Calyx RIM for Registrations

Application Attributes

The attributes values that appear on the page depend on:

How you choose to create the application.
Whether you are creating a National, CP, DCP, or MRP application.
Whether you are creating a CTA or IND application or another type of application.

Use the following descriptions to help you choose and modify attribute values.


Attribute	Description
Actual Approval Date	When the application is first approved.
Actual Launch Date	Actual date of the product launch.
Actual Submission Date	When the application is submitted.
Annual Report Date	The date that the next annual report is due. This attribute is only for a CTA application.
Applicant ID	Identifies the entity that submits the application to regulatory authorities.
Application Add Comment	Comments you want to share with others in a discussion thread. Stamped with the date and time that you enter the information and your user ID.
Application Code	Agency-identified application number (or identifier). Might not be known until submittal time. For this reason, it can be the same as the internal code.
Application Comments	The discussion thread that includes all comments entered by users. Includes the date and time the comments were entered and the user IDs of the persons who entered them. Comments appear on the Modify Application Attributes page.
Application Concerned Parties	Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses.
Application Description	Text that describes the application.
Application Keywords	Words that you can use to search for the application.
Application Name	The name of the application.
Application Owner	The person responsible for creating the application.
Application Prefix	The prefix of the application.
Application Status	The status of the application. Note: The Application Status can be set to Withdrawn only when all Registrations associated to this Application have a status mapped to internal WITHDRAWN status.
Application Status Date	The date on which the current status was set.
Application Type	The type of application that you are creating. The application types that you can choose from are dependent on the reviewing country. The attributes displayed vary by the application type selected: CTA application or IND types have different attributes than all other application types. You cannot modify the application type in InSight after creating the application.
Arbitration	For CP, DCP, and MRP procedure type applications, indicates whether the application has been in arbitration.
Associated Products	The products to associate with the application. Available for RPT-licensed users only.
Clinical Trials #	The number used to identify the clinical trials assigned to the application.
Co-Rapporteur	For a CP application, the co-rapporteur associated with an application.
Countries	MRP/CP/Herbal/Homeopathic countries. When creating a new application, if the application procedure type is MRP, CP, Herbal or Homeopathic, you can add countries to the application as Concerned Member States (CMS). For CP procedure type applications, in addition to the individual countries that you add as CMS, you must also add the European Union to the application as a CMS.
Dossier Language	The language in which supporting documentation is written.
Family Code	The code assigned to the product family with which the application is associated.
Family Name	The name of the product family with which the application is associated.
IMPID	Investigational Medicinal Product Identifier for CTA and IND applications.
Last Role Change Date	When the country's role for the application date last changed.
Legal Basis	The legal basis for the authorisation of the product.
Legal Status	How the product is approved to be sold. Might be unavailable for ELP users.
Local PSUR Date	The date that the periodic safety report is due for this application.
Local PSUR Data Lock Date	The date up to which information must be compiled for the periodic safety report for this application.
Next Renewal Date	Date of the next renewal.
Orphan Drug	Indicates whether the drug treats a rare disease affecting less than 200,000 people in the reviewing country.
