Calyx RIM 6.2 Release Notes

Entity Fields Added: Calyx RIM 6.2

The following tables describe new fields that were added to Calyx RIM 6.2.

Entities


Entity Name	Field Name	Field Type	Description	Business Rules
Full Product Presentation	Container or Pack Part	Text	The Container or Pack Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for The value. The database size of the field is VARCHAR2(500). For example: `DrugLV, collapsible aluminium tube`	N/A
	Countries	Multi-select list	All Package Set Countries available for selection. The field appears after the package set is selected in the Package Sets field.	For the application of National, Mutual Recognition (MRP) and Decentralised (DCP) Procedure types, the country of the parent Registration appears as selected by default.
	Device Part	Text	The Device Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV, solution for injection in pre-filled pen (device Tradename)`	N/A
	Flavour Part	Text	The Flavour Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV for Children Strawberry`	N/A
	Formulation Part	Text	The Formulation Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV, sugar free`	N/A
	Full Product Presentation Add Comment	Text	The free-format text box where users can add comments: You can enter up to 4000 characters. The database size is VARCHAR2(4000). The comments will be displayed in the Full Product Presentation Comments box followed by the date and time the comments were entered, and the user ID of the person who entered them.	Available on the Create/Modify Full Product Presentation pages only.
	Intended Use Part	Text	The Intended Use Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV 200 tablet Migraine`	N/A
	Target Population Part	Text	The Target Population Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV For Children`	N/A
	Time Period Part	Text	The Time Period Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV 300 mg EXPRESS`	N/A
Package Set Registration	Legal Basis	Drop-down list	The legal basis for an authorisation of the product. The Registration Attributes > Entity History Query and Querying > Administration > Entity Audit Trail queries have been updated to display the correct values for the new Legal Basis field.	All active values from Data Administration > Other > Legal Basis Values table are available for selection. The field is displayed for the Registration of a Package Set type only. The Registration > Legal Basis value is included to the XEVMPD Submission XML file instead of the Application > Legal Basis value, if: The field is populated with a value for both entities. The Application > Legal Basis field is not populated with a value
Product Detail Set	Local Route of Administration	Multi-select list	With Calyx RIM 6.2, a new configured field named Local Route of Administration has been added to the PDS Attributes page for tracking country Route of Administration on PDS level. The values available for selection in the Local Route of Administration multi-select list are the values from Product > Product Route of Administration and Component > Component Route of Administration fields, displayed as a concatenation of those values. If multiple components are presented, then each Component Route of Administration value is included in the concatenation. For more information on how the Route of Administration is tracked for XEVMPD, see XEVMPD Submission Wizard Data Collection Features. The field data is tracked in the XEVMPD Audit pre-defined Analytics report. The value is displayed under the Pharmaceutical Product-Administration Route XEVMPD Entity. The InSight Entity Type for the field is PDS.	The Local Route of Administration field is hidden by default and can be enabled via the overrides. If configured, the multi-select list is displayed as empty by default. This field is not displayed on the PDS Template attributes page.
Task	Related Task Name	Text (populated automatically, non-modifiable)	To provide the ability to identify the association between the parent Task and its Sub-Task, Calyx RIM 6.2 enhances the Task entity by adding a new field named Related Task Name. When a Task has an associated Sub-Task entity, the Related Task Name field for the Sub-Task will be automatically populated with the parent Task Name value. To support this enhancements, the following updates have been introduced: Several Registration Planning and Tracking reports have been updated. See Query Fields Added: Calyx RIM 6.2. The Related Task Name column has been added to the Querying > Administration > Entity Audit Trail > Query table when querying for the Task entity. The value is not hyperlinked. The Related Task Name column has been added to the Search Results page of the SEARCH functionality when invoked for the Tasks/Sub-tasks option.	The Related Task Name field value is hyperlinked. When selected, navigates you to the appropriate Task Attributes page. The Related Task Name field will always be empty for the parent Task entity.

Wizards


Wizard Name	Field Name	Field Type	Description	Business Rules
Copy Package Set Registration	Country	Drop-down list	For MRP (Mutual Recognition Procedure) and DCP (Decentralised Procedure) Application types, the Copy Package Set Registration wizard now provides the ability to select the country to copy the Package Set Registration while proceeding with the wizard pages. The Copy Package Set Registration wizard is updated with a new drop-down list named Country that appears on the following wizard pages: New Package Set specific Registration(s) > Select Product Detail Set page New Product specific Registration(s) > Copy License Code page The Country drop-down list is a required field. All Countries associated to the Application are available for selection. The field is populated by default with the Country value from the source Registration.	The Package Sets will be available only if the country selected in the Country drop-down list already has the assigned Registration.
Global Project Plan	Application Type	Multi-select list	To enhance the Global Project Plan wizard, the Application Type multi-select field has been added as an additional filter criterion. The following Global Project Plan wizard pages have been updated by adding the Application Type column: Create New Events Package Set Registration > Search by Product, Country and Application Status page Create New Events Product Registration > Search Country and Application Status page Update Product Detail Sets > Input Query Filter Criteria page, when searching by: Active Ingredient PDS Code/PDS Name Product and Country Substance Trade Name Withdraw Product Package Set Registration > Search by Product, Country Application and PDS Statuses page	The Application Type multi-select field depends on the selected countries and appears only after the selection is made in the Countries multi-select field.

