Ennov InSight RIM 7.1 RNs Cumulative

Entity Fields and Columns Added: Ennov InSight 7.1

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Entities

The following table describe fields and columns that were added in this release. These include the fields and column that were added to support IDMP data capture.

Table 1. Product Family
Field/Option Name Field Type Description Business Rules
  • Product Family Comorbidity
  • EURD ID
Drop-down list, multi-select The Product Family Attributes page now includes the respective fields. The Product Family Comorbidity field displays values from Data Administration > Other > Indications/Intended Use Values.

The EURD ID field displays values from Data Administration > Product Family Maintenance > EURD ID Values.

Table 2. Application
Field/Option Name Field Type Description Business Rules
  • Reporting Member State
  • Region(s)
  • UUID
  • Applicant ID
  • Application Code
  • Study Number
  • Legal Basis
  • Application Type
  • Procedure Type
  • Registration Type
  • Co-Rapporteur
  • Associated Products
  • IMPID
  • Arbitration
  • Application Owner
  • Orphan Drug
  • Orphan Drug Last Updated
  • Annual Report Date
  • Application Status
  • Application Status Date
  • Local PSUR Date
  • Local PSUR Data Lock Date
  • Termination/Withdraw Date
  • Reason for Termination/Withdrawal
  • Countries
  • Sponsor
  • Reason for Not Approving
  • Reason for Premature Ending
  • Application Concerned Parties
  • Application Keywords
  • Application Description
  • Application Comments
Drop-down list, text field, date, multi-select The Application Attributes page for the new EU Clinical Trial Regulation Application Type now includes the respective fields. To capture EU Clinical Trial data in Ennov InSight as required by EU 536/2014 regulation, the new EU Clinical Trial Regulation type of Application is introduced.
  • Application Name
  • Application Code
  • Country
  • Role
  • Sequences
  • Planned Submission Date
  • Actual Submission Date
  • Planned Approval Date
  • Actual Approval Date
  • Withdrawn Date
  • Last Role Change Date
  • Local Start of Trial Date
  • Local First Visit of First Subject Date
  • Local End of Recruitment Date
  • Local End of Trial Date
  • Local Temporary Halt Date
  • Local Restart of Temporarily Halted Trial Date
  • Local Early Termination/Withdrawal/Suspension Date
  • Local Early Termination/Withdrawal/Suspension Reason
  • Application Country Concerned Parties
  • Application Country Keywords
  • Application Country Description
  • Application Country Comments
  • Member States Concerned
Drop-down list, text field, date, multi-select The Application Counry Attributes page for the new EU Clinical Trial Regulation Application Type now includes the respective fields. N/A
Table 3. Event - Country Status, Sequence Status Dates, and Task Status Dates
Field/Option Name Field Type Description Business Rules
  • Add Comment
  • Event-Country Status Comments
  • Sequence Status Comments
  • Task Status Comments
Text field These pages now include the respective fields:
  • Event-Country Attributes > Status Dates > Add Event-Country Status
  • Event-Country Attributes > Status Dates > Modify Event-Country Status
  • View Sequence > Status Dates > Add Status
  • View Sequence > Status Dates > Modify Status
  • View Task > Status Dates > Add Status
  • View Task > Status Dates > Modify Status
You can use this option to record comments for create/modify actions on Event - Country Status, Sequence Status Date, and Task Status Dates.
  • Event-Country Status Comments in Event- Country Attributes > Add/Modify-Country Event Status.
  • Sequence-Status Comments in View Sequence > Add/Modify Status.
  • Task Status Comments in View Task > Add/Modify Status.
Table 4. Component
Field/Option Name Field Type Description Business Rules
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Drop-down list, text field The Component field is included in the Active Ingredient Attributes and Reference Active Ingredient Attributes pages:
  • Component > Active Ingredient Attributes
  • Component > Reference Active Ingredient Attributes
N/A
Table 5. Manufactured Item
Field/Option Name Field Type Description Business Rules
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Component Name
  • Manufactured Item Name
  • Unit of Presentation
  • Manufactured Item Quantity
  • Manufactured Item Quantity Unit
  • Manufactured Dose Form
  • Manufactured Item Characteristics/Description
  • Manufactured Item Concerned Parties
  • Manufactured Item Keywords
  • Manufactured Item Description
  • Manufactured Item Comments
  • Manufactured Item Add Comment
Display- Hyperlink, read-only text , drop-down list, multi-select , text field, widget The Manufactured Item entity tab is added under Component and includes all the respective fields. The values for the Manufactured Item Quantity Unit field is available from the Data Administration > SPOR Master Lists > Unit of Measurement values.
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Component Name
  • Manufactured Item Name
  • Active Ingredient Name
  • Strength Same as Component?
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Display- Hyperlink, read-only text , drop-down list, multi-select, text field The Active Ingredients entity tab is added under Manufactured Item Attributes and includes all the respective fields. N/A
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Component Name
  • Manufactured Item Name
  • Active Ingredient Name
  • Reference Active Ingredient Name
  • Strength Same as Component?
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Display- Hyperlink, read-only text , drop-down list, multi-select editable, text field The Reference Active Ingredients entity tab is added under Manufactured Item > Active Ingredients and includes all the respective fields. N/A
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Component Name
  • Manufactured Item Name
  • Substance Name
  • Substance Type
  • Strength Same as PDS Substance?
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Display- Hyperlink, read-only text , drop-down list, multi-select, text field The Substances entity tab is added under Manufactured Item Attributes and includes all the respective fields. N/A
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Component Name
  • Manufactured Item Name
  • Reference Substance Name
  • Substance Name
  • Substance Type
  • Strength Same as PDS Substance?
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Display- Hyperlink, read-only text , drop-down list, multi-select, text The Reference Substances entity tab is added under Manufactured Item > Substances and includes all the respective fields. N/A
Table 6. Orphan Designation
Field/Option Name Field Type Description Business Rules
  • Application Code
  • Application Name
  • Indications
  • Number
  • Orphan Status
  • Orphan Status Date
  • Community Registered Orphan Indication
  • Market Exclusivity Start Date
  • Orphan Designation Keywords
  • Orphan Designation Description
  • Orphan Designation Comments
Display- Hyperlink, read-only text , drop-down list, multi-select, text field, date The Orphan Designation entity tab is added under Application and includes all the respective fields. This tab shows if:
  • The Application type is Marketing Authorization Application (MAA).
  • The Application country belongs to EMA.
  • The Orphan Drug flag on the Application Attributes page is set to Yes.
N/A
Table 7. Product Detail Sets
Field/Option Name Field Type Description Business Rules
  • Device - Type of Combination
  • Device Type
  • Device Identifier
  • Device Trade Name
Drop-down list, text field The Add Medical Device page now includes Device - Type of Combination field.