Orphan Drug Last Updated	The date on which the Orphan Drug attribute was last updated. This attribute is only for an IND application.
Planned Approval Date	When the application is to be approved for the first time.
Planned Launch Date	Expected date for the launch of the product.
Planned Submission Date	When the application is to be submitted for the first time.
Procedure Date End	The date when the procedure was completed. For National, MRP, DCP and CP applications.
Procedure Date Start	The date when the procedure commenced. For National, MRP, DCP and CP applications.
Procedure Identifier	The unique identifier for the specific instance of a procedure undertaken. For National, MRP, DCP and CP applications.
Procedure Type	Defines the strategy being used when applying for market approval: National, CP, DCP or MRP.
Product Family Type	The type of products associated with this product family, for example, pharmaceutical, medical device.
Reason	Reason for creating, modifying or deleting an application.
Reason for Comments	Comments related to reason entered by users.
Reason for Not Approving	The reason that the application was not approved. This attribute is only for a CTA application.
Reason for Premature Ending	The reason that the application ended prematurely. This attribute is only for a CTA application.
Reason for Termination/Withdrawal	The reason that the application was terminated or withdrawn.
Region(s)	The region of the world that is associated with the reviewing country. Provided automatically. The value displayed is a coma separated list that includes Region Type-Region pairs for the selected Reviewing Country. The list is alphabetical by region type.
Registration Type	When you create a registration, you associate it with an application. This attribute specifies whether the registrations you associate with the application will be of a registration type that is mapped to an internal value of either package set or product. Note: This attribute can be configured to default to one registration type and be non-editable.
Related Applications	Any applications to which the new application is related.
Reviewing Country	Primary country reviewing the application. For a CP application, this is the rapporteur. For an MRP or DCP application, this is the reference member state (RMS). For all other applications, it is the national country. The page refreshes to display the appropriate attributes for the country you choose. Note: Due to an Internet Explorer issue, when creating an application, if the keyboard arrow keys are used to navigate to the Reviewing Country field and then to select a country, duplicate values appear in the Application Type drop-down list.
Sponsor	The individual, company, institution, or organization that takes responsibility for the Clinical Trial's initiation, management and/or financing. Values for this come from the MAH/Sponsor/Legal Representative list. This is an attribute only for a CTA application. The value is presented in concatenation of MAH/Development Sponsor/Organisation Name, Address, City and Country Code
Starting Sequence Number	The number of the first sequence in the application, used if special permission by the agency allows starting on a sequence number other than 0000.
Study Number	Identifier for the study for which the CTA is created. This attribute is only for a CTA application.
Termination/Withdraw Date	The date when the application is terminated or withdrawn. Cannot be greater than today's date plus one day.
UUID	UUID is a universal unique identifier that is automatically generated by the system. This field is visible and available for modification only for countries that belong to the European Union or Undefined region. In the Application entity, the value can be modified only by users with Administrator permissions to the application, based on Application/Country rights. Through the eCTD wizard, users with appropriate permissions are able to modify the UUID to support Sequences that may require a different UUID than the remainder of the Application. In most cases, the UUID value should not change. Note: The UUID should contain 32 digits separated by 4 hyphens (xxxxxxxx-xxxx-xxxx-xxxx-xxxxxxxxxxxx).

