Product Family Maintenance

Product family values appear in lists on the Product Family Attributes page and are designated at the time a product family is created or modified.

Data Administration enables you to add or modify list values, and set the status of a value to active or inactive. When you select a value under Product Family Maintenance, a table of all values that have been defined appears. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.

Note: The proper data administration access privileges are required to view and modify product family maintenance values.

All XEVMPD Data Administration tables provide the ability to configure extra fields. The standard set consists of twenty extra text fields, five extra date fields, and five extra number fields.

Product Family Maintenance: Product Family Values

You can create and maintain the following product family values:


Value	Description
ATC	EU-specific Pharma Anatomical Therapeutic Chemical class code. The list contains ATC codes from the EMA ATC Code Additions CV. The default value is set to Active. The standard set of extra fields can be configured for this value.
Division Values	Related to the Office of Device Evaluation (ODE) Review Divisions, for example, Division of Cardiovascular, Respiratory and Neurological Devices, Division of Clinical Laboratory Devices, etc.
Domain Type Values	Indicates whether the type of medicinal product is for human or for veterinary use.
EURD ID Values	When the medicinal product is part of a PSUR single assessment procedure in accordance with the European Union reference date dates and frequency of submission of periodic safety reports list (EURD list), the EURD ID shall be provided. The EURD ID shall be derived from the procedure number of the PSUR single assessment, which is published in the EURD list Excel file available on the 'Periodic safety update reports' webpage.
Product Family Status	The status of the product family, such as investigational, planned, approved, active, withdrawn.
Product Family	The highest level of a product defined by the company-based user-defined product family code and/or name.
Substance Class	Classification given to substances. Examples are mixture, and specified substance classes. The list contains substance classes and substance class code from the EMA Substance Class CV. The default value is set to Active. The standard set of extra fields can be configured for this value.
Substance Subtype Type Values	Subtypes of substance. The following values pre-populate in the grid. You cannot activate/modify the values below. For configuration assistance, contact our support representatives. — Uncategorized (inactive by default) — CMR Substance — Endocrine Substance — Strain — Human Product Substance — Placeholder — Substance
Value	Description
Substance	Defines substance values with their affiliated attributes. The XEVMPD related substance entities such as substance alias (the tab is hidden), substance attachments, substance international codes and substance translations (the tab is hidden), substance management services can be added using the Substance option. Several types, such as Substance, Placeholder, and Strain, can be selected from the list. The default type value is Substance. The list contains the substances from the EMA Substances CV. The default value is set to Inactive. The standard set of extra fields can be configured for this value.
Therapeutic Area	Therapeutic use, such as oncology, cardio-renal, pulmonary. The standard set of extra fields can be configured for this value.
Therapeutic Class	Groups of similar drugs used to treat a specific condition. The standard set of extra fields can be configured for this value.
Trade Name	The name under which a company markets a drug.

ATC Attributes To define an ATC value, enter values for the following attributes:


Attribute	Description
ATC Code	Standard Code defined by the EMEA used to identify Anatomical Therapeutic Chemicals (ATC). ATC is a classification system for drug substances which is maintained by the WHO Division of Drug Management and Policies (DMP).
ATC Description	Name of the Anatomic Therapeutic Class assigned by the EMEA.
Term Type	Type of ATC term. Examples: Development Term, Proposed Term, Standard Term
ATC Level	Level of the ATC Code. The field can be used to track the level of the ATC.
Version Date	Only needed for dev and proposed terms for XEVMPD.
Development Type Acknowledged	This field is needed for the application. It is not specified by the EMA. Values available for selection: Yes/No. Default is No
Proposed Type Acknowledged	This field is needed for the application. It is not specified by the EMA. Values available for selection: Yes/No. Default is No
Date Submitted to EMA	Date Submitted to EMA populated automatically when Acknowledgment Wizard passed.
Last Updated Date	Last Updated Date populated automatically when updates were made to the table.
RMS Term Name	List of ATC RMS Values available for selection.
Attribute	Description
Comments	Comments associated with the ATC.
XEVMPD Comments	Comment field.
Last User Updated	Indicates the name of the user who last created/updated the ATC values. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Division Attributes

