1 Country-specific Information folder	— Country — Language	— In EU Module 1 Assembly template, applied to the following folders: — 1.0 Cover Letter — 1.2 Application Forms — 1.3.2 Mock-up — 1.3.3 Specimen — 1.3.4 Readability Testing — 1.3.5 SPCs already approved in Member States	Creates the appropriate <m1-0cover>, <m1-2-form>, <m1-3-2mockup>, <m1-3-4-readability>, and <m1-3-5-approved> elements in eu-regional.xml with country values for the <specific> child element. Also includes the appropriate country values in the output directory structure. Each folder with this type can be duplicated for different countries and/or languages for which information is being provided.
EU Module 1 Labeling Information folder	— Country — Language — Labeling type	— 1.3.1 SPC, Labeling and Package Leaflet folder in EU Module 1 Assembly template	Creates the appropriate <m1-3-1-spc-label-pl> element with the <pi-doc> child element using attribute values to populate the attributes of the <pi-doc> element. Also includes appropriate country and language information in the output directory structure. Each folder with this type can be duplicated for different countries, languages, and/or labeling types for which information is being provided. The Create eCTD Wizard allows the user to indicate which sections should be included for all countries.
EU Responses folder	— Country — Language	Responses to Questions folder in the EU Module 1 Assembly template	Creates the appropriate <m1responses> element in euregional.xml with country values for the <specific> child element. Also includes appropriate country information values in the output directory structure.
Extension Type	Associated Attributes	Applied to Assembly Element	Result
EU Additional Informa tion folder	— Country — Language	Additional Data folder in the EU Module 1 Assembly template	Creates the appropriate <m1additional> element in euregional.xml with country values for the <specific> child element. Also includes appropriate country information values in the output directory structure.