The Add Medical Device page now includes all the respective fields.

The name of the device should be specified, if applicable, as recorded in the European database on medical devices (EUDAMED).

The Unique Device Identifier recorded in the European database on medical devices (EUDAMED) must be specified.

Manufacturing Operation Start Date Date The Add/Edit Manufacturer page now includes this field. The Manufacturing Operation Start Date is populated with the current date when the status of detail is changed from Pending to Approved. You can update this field even when the value is automatically populated .
Manufacturing Operation Stop Date Date The Add/Edit Manufacturer page now includes this field. The Manufacturing Operation Start Date automatically populates the date on which the status of detail is changed from Pending Withdrawal to Withdrawn. You can update this field even when the value is automatically populated.
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Drop-down list, text field The following pages now includes the respective fields:
  • Product Detail Set > Substance Detail Attributes
  • Product Detail Set Template > Substance Detail Attributes
  • Product Detail Set > Flu Strain Attributes
  • Product Detail Set Template > Flu Strain Attributes
N/A
  • Application Code
  • Application Name
  • Family Code
  • Family Name
  • Product Name
  • Product Detail Set Name
  • Pack Size Value
  • Unit of Presentation
  • QC Status
  • Date QC'd
  • QC'd by
  • Pack Size Status
  • Pack Size Status Date
  • Pack Size Keywords
  • Pack Size Description
  • Pack Size Comments
Read-only text (populated automatically), Numeric, Drop-down list, Date, Text field The Package Set > Pack Size > Add Pack Size page and Package Set > Pack Size > Edit Pack Size page includes the respective fields. N/A
Intended Effect Multi-select The Indication/Intended Use PDS AttributesIndication/Intended Use (Add/Modify/Delete/View) pages now includes the Intended Effect field. The Intended Effect field displays values from Data Administration > Product Detail Maintenance > Intended Effect Values.
Comorbidity Multi-select The Indication/Intended Use PDS AttributesIndication/Intended Use (Add/Modify/Delete/View) pages now includes the Comorbidity field. The options for selection are displayed from the selected list values of the Product Family Comorbidity field on the Product Family page.
  • Package Item Container Quantity
  • Package Material
  • Package Alternate Material
  • Package Components
  • Manufactured Item Reference
  • Packaging MI Quantity
  • Packaging MI Quantity Unit
  • Medical Device Reference
  • Device Quantity
Numeric, Multi-select, Drop-down list The Package Detail (Add/Edit) pages now includes the respective fields. The values for the Packaging MI Quantity Unit field is available from the Data Administration > Other > Units of Measurement Values.