To define a division value, enter values for the following attributes:


Attribute	Description
Division	Relates to the Office of Device Evaluation (ODE) Review Divisions. Examples: Division of Cardiovascular, Respiratory and Neurological Devices; Division of Clinical Laboratory Devices; Division of Dental, Infection Control and General Hospital Devices; Division of General and Restorative Devices; Division of Opthalmic Devices; Division of Reproductive, Abdominal, Ear, Nose and Throat Radiological Devices
Default Flag	Flag to indicate if the product status is the default.Yes and No values are available for selection.
Last User Updated	Indicates the name of the user who last created/updated the division value. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is readonly. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Domain Type Attributes

To define a domain value, enter values for the following attributes:


Attribute	Description
Domain Name	Indicates whether the type of medicinal product is for human or for veterinary use.
Last User Updated	Indicates the name of the user who last created/updated the domain type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Attribute	Description
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

EURD ID Attributes

To define an EURD ID value, enter values for the following attributes:


Attribute	Description
Family Identifier/ Active Substances	Indicates the Family Identifier.
EURD ID	The EURD ID is derived from the procedure number of the PSUR single assessment which is published in the EURD list Excel file available on the Periodic safety update reports web page.
Last User Updated	Indicates the name of the user who last created/updated the EURD ID value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Family Status Attributes

To define a product family status value, enter values for the following attributes:


Attribute	Description
Name	The name given for the Product Family Status.
Default Flag	Flag to indicate if the product status is the default.Yes and No values are available for selection.
Last User Updated	Indicates the name of the user who last created/updated the product family status. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Family Attributes

To define a product family value, enter values for the following attributes:


Attribute	Description
Product Family Type	Type of Product Family. Examples: Pharmaceutical, Flu Vacine, Veterinary, Medical Devices, Pharma-Med Device
Family Code	Code of Product Family.
Family Name	Name of Product Family.
Product Family Status	Status of Product Family. Example: Active, Planned.
	*Note:* By default, the field is hidden.

Product Family Status Date	Status Date of Product Family.
	*Note:* By default, the field is hidden.

Development Sponsor	Development Sponsor value in following concatenation MAH/Development Sponsor/Organisation Name + Address + City + Country Code.
	*Note:* By default, the field is hidden.

Last User Updated	Indicates the name of the user who last created/updated the product family. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Substance Class Attributes To define a substance class value, enter values for the following attributes:


Attribute	Description
Substance Class Name	Classification given to a substance. Examples: Mixture, Single, Specified Substance (must be specified for an Insert or Update operation)
Substance Class Code	Code assigned to the substance class.
Last User Updated	Indicates the name of the user who last created/updated the substance class. By default, this option is read-only. It is populated automatically when updates were made to the table.
Attribute	Description
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Substance Subtype Attributes

To define a substance value, enter values for the following attributes:


Attribute	Description
Name	A unique name for the substance subtype value.
Last User Updated	Indicates the name of the user who last created/updated the substance. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Substance Attributes

To define a substance value, enter values for the following attributes:


Attribute	Description
Type	Defines the type of each Substance value. The values available are: — Uncategorized (inactive by default) — CMR Substance — Endocrine Substance — Strain — Human Product Substance — Placeholder — Substance
Substance Name	Name of the Substance. Combination of Substance Type + Substance Name should unique in the system.
Category of CMR Type	Indicates the CMR Substance categories. This field appears only when you select the CMR Substance value in the Type field.
INN	International Non-proprietary name.
CAS Number	Chemical Abstract Services number assigned to the Substance.
Molecular Formula	Chemical formula of the substance.
Attribute	Description
Compound Number	The compound number of substance, if exists.
XEVMPD Development Substance	Identifies the substance as a Development Substance.
Substance Level Class	All active Substance Level Class Values from Data Administration.
CBD	Chemical Biological Description of the Substance.
Development Sponsor	Sponsor of the Clinical Trials if this is a Development Substance. Required by XEVMPD if this is a Development Substance in following concatenation MAH/Development Sponsor/Organisation Name + Address + City + Country Code.
Compendial Designation/ Source	Compendial Designation/ Source. Substance Source in XEVMPD.
Keywords	Free format text box where users can enter text for searching purposes.
Description	Free format text box for entering descriptive information.
Comments	Free format text box where users can enter information.
Last User Updated	Indicates the name of the user who last created/updated the substance. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Therapeutic Area Attributes To define a therapeutic area value, enter values for the following attributes:


