Ennov InSight RIM 7.1 RNs Cumulative

Data Administration Tables Added: Ennov InSight 7.1

The following Data Administration tables, sections, or fields were added for Ennov InSight 7.1. These include the tables added to support IDMP data capture.

Data Administration Section: Product Family Maintenance

Table 1. Domain Type Values
Entity Affected	Field Name	Value List Description
Product Family	Domain Name	To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, the Domain Type Values table is introduced. The value for Domain Name can be entered in the respective field.

Table 2. EURD ID Values
Entity Affected	Field Name	Value List Description
Product Family	EURD Procedure Identifier EURD ID	To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, the EURD ID Values table is introduced. The values for EURD Procedure Identifier and EURD ID can be entered in their respective fields.

Data Administration Section: Product Maintenance

Table 3. Product Category Type Values
Entity Affected	Field Name	Value List Description
Product Family	Product Category Type Name	The classification of the medicinal products.

Table 4. Product Cross Reference Type Values
Entity Affected	Field Name	Value List Description
Product Family	Product Cross Reference Type Name	The type of medicinal product (MP) that is referenced. You can define it using a term ID.

Table 5. Dosage/Pharmaceutical Form Values
Entity Affected	Field Name	Value List Description
N/A	FDA Code EV Code RMS Term ID	The Dosage/Pharmaceutical Form Values now includes the respective new columns.

Data Administration Section: Other

Table 6. Application Submission Type Values
Entity Affected	Field Name	Value List Description
Sequences, Events	Application Submission Type Name	A marketing authorisation application. You can define it using a term ID.

Table 7. Attached Document Content Type Values
Entity Affected	Field Name	Value List Description
Attached Document	Attached Document Content Type Name	This is a new DA list that will be mapped to RMS list Product Information Document Type. Product Information Document Type is a new RMS list and will be introduced in the next upcoming release.

Table 8. Units of Measurement Values
Entity Affected	Field Name	Value List Description
Manufactured Item, PDS Packaging Detail	Units of Measurement Name	Provide the strength (quantitative composition) of the substances (including active substances, ingredients, solvents, adjuvant as applicable) in this field with a numerator and denominator value.

Data Administration Section: Application Maintenance

Table 9. Regulatory Entitlement Type Values
Entity Affected	Field Name	Value List Description
Application	Regulatory Entitlement Type	To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, the Reguatory Entitlement Type Values table is introduced. The values for Regulatory Entitlement Type can be entered in the respective fields.

Table 10. Orphan Status Values
Entity Affected	Field Name	Value List Description
Application	Orphan Status Name	Orphan status. For example: Expired, Pending, Valid, Withdrawn.

Table 11. Product Information Document Type Values
Entity Affected	Field Name	Value List Description
Application	Product Information Document Type Name	The document that contains the medicinal products details.

Data Administration Section: SPOR Master Lists

Table 12. Units of Measurement
Data Administration Table Name	Entity Affected	Field Name	Value List Description
Units of Measurement	N/A	N/A	The strength (quantitative composition) of the substances (including active substances, ingredients, solvents, adjuvant as applicable) must be specified in this field with a numerator and denominator.

Table 13. Units of Presentation
Entity Affected	Field Name	Value List Description
N/A	N/A	The strength (quantitative composition) of the substances (including active substances, ingredients, solvents, adjuvant as applicable) must be specified in this field with a numerator and denominator.

Table 14. XEVMPD Medical Devices
Data Administration Table Name	Entity Affected	Field Name	Value List Description
XEVMPD Medical Devices	N/A	N/A	Includes details of the XEVMPD Medical Devices.

Table 15. XEVMPD Medicinal Product Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the XEVMPD medicinal product type.

Table 16. Anatomical Therapeutic Chemical Classification System - Human
Entity Affected	Field Name	Value List Description
N/A	N/A	The Anatomical Therapeutic Chemical Classification System - Human table is introduced to provide the ATC code as indicated as Pharmacodynamic properties of the corresponding SmPC. As a term ID you must provide the regulatory documents.

Table 17. Country
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the medicinal product name that has been authorized as approved by the regulatory authority.

Table 18. Legal Status for the Supply
Entity Affected	Field Name	Value List Description
N/A	N/A	Provides the status of the medicinal product supply as authorized by the relevant competent authority.

Table 19. Manufacturing Activity
Entity Affected	Field Name	Value List Description
N/A	N/A	Provides details of the active substance manufacturer including active substance manufacturers.

