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 |
Compo nent Type |
Description |
|
Active Ingredient Name |
P, PMD, Vet, FV |
The name of the active ingredient. Drop-down list. |
| Alternate IDMP Reference Active Ingredient |
P, PMD, Vet, FV |
The name of the alternate IDMP active reference ingredient. This field is available via overrides for Pharmaceutical Product Reference Active Ingredient attributes and Manufacturer Item Reference Active Ingredients attributes only. You cannot modify the value selection after saving. For both Pharmaceutical Product Reference Active Ingredient and Manufactured Item Reference Active Ingredient, this field can be configured as a substance selection widget with all active values from Data Administration > Substance Values, or as drop-down list with the values from the Component > Reference Active Ingredient. Note: For configuration assistance, please contact your Business Development Representative. |
| Attribute |
Compo nent Type |
Description |
|
Com ponent 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. |
|
Concen tration 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 x EVMPD |
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 Denomi nator 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. |
| Attribute |
Compo nent Type |
Description |
|
High Amount Denomi nator 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 Denomi nator 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 Numera tor 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 Numera tor 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 Numera tor 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 Denomi nator 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 Denomi nator 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 Denomi |
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. |
| Attribute |
Compo nent Type |
Description |
| nator Value | ||
|
Low Amount Numera tor 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 Numera tor 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 Numera tor 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. |
|
Pharma ceutical 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. |
| Attribute |
Compo nent Type |
Description |
|
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 3. Table 1. IDMP Presentation Strength
| Attribute |
Compo nent Type |
Description |
| Strength (Presentation) Quantity Operator |
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.Note: When Equal is selected, it is not displayed in the XEVMPD Strength , IDMP Presentation Strength , IDMP Concentration Strength columns on the related tabs. |
| Presentation Single/Low Limit - Numerator Value |
P, PMD, Vet |
The Presentation Single or Low Limit Numerator Value. |
| Presentation Single/Low Limit Numerator - Unit of Measurement |
P, PMD, Vet |
The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg. |
| DP 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 Single/Low Limit Denominator Value |
P, PMD, Vet |
The value for Presentation Single/Low Limit Denominator. |
| Presentation Single/Low Limit Denominator - Unit of Presentation/Measurement |
P, PMD, Vet |
The value from Unit of Presentation and Unit of Measurement. |
Table 3. Table 1. IDMP Presentation Strength (continued)
| Attribute |
Compo nent Type |
Description |
|
Presentation High Limit Numerator Value |
P, PMD, Vet |
The Presentation High Limit Numerator Value. |
| Presentation High Limit Numerator - Unit of Measurement |
P, PMD, Vet |
The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg. |
| DP 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. |
|
Presentation High Limit Denominator Value |
P, PMD, Vet |
The value for Presentation High Limit Denominator. |
|
Presentation High Limit Denominator - Unit of Presentation/Measurement |
P, PMD, Vet |
The value is taken from Unit of Presentation and Unit of Measurement. |
Table 4. Table 2. IDMP Concentration Strength
| Attribute |
Com ponent 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. |
Table 4. Table 2. IDMP Concentration Strength (continued)
| Attribute |
Com ponent Type |
Description |
| 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:
◦ Presentation Single or Low Limit Unit of Measurement ◦ Presentation Single or Low Limit Unit of Presentation
◦ Presentation High Limit Unit of Measurement ◦ Presentation High Limit Unit of Presentation |
|
IDMP Concentration Strength |
A concatenation of:
◦ Concentration Single or Low Limit Unit of Measurement
◦ Concentration Single or Low Limit Unit of Measurement
◦ Concentration High Limit Unit of Measurement |
| Attribute Name | Description |
|
• Concentration High Limit Denominator Value ◦ Concentration High Limit Unit of Measurement |