To associate a reference substance:
- On the Substances tab, click a link for the substance to which you want to associate a reference substance.
- Click the Reference Substances tab.
- Click Create.
- Enter values for the reference substance attributes.
- Save.
Reference Substance Attributes
The following table lists the attributes for the reference substance. The attributes that are available to you depend on your security privileges.
| Attribute | Component 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 Reference Substance Attributes for Manufactured Item only. |
| Pharmaceutical 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 Reference Substance Attributes for Pharmaceutical Product only. |
| Attribute | Component 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. |
| Reference Substance Name | P, PMD, Vet, FV | The name of the reference substance. |
| Substance Name | P, PMD, Vet, FV | The name of substance. |
| Substance Type | P, PMD, Vet, FV | The substance type. |
Table 7: 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. |
| Attribute | Component Type | Description |
| 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 8: 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 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. |
|
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 : — IDMP Concentration Measure Type — Presentation Single or Low Limit Numerator Value:
— Presentation High Limit Numerator Value
|
| Concentration Strength |
a concatenation of : — IDMP Concentration Measure Type — Concentration Single or Low Limit Numerator Value: |
— Concentration Single or Low Limit Denominator Value
— Concentration High Limit Numerator Value
— Concentration High Limit Denominator Value
|
Modify a Reference Substance
Modify the attributes of the reference substance to include the necessary values.
To modify a reference substance:
- On the Reference Substances tab, click the link for the reference substance that you want to modify.
- On the Reference Substance Attributes page, click Modify.
- Make the necessary changes.
- Save.
Delete a Reference Substance
You can delete a reference substance that is not required for an entity.
To delete a Reference Substance:
- On the Reference Substances tab, click the link of the reference substance that you want to delete.
- On the Reference Substance Attributes page, click Delete.
- On the confirmation message, click OK.