Table 20. Marketing Status
Entity Affected	Field Name	Value List Description
N/A	N/A	Indicates the marketing status of medicinal products.

Table 21. Master File Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Indicates the Master File used.

Table 22. Domain
Entity Affected	Field Name	Value List Description
N/A	N/A	Helps to differentiate whether the type of medicinal product is for human or for veterinary use.

Table 23. Combination Package
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the pharmaceutical form that is submitted for authorization or is authorized by the regulatory authorities. These details are reflected in the regulatory documents.

Table 24. Pharmaceutical Dose Form
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the manufactured dose form described with the authorized pharmaceutical form(s). Pharmaceutical Form of the SmPC or other regulatory document.

Table 25. Combined Pharmaceutical Dose Form
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the combination of the two or more manufactured dose form described with the authorized pharmaceutical form(s). Pharmaceutical Form of the SmPC or other regulatory document.

Table 26. Combined Term
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the combined term for medicinal products.

Table 27. Medicinal Product Name Part Type
Entity Affected	Field Name	Value List Description
N/A	N/A	The medicinal product name parts are specified along with the language of the country as per the marketing authorisation applies in accordance with the referenced SmPC.

Table 28. Packaging
Entity Affected	Field Name	Value List Description
N/A	N/A	Details of the of the medicinal products packing.

Table 29. Product Category
Entity Affected	Field Name	Value List Description
N/A	N/A	Classification of the products.

Table 30. Contact Party Role
Entity Affected	Field Name	Value List Description
N/A	N/A	Type of contact in the context of the Medicinal Product that must be specified.

Table 31. Quantity Operator
Entity Affected	Field Name	Value List Description
N/A	N/A	Indicates the strength of the substance ingredient(s) contained in the medicinal product.

Table 32. Routes and Methods of Administration
Entity Affected	Field Name	Value List Description
N/A	N/A	The method and path of drug administration.

Table 33. Special Precaution for Storage
Entity Affected	Field Name	Value List Description
N/A	N/A	Indicates the precautions taken for storing and stacking drugs.

Table 34. Application Legal Basis
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the classification value of a medicinal product.

Table 35. Application Submission Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the type of the marketing authorization application that is described using the term id.

Table 36. Regulatory Entitlement Type
Entity Affected	Field Name	Value List Description
N/A	N/A	The type of regulatory authorization.

Table 37. Regulatory Entitlement Status
Entity Affected	Field Name	Value List Description
N/A	N/A	The status of the marketing authorization.

Table 38. Shelf Life Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Shelf life types such as shelf life of the Packaged Medicinal Product itself, shelf-life after transformation, etc.

Table 39. Product Information Document Type
Entity Affected	Field Name	Value List Description
N/A	N/A	The type of contact that must be specified in the context of the Medicinal Product.

Table 40. Material
Entity Affected	Field Name	Value List Description
PDS	List Id List Name List Owner Term Id Term Name Short Name Status Domain Modified On Mapping Source Source Term Id xEVMPD Code Description Comments Version Number ISO Code	Defines the material(s) of the package item. This Material RMS list is mapped to the Data Administration > Product Detail Set Maintenance > Product Materials Values .

Table 41. Medical Dictionary For Regulatory Activities
Entity Affected	Field Name	Value List Description
N/A	N/A	Comorbidity, intended effect and indication details used for the medicinal products.

Table 42. Product Cross Reference Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the Product Cross Reference Types.

Table 43. EU Regulatory Authorisation Procedure
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the regulatory procedure applied to grant or amend a marketing authorization for a Medicinal Product.

Table 44. Ingredient Role
Entity Affected	Field Name	Value List Description
N/A	N/A	Role of the active ingredient as part of the manufactured item/pharmaceutical product.

Table 45. Language
Entity Affected	Field Name	Value List Description
N/A	N/A	Language of the medicinal product name for the specified country, as approved by the regulatory authority.

Table 46. Organisation (OMS)
Entity Affected	Field Name	Value List Description
N/A	N/A	The Organisation SPOR Master List consists of organisations and locations from the EMA Organisation Management Services (OMS).

Table 47. Data Classification
Entity Affected	Field Name	Value List Description
N/A	N/A	The Data Classification is a RMS list and is used to populate the Confidentiality Indicator field available on the Data Administration > Manufacturer Values > Global Detail Sets Attributes page.

Data Administration Section: Product Detail Set Maintenance

Table 48. Device - Type of Combination Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Device - Type of Combination Name	This value supports IDMP.