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Application Attributes

The attributes values that appear on the page depend on:

How you choose to create the application.
Whether you are creating a National, CP, DCP, or MRP application.
Whether you are creating a CTA or IND application or another type of application.

Use the following descriptions to help you choose and modify attribute values.


Attribute	Description
Actual Approval Date	When the application is first approved.
Actual Launch Date	Actual date of the product launch.
Actual Submission Date	When the application is submitted.
Annual Report Date	The date that the next annual report is due. This attribute is only for a CTA application.
Applicant ID	Identifies the entity that submits the application to regulatory authorities.
Application Add Comment	Comments you want to share with others in a discussion thread. Stamped with the date and time that you enter the information and your user ID.
Application Code	Agency-identified application number (or identifier). Might not be known until submittal time. For this reason, it can be the same as the internal code.
Application Comments	The discussion thread that includes all comments entered by users. Includes the date and time the comments were entered and the user IDs of the persons who entered them. Comments appear on the Modify Application Attributes page.
Application Concerned Parties	Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses.
Application Description	Text that describes the application.
Application Keywords	Words that you can use to search for the application.
Application Name	The name of the application.
Application Owner	The person responsible for creating the application.
Application Prefix	The prefix of the application.
Application Status	The status of the application. Note: The Application Status can be set to Withdrawn only when all Registrations associated to this Application have a status mapped to internal WITHDRAWN status.
Application Status Date	The date on which the current status was set.
Application Type	The type of application that you are creating. The application types that you can choose from are dependent on the reviewing country. The attributes displayed vary by the application type selected: CTA application or IND types have different attributes than all other application types. You cannot modify the application type in InSight after creating the application.
Arbitration	For CP, DCP, and MRP procedure type applications, indicates whether the application has been in arbitration.
Associated Products	The products to associate with the application. Available for RPT-licensed users only.
Clinical Trials #	The number used to identify the clinical trials assigned to the application.
Co-Rapporteur	For a CP application, the co-rapporteur associated with an application.
Countries	MRP/CP/Herbal/Homeopathic countries. When creating a new application, if the application procedure type is MRP, CP, Herbal or Homeopathic, you can add countries to the application as Concerned Member States (CMS). For CP procedure type applications, in addition to the individual countries that you add as CMS, you must also add the European Union to the application as a CMS.
Dossier Language	The language in which supporting documentation is written.
Family Code	The code assigned to the product family with which the application is associated.
Family Name	The name of the product family with which the application is associated.
IMPID	Investigational Medicinal Product Identifier for CTA and IND applications.
Last Role Change Date	When the country's role for the application date last changed.
Legal Basis	The legal basis for the authorisation of the product.
Legal Status	How the product is approved to be sold. Might be unavailable for ELP users.
Local PSUR Date	The date that the periodic safety report is due for this application.
Local PSUR Data Lock Date	The date up to which information must be compiled for the periodic safety report for this application.
Next Renewal Date	Date of the next renewal.
Orphan Drug	Indicates whether the drug treats a rare disease affecting less than 200,000 people in the reviewing country.
Orphan Drug Last Updated	The date on which the Orphan Drug attribute was last updated. This attribute is only for an IND application.
Planned Approval Date	When the application is to be approved for the first time.
Planned Launch Date	Expected date for the launch of the product.
Planned Submission Date	When the application is to be submitted for the first time.
Procedure Date End	The date when the procedure was completed. For National, MRP, DCP and CP applications.
Procedure Date Start	The date when the procedure commenced. For National, MRP, DCP and CP applications.
Procedure Identifier	The unique identifier for the specific instance of a procedure undertaken. For National, MRP, DCP and CP applications.
Procedure Type	Defines the strategy being used when applying for market approval: National, CP, DCP or MRP.
Product Family Type	The type of products associated with this product family, for example, pharmaceutical, medical device.
Reason	Reason for creating, modifying or deleting an application.
Reason for Comments	Comments related to reason entered by users.
Reason for Not Approving	The reason that the application was not approved. This attribute is only for a CTA application.
Reason for Premature Ending	The reason that the application ended prematurely. This attribute is only for a CTA application.
Reason for Termination/Withdrawal	The reason that the application was terminated or withdrawn.
Region(s)	The region of the world that is associated with the reviewing country. Provided automatically. The value displayed is a coma separated list that includes Region Type-Region pairs for the selected Reviewing Country. The list is alphabetical by region type.
Registration Type	When you create a registration, you associate it with an application. This attribute specifies whether the registrations you associate with the application will be of a registration type that is mapped to an internal value of either package set or product. Note: This attribute can be configured to default to one registration type and be non-editable.
Related Applications	Any applications to which the new application is related.
Reviewing Country	Primary country reviewing the application. For a CP application, this is the rapporteur. For an MRP or DCP application, this is the reference member state (RMS). For all other applications, it is the national country. The page refreshes to display the appropriate attributes for the country you choose. Note: Due to an Internet Explorer issue, when creating an application, if the keyboard arrow keys are used to navigate to the Reviewing Country field and then to select a country, duplicate values appear in the Application Type drop-down list.
Sponsor	The individual, company, institution, or organization that takes responsibility for the Clinical Trial's initiation, management and/or financing. Values for this come from the MAH/Sponsor/Legal Representative list. This is an attribute only for a CTA application. The value is presented in concatenation of MAH/Development Sponsor/Organisation Name, Address, City and Country Code
Starting Sequence Number	The number of the first sequence in the application, used if special permission by the agency allows starting on a sequence number other than 0000.
Study Number	Identifier for the study for which the CTA is created. This attribute is only for a CTA application.
Termination/Withdraw Date	The date when the application is terminated or withdrawn. Cannot be greater than today's date plus one day.
UUID	UUID is a universal unique identifier that is automatically generated by the system. This field is visible and available for modification only for countries that belong to the European Union or Undefined region. In the Application entity, the value can be modified only by users with Administrator permissions to the application, based on Application/Country rights. Through the eCTD wizard, users with appropriate permissions are able to modify the UUID to support Sequences that may require a different UUID than the remainder of the Application. In most cases, the UUID value should not change. Note: The UUID should contain 32 digits separated by 4 hyphens (xxxxxxxx-xxxx-xxxx-xxxx-xxxxxxxxxxxx).