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Entity Fields Added: Calyx RIM 6.2

The following tables describe new fields that were added to Calyx RIM 6.2.

Entities


Entity Name	Field Name	Field Type	Description	Business Rules
Full Product Presentation	Container or Pack Part	Text	The Container or Pack Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for The value. The database size of the field is VARCHAR2(500). For example: `DrugLV, collapsible aluminium tube`	N/A
	Countries	Multi-select list	All Package Set Countries available for selection. The field appears after the package set is selected in the Package Sets field.	For the application of National, Mutual Recognition (MRP) and Decentralised (DCP) Procedure types, the country of the parent Registration appears as selected by default.
	Device Part	Text	The Device Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV, solution for injection in pre-filled pen (device Tradename)`	N/A
	Flavour Part	Text	The Flavour Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV for Children Strawberry`	N/A
	Formulation Part	Text	The Formulation Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV, sugar free`	N/A
	Full Product Presentation Add Comment	Text	The free-format text box where users can add comments: You can enter up to 4000 characters. The database size is VARCHAR2(4000). The comments will be displayed in the Full Product Presentation Comments box followed by the date and time the comments were entered, and the user ID of the person who entered them.	Available on the Create/Modify Full Product Presentation pages only.
	Intended Use Part	Text	The Intended Use Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV 200 tablet Migraine`	N/A
	Target Population Part	Text	The Target Population Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV For Children`	N/A
	Time Period Part	Text	The Time Period Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: `DrugLV 300 mg EXPRESS`	N/A
Package Set Registration	Legal Basis	Drop-down list	The legal basis for an authorisation of the product. The Registration Attributes > Entity History Query and Querying > Administration > Entity Audit Trail queries have been updated to display the correct values for the new Legal Basis field.	All active values from Data Administration > Other > Legal Basis Values table are available for selection. The field is displayed for the Registration of a Package Set type only. The Registration > Legal Basis value is included to the XEVMPD Submission XML file instead of the Application > Legal Basis value, if: The field is populated with a value for both entities. The Application > Legal Basis field is not populated with a value
Product Detail Set	Local Route of Administration	Multi-select list	With Calyx RIM 6.2, a new configured field named Local Route of Administration has been added to the PDS Attributes page for tracking country Route of Administration on PDS level. The values available for selection in the Local Route of Administration multi-select list are the values from Product > Product Route of Administration and Component > Component Route of Administration fields, displayed as a concatenation of those values. If multiple components are presented, then each Component Route of Administration value is included in the concatenation. For more information on how the Route of Administration is tracked for XEVMPD, see XEVMPD Submission Wizard Data Collection Features. The field data is tracked in the XEVMPD Audit pre-defined Analytics report. The value is displayed under the Pharmaceutical Product-Administration Route XEVMPD Entity. The InSight Entity Type for the field is PDS.	The Local Route of Administration field is hidden by default and can be enabled via the overrides. If configured, the multi-select list is displayed as empty by default. This field is not displayed on the PDS Template attributes page.
Task	Related Task Name	Text (populated automatically, non-modifiable)	To provide the ability to identify the association between the parent Task and its Sub-Task, Calyx RIM 6.2 enhances the Task entity by adding a new field named Related Task Name. When a Task has an associated Sub-Task entity, the Related Task Name field for the Sub-Task will be automatically populated with the parent Task Name value. To support this enhancements, the following updates have been introduced: Several Registration Planning and Tracking reports have been updated. See Query Fields Added: Calyx RIM 6.2. The Related Task Name column has been added to the Querying > Administration > Entity Audit Trail > Query table when querying for the Task entity. The value is not hyperlinked. The Related Task Name column has been added to the Search Results page of the SEARCH functionality when invoked for the Tasks/Sub-tasks option.	The Related Task Name field value is hyperlinked. When selected, navigates you to the appropriate Task Attributes page. The Related Task Name field will always be empty for the parent Task entity.

Wizards


Wizard Name	Field Name	Field Type	Description	Business Rules
Copy Package Set Registration	Country	Drop-down list	For MRP (Mutual Recognition Procedure) and DCP (Decentralised Procedure) Application types, the Copy Package Set Registration wizard now provides the ability to select the country to copy the Package Set Registration while proceeding with the wizard pages. The Copy Package Set Registration wizard is updated with a new drop-down list named Country that appears on the following wizard pages: New Package Set specific Registration(s) > Select Product Detail Set page New Product specific Registration(s) > Copy License Code page The Country drop-down list is a required field. All Countries associated to the Application are available for selection. The field is populated by default with the Country value from the source Registration.	The Package Sets will be available only if the country selected in the Country drop-down list already has the assigned Registration.
Global Project Plan	Application Type	Multi-select list	To enhance the Global Project Plan wizard, the Application Type multi-select field has been added as an additional filter criterion. The following Global Project Plan wizard pages have been updated by adding the Application Type column: Create New Events Package Set Registration > Search by Product, Country and Application Status page Create New Events Product Registration > Search Country and Application Status page Update Product Detail Sets > Input Query Filter Criteria page, when searching by: Active Ingredient PDS Code/PDS Name Product and Country Substance Trade Name Withdraw Product Package Set Registration > Search by Product, Country Application and PDS Statuses page	The Application Type multi-select field depends on the selected countries and appears only after the selection is made in the Countries multi-select field.