Table 49. Package Component Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Component Type Product Material	This value supports IDMP.

Table 50. Component Type Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Component Type Name	This value supports IDMP.

Table 51. Intended Effect Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Intended Effect	This value supports IDMP.

Table 52. Medical Device UDI Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Medical Device UDI Name	This Data Administration table is used to populate the Device Type field for PDS Component - Medical Devices. This Data Administration list is mapped to the Device Type value in the SPOR RMS list section.

Table 53. Manufacturing Function Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Manufacturing Function Name	This Data Administration table is used to populate the Function Name field for PDS- Function. This Data Administration list is mapped to the Manufacturing Activity value in the SPOR RMS list section.

Table 54. Data Classification Type Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Data Classification Type Name	This Data Administration table is used to populate the Confidentiality Indicator field on the Data Administration Manufacturer Values - Data Administration Manufacturer Values > Global Product Details > Global Detail Sets.

Data Administration Section: Registration Maintenance

Table 55. Content of Change Values
Entity Affected	Field Name	Value List Description
Registrations	Content of Change Name	This Content of Change provided for the IDMP attachment.

Table 56. Data Carrier Type Values
Entity Affected	Field Name	Value List Description
Registrations	Data Carrier Type Name	This table is used to display the value for the Data Carrier Type field for the Registration Package Set Country.

Table 57. Provenance Reason Values
Entity Affected	Field Name	Value List Description
Registrations	Provenance Reason Name	The reason of the activity of medicinal product data submission in the Postmarketing surveillance (PMS).

Table 58. Master File Type Values
Entity Affected	Field Name	Value List Description
Registrations	Master File Type Name	The type of master file indicated for the registrations.

Table 59. Medicinal Product Name Part Type Values
Entity Affected	Field Name	Value List Description
Registrations	Medicinal Product Name Part Type Name	Specify the medicinal product name parts along with the language of the country and as the marketing authorisation applies in accordance with the referenced SmPC.

Table 60. Marketing Status Values
Entity Affected	Field Name	Value List Description
Registrations	Marketing Status Name	Marketing status for the medicinal products. This Data Administration list is mapped to the Marketing Status available in the SPOR RMS list.

Table 61. Marketing Status Reason Values
Entity Affected	Field Name	Value List Description
Registrations	Marketing Status Reason Name	Reason for updating the marketing status.

Table 62. Medical Product Action/Submission Status Values
Entity Affected	Field Name	Value List Description
Registrations	Status Name	Submission status of the Medicinal Product.

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Data Administration Tables Added: Ennov InSight 7.1

The following Data Administration tables, sections, or fields were added for Ennov InSight 7.1. These include the tables added to support IDMP data capture.

Data Administration Section: Product Family Maintenance

Table 1. Domain Type Values
Entity Affected	Field Name	Value List Description
Product Family	Domain Name	To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, the Domain Type Values table is introduced. The value for Domain Name can be entered in the respective field.

Table 2. EURD ID Values
Entity Affected	Field Name	Value List Description
Product Family	EURD Procedure Identifier EURD ID	To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, the EURD ID Values table is introduced. The values for EURD Procedure Identifier and EURD ID can be entered in their respective fields.

Data Administration Section: Product Maintenance

Table 3. Product Category Type Values
Entity Affected	Field Name	Value List Description
Product Family	Product Category Type Name	The classification of the medicinal products.

Table 4. Product Cross Reference Type Values
Entity Affected	Field Name	Value List Description
Product Family	Product Cross Reference Type Name	The type of medicinal product (MP) that is referenced. You can define it using a term ID.

Table 5. Dosage/Pharmaceutical Form Values
Entity Affected	Field Name	Value List Description
N/A	FDA Code EV Code RMS Term ID	The Dosage/Pharmaceutical Form Values now includes the respective new columns.

Data Administration Section: Other

Table 6. Application Submission Type Values
Entity Affected	Field Name	Value List Description
Sequences, Events	Application Submission Type Name	A marketing authorisation application. You can define it using a term ID.

Table 7. Attached Document Content Type Values
Entity Affected	Field Name	Value List Description
Attached Document	Attached Document Content Type Name	This is a new DA list that will be mapped to RMS list Product Information Document Type. Product Information Document Type is a new RMS list and will be introduced in the next upcoming release.

Table 8. Units of Measurement Values
Entity Affected	Field Name	Value List Description
Manufactured Item, PDS Packaging Detail	Units of Measurement Name	Provide the strength (quantitative composition) of the substances (including active substances, ingredients, solvents, adjuvant as applicable) in this field with a numerator and denominator value.

