Gulf Cooperation Council
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| GCC Module 1 folder (v1.5) | No additional attributes | GCC Module 1 folder in GCC Module 1 assembly template |
When applied to an Assembly folder that is using the gc-1-5 XML Definition file creates the gc-regional.xml file during publishing. The child folders of this folder complete the content included in the gc-regional.xml file. Multiple comma-separated values can be provided for: — Application Number — ATC — Invented Name — INN — Related Sequence |
| GCC Module 1 folder (v1.2) | No additional attributes | GCC Module 1 folder in GCC Module 1 assembly template | When applied to an Assembly folder that is using the gc-1-2 XML Definition file, triggers the creation of the gcregional.xml file during publishing. The child folders of this folder complete the content included in the gc-regional.xml file. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
|
GCC Module 1 Envelope Information folder (v1.5) |
— Country — Application Number — Applicant — Agency Name — ATC — Submission Type — Submission Unit Type — 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 CC Envelope Information leaf in GCC 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 gcregional.xml file. You must create a separate folder for each country for which envelope information is being provided. These folders should reside beneath the GCC Envelope Information leaf. This is to ensure proper behavior during life cycle updates. Multiple comma-separated values can be provided for: — Application Number — ATC — Invented Name — INN — Related Sequence |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
|
GCC Module 1 Envelope Information folder (v1.2) |
— Country — Application Number — Applicant — Agency Name — ATC — Submission Type — 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 GCC Envelope Information leaf in GCC 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 gcregional.xml file. You must create a separate folder for each country for which envelope information is being provided. These folders should reside beneath the GCC Envelope Information leaf. This is to ensure proper behavior during life cycle updates. Multiple comma-separated values can be provided for: — Application Number — ATC — Invented Name — INN — Related Sequence |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
|
GCC CountrySpecific Information folder |
— Country — Language |
In GCC Module 1 assembly template, applied to the countryspecific subfolders of the following folders: — 1.0 Cover Letter Application Form Summary of Product Characteristics (SPC) — 1.3.2 Labeling — 1.3.3 Patient information leaflet — 1.3.4 Artwork (mock-ups) — 1.3.5 Samples — 1.7.4 Certificate of analysis Excipients — 1.7.5 Alcoholcontent declaration — 1.7.6 Porkcontent declaration — 1.7.7 Certificate of suitability for TSE — 1.7.8 The diluents and coloring agents in product formula — 1.7.9 Patent Information — 1.7.10 Letter of access or acknowledgeme nts to DMF — 1.8.1 Price list — 1.8.2 Other documents related |
Populates the country attribute of the <specific> element within appropriate elements in the gcregional.xml file. Also includes appropriate country information values in the output directory structure. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| GCC Label folder |
— Country — Language — Labeling Type |
In GCC Module 1 assembly template, applied to the language specific subfolders of the following folders: — 1.3.1 Summary of Product Characteristics (SPC) — 1.3.2 Labeling — 1.3.3 Patient information leaflet |
Populates attributes for the <pi-doc> element within appropriate elements in the gc-regional.xml file. Also includes appropriate language values in the output directory structure. |
| GCC Responses folder | Country | 1.9 Responses to Questions folder in GCC Module 1 assembly template | Creates the appropriate <m1-9responses> element in the gcregional.xml file with country values for the <specific> child element. Also includes appropriate country information values in the output directory structure. |
| GCC Additional Data folder | Country | Additional Data folder in GCC Module 1 assembly template | Creates the appropriate <m1additional-data> element in the gc-regional.xml file with country values for the <specific> child element. Also includes appropriate country information values in the output directory structure. |