The Medical Device Reference field is displayed only for the Medical Device and Pharmaceutical-Medical Device product family types. This field populates Medical Device Detail. To delete Medical Device Detail, you must first delete all the references in the Packaging Detail.

Table 8. Product
Field/Option Name Field Type Description Business Rules
  • Combined Pharmaceutical Dose Form
  • Product Category
  • EURD ID
Drop-down list, multi-select, read-only text (populated automatically) The Product Attributes page now includes the respective fields. The Combined Pharmaceutical Dose Form field shows on the View/Modify Product Attributes page when more than one component is associated. The active Dosage/Pharmaceutical Form Data Administration values with RMS values assigned mapped to values from SPOR Master Lists > Combined Pharmaceutical Dose Form appear for this field.
Table 9. Pharmaceutical Product
Field/Option Name Field Type Description Business Rules
Route of Administration Multi-select The Pharmaceutical Product Attributes page now includes the respective field. N/A
Pharmaceutical Product Summary Read-only text (populated automatically) The Pharmaceutical Product Attributes page now includes the respective field. By default, the field is hidden. N/A
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Pharmaceutical Product Name
  • Active Ingredient Name
  • Strength Same as Component?
  • Exclude from IDMP Submission
  • Concentration Measure Type
  • Low Amount Numerator Value
  • Low Amount Numerator Prefix
  • Low Amount Numerator Unit
  • Low Amount Denominator Value
  • Low Amount Denominator Prefix
  • Low Amount Denominator Unit
  • High Amount Numerator Value
  • High Amount Numerator Prefix
  • High Amount Numerator Unit
  • High Amount Denominator Value
  • High Amount Denominator Prefix
  • High Amount Denominator Unit
  • Measurement Point
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Display- Hyperlink, read-only text , drop-down list, multi-select, text field The Active Ingredients entity tab is added under Pharmaceutical Product Attributes and includes all the respective fields. N/A
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Pharmaceutical Product Name
  • Active Ingredient Name
  • Reference Active Ingredient Name
  • Strength Same as Component?
  • Exclude from IDMP Submission
  • Concentration Measure Type
  • Low Amount Numerator Value
  • Low Amount Numerator Prefix
  • Low Amount Numerator Unit
  • Low Amount Denominator Value
  • Low Amount Denominator Prefix
  • Low Amount Denominator Unit
  • High Amount Numerator Value
  • High Amount Numerator Prefix
  • High Amount Numerator Unit
  • High Amount Denominator Value
  • High Amount Denominator Prefix
  • High Amount Denominator Unit
  • Measurement Point
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Display- Hyperlink, read-only text , drop-down list, multi-select, text field, widget The Reference Active Ingredients entity tab is added under Pharmaceutical Product > Active Ingredients and includes all the respective fields. N/A
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Pharmaceutical Product Name
  • Component Name
  • Substance Name
  • Substance Type
  • Strength Same as PDS Substance?
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Display- Hyperlink, read-only text , drop-down list, multi-select, text field The Substances entity tab is added under Pharmaceutical Product Attributes and includes all the respective fields. N/A
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Pharmaceutical Product Name
  • Component Name
  • Substance Name
  • Reference Substance Name
  • Substance Type
IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Display- Hyperlink, read-only text , drop-down list, multi-select, text field, widget The Reference Substances entity tab is added under Pharmaceutical Product > Substances and includes all the respective fields. N/A
  • Family Type
  • Family Code
  • Family Name
  • Product Name
  • Pharmaceutical Product Name
  • PhPID
Display- Hyperlink, read-only text,text field The PhPIDs entity tab is added under Pharmaceutical Product and includes all the respective fields. N/A
Table 10. Registrations
Field/Option Name Field Type Description Business Rules
  • Application Code
  • Application Name
  • License Code
  • MAH/Organisation
  • Medicinal Product Name
  • Product
  • Package Sets
  • Authorised Pharmaceutical Form
  • Pediatric Use Indicator
  • Genetically Modified Organisms
  • PMS ID
  • Full Indication Text
  • Pharmaceutical Products
  • Medicinal Product Keywords
  • Medicinal Product Description
  • Medicinal Product Comments
Display- Hyperlink, read-only text , drop-down list, multi-select editable, text field, widget The Medicinal Product (Create/View/Modify) page includes the respective fields. N/A
  • Application Code
  • Application Name
  • Container or Pack Part
  • Country
  • Delimiter Part
  • Device Part
  • Flavour Part
  • Formulation Part
  • Full Name
  • Intended Use Part
  • Invented Name Part
