Switzerland
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| CH Module 1 folder (v1.2 , v.1.3, and v1.4) |
— Application Number — Submission Description — Invented Name — DMF Number — PMF Number — INN — Applicant — DMF Holder — PMF Holder — Agency — Submission Type — Paragraph 13 TPA — Sequence Number — Related Sequence |
1 Administrative Information and Prescribing Information folder in CH Module 1 assembly template |
When applied to a folder in an Assembly that is using the ch-1-2, ch-1-3, or ch-1-4 XML Definition file, triggers the creation of the chregional.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 <ch-envelope> element of the ch-regional.xml file. Multiple comma-separated values can be provided for: — Application Number — Invented Name — INN — Related Sequence The child folders of this folder complete the remainder of the chregional.xml file. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| CH Module 1 folder (v1.5) |
— Application Number — Submission Description — Invented Name — DMF Number — PMF Number — INN — Applicant — DMF Holder — PMF Holder — Agency — Submission Type — Article 13 TPA — Sequence Number — Related Sequence |
1 Administrative Information and Prescribing Information folder in CH Module 1 assembly template |
When applied to a folder in an Assembly that is using the ch-1-5 XML Definition file, triggers the creation of the ch-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 <ch-envelope> element of the ch-regional.xml file. Multiple comma-separated values can be provided for: — Application Number — Invented Name — INN — Related Sequence The child folders of this folder complete the remainder of the chregional.xml file. |
| CH Galenic Form folder |
— Galenic Form Name — SwissMedic Number — Galenic Language Name — Galenic Language Text |
Galenic Form folder in CH Module 1 assembly template | Creates the <galenic-form> element within the <envelope country="ch"> element in the chregional.xml. If there are leafs submitted under the subfolders of the folder with this extension applied, creates the <m1-galenic-form> element in the ch-regional.xml file. The values of the attributes populated on this folder are used to complete the attributes of <galenic-form> and <m1-galenic form> elements. |
|
CH Common Form folder |
No additional attributes | Common folder in CH Module 1 assembly template | Creates the <m1-galenic-form> element in the ch-regional.xml file with the name="common" attribute populated. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
|
CH Swiss Responses folder |
No additional attributes |
Responses to Swissmedic LoQ folder in CH Module 1 assembly template |
Creates the appropriate <m1-swissresponses> element in the chregional.xml file. |
| CH Additional Data folder | No additional attributes |
Additional Information in CH Module 1 assembly template |
Creates the appropriate <m1additional-data> element in the ch-regional.xml file. |