Ennov InSight Registrations 7.2

Reference Active Ingredient Attributes

Use the following descriptions of reference active ingredient attributes to enter attribute values when creating or modifying a reference active ingredient. The attributes that are displayed depend on your security privileges.

Attribute Component Type Description
Active Ingredient Name P, PMD, Vet, FV The name of the active ingredient. Drop-down list.
Component Name P, PMD, Vet, FV The component that contains the active ingredient with reference active ingredient. This filed is available for Active Ingredient Attributes for Component only.
Concentration Measure Type P, PMD, Vet Used with other attributes to specify information about the concentration of the reference active ingredient. Values: Equal, Range, Up to, or Not Less Than. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
Exclude from IDMP Submission P, PMD, Vet, FV Indicates the presence or absence in IDMP Submission. Yes or No values. This field is available for Reference Active Ingredient Attributes for Pharmaceutical Product only.
Use for xEVMPD P, PMD, Vet, FV Indicates if Reference Active Ingredient is used for xEVMPD. Yes or No values. This field is available for Reference Active Ingredient Attributes for Pharmaceutical Product only and is added to the XEVMPD Submission Wizard logic to take into consideration only that Pharmaceutical Product Reference Active Ingredient which has a field value as a Yes.
Family Code P, PMD, Vet, FV The company-specific code for the product family that is associated with the reference active ingredient.
Family Name P, PMD, Vet, FV The product family that is associated with the active ingredient.
Family Type P, PMD, Vet, FV The type of products in the product family that are associated with the reference active ingredient. For example, pharmaceutical, medical, or device.
High Amount Denominator Prefix P, PMD, Vet The high limit amount denominator value. Must only be specified when a Range is described. Must be a Value from the published list. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
High Amount Denominator Unit P, PMD, Vet The high limit amount denominator unit. Must only be specified when a Range is described. Must be  a Value from the published list. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
High Amount Denominator Value P, PMD, Vet The high limit amount denominator value. Must only be specified when a Range is described. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
High Amount Numerator Prefix P, PMD, Vet The high limit amount numerator prefix must only be specified when a Range is described. Must be a Value from the published list. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
High Amount Numerator Unit P, PMD, Vet The high limit amount numerator unit must only be specified when a Range is described. Must be a Value from the published list. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
High Amount Numerator Value P, PMD, Vet The high limit amount numerator value. Must only be specified when a Range is described. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
Low Amount Denominator Prefix P, PMD, Vet The low limit amount denominator prefix or for non-range measurements the amount denominator prefix. Must be a Value from the published list. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
Low Amount Denominator Unit P, PMD, Vet The low limit denominator unit or for non-range measurements the amount numerator unit. Must be a Value from the published list. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
Low Amount Denominator Value P, PMD, Vet The low limit amount denominator value or for non-range measurements the amount denominator value. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
Low Amount Numerator Prefix P, PMD, Vet The low limit amount numerator prefix or for non-range measurements the amount numerator prefix. Must be a Value from the published list. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
Low Amount Numerator Unit P, PMD, Vet The low limit amount numerator unit or for non-range measurements the amount numerator unit. Must be a Value from the published list. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
Low Amount Numerator Value P, PMD, Vet The low limit amount numerator value or for non-range measurements the amount numerator value. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
Manufactured Item Name P, PMD, Vet, FV The name of manufactured item. This field is available for Reference Active Ingredient Attributes for Manufactured Item only.
Measurement Point P, PMD, Vet The physical or logical location at which a condition is described. This field is available for the Reference Active Ingredients Attributes of Component and Pharmaceutical Product only.
Product Name P, PMD, Vet, FV The product with a component and active ingredient that contains the reference active ingredient.
Pharmaceutical Product Name P, PMD, Vet, FV The standard pharmaceutical product name recognized internally and across countries. The product name must be unique. This field is available for Reference Active Ingredient Attributes for Pharmaceutical Product only.
Reference Active Ingredient Name P, PMD, Vet, FV The list with all active Substances in Data Administration.
Strength Same as Component? P, PMD, Vet, FV Indicates the strength. Yes or No values. . This field is available for Reference Active Ingredients Attributes for Pharmaceutical Product and for Manufactured Item only.
Table 1. IDMP Presentation Strength
Attribute Component Type Description
Concentration Measure Type P, PMD, Vet, FV Equates to Quantity Operator in IDMP. Refers to values per unit being defined. Example: Equal, Range, Up to, Not Less Than.
Presentation Single or Low Limit Numerator Value P, PMD, Vet The Presentation Single or Low Limit Numerator Value.
Presentation Single or Low Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
Presentation Single or Low Limit Unit of Presentation P, PMD, Vet The Unit of Presentation is available for some of the attributes. Some of the values are: Bottle, Tablet, Capsule.
Presentation High Limit Numerator Value P, PMD, Vet The Presentation High Limit Numerator Value.
Presentation High Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
Presentation High Limit Unit of Presentation P, PMD, Vet The Unit of Presentation is available for some of the attributes. Some of the values are: Bottle, Tablet, Capsule.
Table 2. IDMP Concentration Strength
Attribute Component Type Description
Concentration Measure Type P, PMD, Vet, FV Used with other attributes to specify information about the quantity operator in IDMP. Values: Equal, Range, Up to, or Not Less Than.
Concentration Single or Low Limit Numerator Value P, PMD, Vet The Concentration Single or Low Limit Numerator Value.
Concentration Single or Low Limit Unit of Measurement P, PMD, Vet The Concentration Single or Low Limit Unit of Measurement.
Concentration Single or Low Limit Denominator Value P, PMD, Vet The Concentration Single or Low Limit Denominator Value.
Concentration Single or Low Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
Concentration High Limit Numerator Value P, PMD, Vet The Concentration High Limit Numerator Value.
Concentration High Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
Concentration High Limit Denominator Value P, PMD, Vet The Concentration High Limit Denominator Value.
Concentration High Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
The attributes shown in columns below are concatenations of some fields values defined above.
Attribute Name Description
IDMP Presentation Strength A concatenation of:
  • IDMP Concentration Measure Type
  • Presentation Single or Low Limit Numerator Value:
    • Presentation Single or Low Limit Unit of Measurement
    • Presentation Single or Low Limit Unit of Presentation
  • Presentation Single or High Limit Numerator Value
    • Presentation High Limit Unit of Measurement
    • Presentation High Limit Unit of Presentation
IDMP Concentration Strength A concatenation of:
  • Concentration Measure Type
  • 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