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.
  1. 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.
  2. 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 :

  • 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 High Limit Numerator Value

Presentation High Limit Unit of Measurement

Presentation High Limit Unit of Presentation

Concentration

Strength

a concatenation of :

  • IDMP 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