  • Language
  • License Code
  • Medicinal Product Name
  • Medicinal Product Name Comments
  • Medicinal Product Name Description
  • Medicinal Product Name Keywords
  • Pharmaceutical Dosage Form Part
  • Scientific Name Part
  • Strength Part
  • Target Population Use Part
  • Trademark or Company Name Part
  • Time/Period Part
Display- Hyperlink, read-only text , drop-down list, multi-select, text field The Medicinal Product Name (Create/View/Modify) page includes the respective fields. N/A
  • MPID
  • Version
  • Version Date
Read-only text, date The MPID tab page includes the following columns. The information on the MPID tab is read-only. The MPID tab appears under Medicinal Product Attributes. N/A
  • Pharmaceutical Product Name
  • Pharmaceutical Product Summary
Display- Hyperlink, read-only text The Pharmaceutical Product tab page includes these columns. The Pharmaceutical Product tab appears under Medicinal Product Attributes with the ability to associate/disassociate the pharmaceutical products. N/A
  • Application Code
  • Application Name
  • License Code
  • MAH/Organisation
  • Sequence
  • Events
  • Medicinal Product
  • Regulatory Application Submission Type
  • Event Variation Number
  • Event EU Grouping/Worksharing
  • Regulatory application Identifier/Number
  • FHIR Protocol Type
  • Action Name
  • Content of Change
  • Provenance Reason
  • Status
  • Status Date
  • Medicinal Product Action Keywords
  • Medicinal Product Action Description
  • Medicinal Product Action Comments
Display- Hyperlink, read-only text , drop-down list, multi-select , text field, date The Medicinal Product Action (Create/View/Modify) page includes the following fields. The values for the Regulatory Application Submission Type fields are available from the Data Administration > Other > Application Submission Type values.
The Event field is displayed only with the following conditions:
  • CP Applications:
    • Event is Open+Event is Closed with APPROVED status (status should be only APPROVED).
    • Event Closed Date should not be greater than 31 days.
    • Event Country = Registration Country.
  • Non-CP Applications:
    • Event is Closed with APPROVED status(status should be only APPROVED)(Open Events should not be displayed).
    • Event Closed Date should not be greater than 31 days.
    • Event Country = Registration Country.
  • Application Code
  • Application Name
  • License Code
  • Sequence
  • Medicinal Product List
  • Attached Document Identifier (Master)
  • Attached Document Name
  • Attached Document Type
  • Alternate Identifier (EV Code)
  • Title
  • Content Type
  • Content Link
  • Effective Date
  • Language
  • Full Indication Text
Display- Hyperlink, read-only text , drop-down list, multi-select, text field, date The Attached Documents (Create/View/Modify) page includes the respective fields. The Attached Documents tab appears for Applications of MRP, DCP, EU National Type only.
  • Application Code
  • Application Name
  • License Code
  • Product Name
  • Medicinal Product Name
  • MPID
  • Version
  • Version Date
Display- Hyperlink, read-only text The IDMP page includes the following columns. The information on the IDMP tab is read-only. The IDMP tab appears under Registration Attributes when the Medicinal Product is created. N/A
  • Application Code
  • Application Name
  • License Code
  • Product Detail Set Name
  • Package Set Name
  • Short Package Description
  • Package Description
  • Language
  • Package Description
  • Package Description Description
  • Package Description Comments
Hyperlink, drop-down list, text field The Package Descriptions entity is added under Registration-Package Set Attributes and includes all the respective fields. N/A
  • Legal Basis
  • Authorisation Status
  • Authorisation Status Date
  • Status
  • Status Date
  • PCID
  • Package Set License Code
  • Withdrawn
  • Withdrawn Date
Drop-down list, text field, date The Registration- Package Sets Attributes page now includes the respective fields. N/A
  • Package Set Name
  • Package Set License Code
  • Product Detail Set Name
  • Product Detail Set Code
  • Status
  • Status Date
  • Authorisation Status
  • Authorisation Status Date
  • PCID
  • MPID
Hypelink, text field, date The Package Sets tab grid view on the Registration Attributes page for Package Set Registration type now includes the respective columns. N/A
  • ATC Code Flag
Drop-down list The Registration Attributes page for Package Set Registration type now includes the respective fields. N/A
Table 11. Full Product Presentation
Field/Option Name Field Type Description Business Rules
Pharmaceutical Products Multi-select, read-only text (populated automatically) The Create Full Product Presentation page now includes the Pharmaceutical Products field:
  • Create Full Product Presentation
  • Copy Full Product Presentation(under Same Registrations)
Only Pharmaceutical Products from Products that are associated to FPP via Pack Sets are displayed in the Pharmaceutical Products field.