Attribute	Description
Therapeutic Area Name	Full Therapeutic Area Name. Example: Oncology, Anti-Inflammatory.
Last User Updated	Indicates the name of the user who last created/updated the therapeutic area. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Therapeutic Class Attributes

To define a therapeutic class value, enter values for the following attributes:


Attribute	Description
Therapeutic Class	Full Therapeutic Class Name. Example: Oncology, Anti-Inflammatory
Therapeutic Class Code	Code used to define Therapeutic Class.
Last User Updated	Indicates the name of the user who last created/updated the therapeutic class values. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Trade Name Attributes

To define a trade name value, enter values for the following attributes:


Attribute	Description
Trade Name	The trade name given.
Last User Updated	Indicates the name of the user who last created/updated the trade name. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Substance Subtype Attributes

To define a substance subtype value, enter values for the following attributes:


Attribute	Description
Name	Indicates a unique substance subtype name.
Last User Updated	Indicates the name of the user who last created/updated the division value. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Substance Entity Values

Use different tabs on the Substance Values page to add or modify additional substance data.

Ennov InSight enables you to add or modify values for Substance entities such as: Substance XEVMPD Information, Substance Alias, Substance Attachments, Substance International Codes, Substance Translations and SMS (Substance Management Services).

You can:

— Create a new Substance Value and add entity values for it. — Add entity values for an existing Substance Value.

Note: The Substance Aliases and Substance Translations tabs can be hidden or made visible via overrides on the Substance Values page.

Add Substance Entity Values

To add substance entity values:

Choose Go To > Data Administration.
Under Product Family Maintenance, click Substance Values.
Click the link corresponding to the substance value.
Select the tab corresponding to the substance entity to which you want to enter the values.
Click the Create icon .
Enter the values and click Save.
Repeat steps 4 through 6 to add values for different substance entities.

Modify Substance Entity Values via Entity Name

Ennov InSight enables you to modify values for Substance entities such as: Substance XEVMPD Information, Substance Alias, Substance International Codes, and Substance Translations via entity name.

You also can modify substance entity values by clicking on the entity name:

Choose Go To > Data Administration.
Under Product Family Maintenance, click Substance Values.
Click the link for the substance you want to modify.
Select the tab corresponding to the substance entity for which you want to modify the values.
Click on the name of the entity.
The entity attributes page opens.
Enter the information and click Save.
Repeat steps 4 through 6 to modify values for different substance entities.

Note: The Substance Aliases and Substance Translations tabs can be hidden or made visible via overrides on the Substance Values page.

Mass Activating or Deactivating Substance Entities

Ennov InSight enables you to activate or deactivate all the entities of a substance value using a single operation.

The entities of a substance such as the Substance Alias (the tab is hidden), Substance Attachments, Substance International Codes, and Substance Translations(the tab is hidden), can be activated or deactivated by activating or deactivating the substance.

To activate or deactivate substance entities:

Choose Go To > Data Administration.
Under Substance Values, click the link for the value you want to activate/deactivate.
Click the Edit icon.
Do one of the following:


Option	Action
To activate the substance and its entities	Select Activate.
To deactivate the substance and its entities	Select Deactivate.

The activation process can be performed for the whole Substance entity only, and all its sub tabs will be activated automatically. You can deactivate either the whole Substance entity, or deactivate separately all Substance sub tabs, such as the Substance Alias, Substance Attachments, Substance International Codes, and Substance Translations.