Data Administration Section: Application Maintenance

Table 9. Regulatory Entitlement Type Values
Entity Affected	Field Name	Value List Description
Application	Regulatory Entitlement Type	To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, the Reguatory Entitlement Type Values table is introduced. The values for Regulatory Entitlement Type can be entered in the respective fields.

Table 10. Orphan Status Values
Entity Affected	Field Name	Value List Description
Application	Orphan Status Name	Orphan status. For example: Expired, Pending, Valid, Withdrawn.

Table 11. Product Information Document Type Values
Entity Affected	Field Name	Value List Description
Application	Product Information Document Type Name	The document that contains the medicinal products details.

Data Administration Section: SPOR Master Lists

Table 12. Units of Measurement
Data Administration Table Name	Entity Affected	Field Name	Value List Description
Units of Measurement	N/A	N/A	The strength (quantitative composition) of the substances (including active substances, ingredients, solvents, adjuvant as applicable) must be specified in this field with a numerator and denominator.

Table 13. Units of Presentation
Entity Affected	Field Name	Value List Description
N/A	N/A	The strength (quantitative composition) of the substances (including active substances, ingredients, solvents, adjuvant as applicable) must be specified in this field with a numerator and denominator.

Table 14. XEVMPD Medical Devices
Data Administration Table Name	Entity Affected	Field Name	Value List Description
XEVMPD Medical Devices	N/A	N/A	Includes details of the XEVMPD Medical Devices.

Table 15. XEVMPD Medicinal Product Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the XEVMPD medicinal product type.

Table 16. Anatomical Therapeutic Chemical Classification System - Human
Entity Affected	Field Name	Value List Description
N/A	N/A	The Anatomical Therapeutic Chemical Classification System - Human table is introduced to provide the ATC code as indicated as Pharmacodynamic properties of the corresponding SmPC. As a term ID you must provide the regulatory documents.

Table 17. Country
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the medicinal product name that has been authorized as approved by the regulatory authority.

Table 18. Legal Status for the Supply
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the XEVMPD medicinal product type.

Table 19. Manufacturing Activity
Entity Affected	Field Name	Value List Description
N/A	N/A	The Anatomical Therapeutic Chemical Classification System - Human table is introduced to provide the ATC code as indicated as Pharmacodynamic properties of the corresponding SmPC. As a term ID you must provide the regulatory documents.

Table 20. Marketing Status
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the medicinal product name that has been authorized as approved by the regulatory authority.

Table 21. Master File Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Provides the status of the medicinal product supply as authorized by the relevant competent authority.

Table 22. Domain
Entity Affected	Field Name	Value List Description
N/A	N/A	Provides details of the active substance manufacturer including active substance manufacturers.

Table 23. Combination Package
Entity Affected	Field Name	Value List Description
N/A	N/A	Indicates the marketing status of medicinal products.

Table 24. Pharmaceutical Dose Form
Entity Affected	Field Name	Value List Description
N/A	N/A	Indicates the Master File used.

Table 25. Combined Pharmaceutical Dose Form
Entity Affected	Field Name	Value List Description
N/A	N/A	Helps to differentiate whether the type of medicinal product is for human or for veterinary use.

Table 26. Combined Term
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the pharmaceutical form that is submitted for authorization or is authorized by the regulatory authorities. These details are reflected in the regulatory documents.

Table 27. Medicinal Product Name Part Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the manufactured dose form described with the authorized pharmaceutical form(s). Pharmaceutical Form of the SmPC or other regulatory document.

Table 28. Packaging
Entity Affected	Field Name	Value List Description
N/A	N/A	Includes details of the combination of the two or more manufactured dose form described with the authorized pharmaceutical form(s). Pharmaceutical Form of the SmPC or other regulatory document.

Table 29. Product Category
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the combined term for medicinal products.

Table 30. Contact Party Role
Entity Affected	Field Name	Value List Description
N/A	N/A	The medicinal product name parts are specified along with the language of the country as per the marketing authorisation applies in accordance with the referenced SmPC.

Table 31. Quantity Operator
Entity Affected	Field Name	Value List Description
N/A	N/A	Details of the of the medicinal products packing.

Table 32. Routes and Methods of Administration
Entity Affected	Field Name	Value List Description
N/A	N/A	Classification of the products.

Table 33. Special Precaution for Storage
Entity Affected	Field Name	Value List Description
N/A	N/A	Type of contact in the context of the Medicinal Product that must be specified.