Pharmaceutical Product value is displayed as a concatenation of Pharmaceutical Product Name and Pharmaceutical Product Summary.

Wizards

Table 12. Create Notification Wizard
Field Name Field Type Description Business Rules
Available Options Drop-down list The Available Options field under the Select Rule Settings and Delivery Destinations step now includes the following options for selection:
  • Community Registered Orphan Designation Indication
  • Indications
  • Market Exclusivity Start Date
  • Number
  • Orphan Status
  • Orphan Status Date
These options are available for selection when you:
  • set Orphan Drug flag to Yes.
  • select When a Value Changes option under the Choose Notification Type step.
Application Status Drop-down list The Application Status field under the Select Rule Settings and Delivery Destinations step now includes the Orphan Status option for selection. This option is available for selection when you:
  • set Orphan Drug flag to Yes.
  • select When Status Changes to a Specific Value option under the Choose Notification Type step.
Available Options Drop-down list The Available Options field under the Select Rule Settings and Delivery Destinations step now includes the Orphan Status Date option for selection. These options are available for selection when you:
  • set Orphan Drug flag to Yes.
  • select When a Date Approaches or Passes option under the Choose Notification Type step.
Available Options Drop-down list The Available Options field under the Select Rule Settings and Delivery Destinations step now includes the following options for selection for the Product Family Attributes when creating notifications:
  • EURD ID
  • Product Family Indications
  • Product Family Comorbidity
  • Product Family Indications/Intended Use
These options are available for selection, when you select When a Value Changes option under the Choose Notification Type step.
Available Options Drop-down list The Available Options field under the Select Rule Settings and Delivery Destinations step now includes the following option for selection for the Application Country Attributes when creating notifications for EU CTR applications only: Local Early Termination/Withdrawal/Suspension Reason. This option is available for selection when you select the When a Value Changes option in the Choose Notification Type step.
Available Options Drop-down list The Available Options field under Select Rule Settings and Delivery Destinations now includes the following options for the Application Country attributes when creating notifications for EU CTR applications only:
  • Local Start of Trial Date
  • Local First Visit of First Subject Date
  • Local End of Recruitment Date
  • Local End of Trial Date
  • Local Temporary Halt Date
  • Local Restart of Temporarily Halted Trial Date
  • Local Early Termination/Withdrawal/Suspension Date
This option is available for selection when you select the When a Date Approaches or Passes option in the Choose Notification Type step.