Substance Attributes
The following attributes are used for a substance to associate it with an entity.
| Attribute |
Compo nent Type |
Description |
| Component Name |
P, PMD, Vet, FV |
Name of the component associated. |
|
Family Code |
P, PMD, Vet, FV |
The company-specific code for the product family. |
|
Family Name |
P, PMD, Vet, FV |
The standard name recognized internally and across countries. |
|
Family Type |
P, PMD, Vet, FV |
The type of products associated with this product family (For example, pharmaceutical, medical device). |
|
Manufactured Item Name |
P, PMD, Vet, FV |
The name of manufactured item. This field is available for Substance Attributes for Manufactured Item only. |
|
Pharma ceutical Product Name |
P, PMD, Vet, FV |
The standard pharmaceutical product name recognized internally and across countries. The value for the product name is unique. This filed is available for Substance Attributes for Pharmaceutical Product only. |
| Attribute |
Compo nent Type |
Description |
|
Product Name |
P, PMD, Vet, FV |
The standard product name recognized internally and across countries. In some sections of the application, the product name is shown with the product code to identify a product. For example, Origine 390 could identify a product that has the name Origine and the code 390. |
|
Strength Same as PDS Substance? |
P, PMD, Vet, FV |
Indicates if the strength is same as the PDS substance. Yes or No values. |
|
Substance Name |
P, PMD, Vet, FV |
The name of substance. |
|
Substance Type |
P, PMD, Vet, FV |
The type of substance. |
Table 5. 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. |
-
Table 1. IDMP Presentation Strength
(continued)
Attribute Compo
nent
Type
Description 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. 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 2. IDMP Concentration Strength
| Attribute |
Compo nent 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.Note: When Equal is selected, it is not displayed in the XEVMPD Strength , IDMP Presentation Strength , IDMP Concentration Strength columns on the related tabs. |
|
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 Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg. |
|
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. |
6 Table 2. IDMP Concentration Strength (continued)
| Attribute |
Compo nent Type |
Description |
| 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 |
| 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 |
|
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
◦ Concentration High Limit Unit of Measurement |