Table 34. Application Legal Basis
Entity Affected	Field Name	Value List Description
N/A	N/A	Indicates the strength of the substance ingredient(s) contained in the medicinal product.

Table 35. Application Submission Type
Entity Affected	Field Name	Value List Description
N/A	N/A	The method and path of drug administration.

Table 36. Regulatory Entitlement Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Indicates the precautions taken for storing and stacking drugs.

Table 37. Regulatory Entitlement Status
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the classification value of a medicinal product.

Table 38. Shelf Life Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the type of the marketing authorization application that is described using the term id.

Table 39. Product Information Document Type
Entity Affected	Field Name	Value List Description
N/A	N/A	The type of regulatory authorization.

Table 40. Material
Entity Affected	Field Name	Value List Description
N/A	N/A	The status of the marketing authorization.

Table 41. Medical Dictionary For Regulatory Activities
Entity Affected	Field Name	Value List Description
N/A	N/A	Comorbidity, intended effect and indication details used for the medicinal products.

Table 42. Product Cross Reference Type
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the Product Cross Reference Types.

Table 43. EU Regulatory Authorisation Procedure
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the regulatory procedure applied to grant or amend a marketing authorization for a Medicinal Product.

Table 44. Ingredient Role
Entity Affected	Field Name	Value List Description
N/A	N/A	Comorbidity, intended effect and indication details used for the medicinal products.

Table 45. Language
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the Product Cross Reference Types.

Table 46. Organisation (OMS)
Entity Affected	Field Name	Value List Description
N/A	N/A	Defines the regulatory procedure applied to grant or amend a marketing authorization for a Medicinal Product.

Table 47. Data Classification
Entity Affected	Field Name	Value List Description
N/A	N/A	Role of the active ingredient as part of the manufactured item/pharmaceutical product.

Data Administration Section: Product Detail Set Maintenance

Table 48. Device - Type of Combination Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Device - Type of Combination Name	This value supports IDMP.

Table 49. Package Component Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Component Type Product Material	This value supports IDMP.

Table 50. Component Type Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Component Type Name	This value supports IDMP.

Table 51. Intended Effect Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Intended Effect	This value supports IDMP.

Table 52. Medical Device UDI Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Medical Device UDI Name	This Data Administration table is used to populate the Device Type field for PDS Component - Medical Devices. This Data Administration list is mapped to the Device Type value in the SPOR RMS list section.

Table 53. Manufacturing Function Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Component Type Name	This value supports IDMP.

Table 54. Data Classification Type Values
Entity Affected	Field Name	Value List Description
Product Detail Set	Data Classification Type Name	This Data Administration table is used to populate the Confidentiality Indicator field on the Data Administration Manufacturer Values - Data Administration Manufacturer Values > Global Product Details > Global Detail Sets.

Data Administration Section: Registration Maintenance

Table 55. Content of Change Values
Entity Affected	Field Name	Value List Description
Registrations	Content of Change Name	This Content of Change provided for the IDMP attachment.

Table 56. Data Carrier Type Values
Entity Affected	Field Name	Value List Description
Registrations	Data Carrier Type Name	This table is used to display the value for the Data Carrier Type field for the Registration Package Set Country.

Table 57. Provenance Reason Values
Entity Affected	Field Name	Value List Description
Registrations	Provenance Reason Name	The reason of the activity of medicinal product data submission in the Postmarketing surveillance (PMS).

Table 58. Master File Type Values
Entity Affected	Field Name	Value List Description
Registrations	Master File Type Name	The type of master file indicated for the registrations.

Table 59. Medicinal Product Name Part Type Values
Entity Affected	Field Name	Value List Description
Registrations	Medicinal Product Name Part Type Name	Specify the medicinal product name parts along with the language of the country and as the marketing authorisation applies in accordance with the referenced SmPC.

Table 60. Marketing Status Values
Entity Affected	Field Name	Value List Description
Registrations	Provenance Reason Name	The reason of the activity of medicinal product data submission in the Postmarketing surveillance (PMS).

Table 61. Marketing Status Reason Values
Entity Affected	Field Name	Value List Description
Registrations	Master File Type Name	The type of master file indicated for the registrations.

Table 62. Medical Product Action/Submission Status Values
Entity Affected	Field Name	Value List Description
Registrations	Medicinal Product Name Part Type Name	Specify the medicinal product name parts along with the language of the country and as the marketing authorisation applies in accordance with the referenced SmPC.