Pharmaceutical Product

The Pharmaceutical Product entity is required by the European Medicines Agency (EMA) for XEVMPD schema support. Ennov InSight enables you to view, create, modify, and delete the Pharmaceutical Product.

You must have at least READ permissions for Product Detail Management (PDM), Registration Planning and Tracking (RPT) licenses, and Product Entity Security to view Pharmaceutical Product.

You can also add notifications on the Notification tab. Notifications associated with the Pharmaceutical Product display only if you have at least WRITE privileges for the Notifications.

Note: The Pharmaceutical Product reports that you see on the Querying tab refer to Product of Pharmaceutical type, and are not for a Pharmaceutical Product entity.

Create a Pharmaceutical Product

Ennov InSight enables you to create a Pharmaceutical Product for a Product, which contains one or more components.

You must have at least Write privileges for Product Detail Management (PDM), Registration Planning and Tracking (RPT) licenses, and Product Entity Security to create the Pharmaceutical Product entity.

To create a Pharmaceutical Product:

Create a Product and a one or more Components for it.
On the Product Attributes page select the Pharmaceutical Products tab.
Click Create Pharmaceutical Product.
The Create Pharmaceutical Product page opens.
Enter the needed properties and click Save to save the data. To cancel the action, Cancel.

Note: You can create a Pharmaceutical Product under all Product Family types except Medical Devices.

If Pharmaceutical Product required properties are not populated with valid data, a message is displayed and the entity is not created. The required fields are the Pharmaceutical Product Name and Components. Other fields are optional.

Product Family Type, Family Code, Family Name, and Product Name are already populated by the system in display mode.

Pharmaceutical Product Attributes

The Pharmaceutical Product entity is required by the European Medicines Agency (EMA) for XEVMPD schema support.

The following attributes describe the specific Pharmaceutical Product under the Product.


Attribute	Description
Family Type	The type of products associated with this product family (for example: pharmaceutical, medical device).
Family Code	The company-specific code for the product family.
Family Name	The standard name recognized internally and across countries.
Attribute	Description
Product Name	The standard product name recognized internally and across countries. On some pages, 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.
Pharmaceutical Product Name	The standard pharmaceutical product name recognized internally and across countries. The product name must be unique.


Pharmaceutical Product Summary	The value in the field is displayed as a concatenation of the values: — First line: Administrable Dose Form + Route of Administration divided by space. — Second Line: List of Active Ingredient Name values (or Reference Active Ingredient if specified) + Unit of Presentation + Strength, divided by comma. Active Ingredients are in the alphabetical order If a reference active ingredient is defined, no corresponding active ingredients are in the list. If there are no pharmaceutical active ingredients, the component active ingredients show. The strength values Equal to and Range do not show in the Pharmaceutical Product Summary field. The Strength is defined by IDMP presentation values, if not specified, IDMP concentration values are taken. Otherwise, XEVMPD strength values are present. Otherwise, an active ingredient name with empty strength value. — If the Pharmaceutical Product Description and Unit of Presentation values are empty, no third line is available. By default, the field is hidden.
Medical Device	Describes the code of a medical device where it forms an integral part of the medicinal product.
Components	The parts that build the final product. Selected list includes selected Components for the Pharmaceutical Product.
Administrable Dose Form	The physical form in which this product is administered.
Product Quantity Value	The quantity (or count number) of the pharmaceutical product. By default, the field is hidden.
Product Quantity Unit	The quantity (or count number) of the pharmaceutical product. By default, the field is hidden.
Attribute	Description
Unit of Presentation	The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate.
Product Characteristics	The individual value from the code system that describes the actual characteristic. By default, the field is hidden.
Pharmaceutical Product Concerned Parties	Contains email addresses and User Ids for which Notifications can be sent. Concerned parties are anyone who may be copied on notifications about this entity; use semi-colons (;) to separate e-mail addresses
Pharmaceutical Product Keywords	Words you can use to search for the Pharmaceutical Product.
Pharmaceutical Product Description	Text that describes the Pharmaceutical Product.
Pharmaceutical Product Comments	The discussion thread that includes all comments entered by users; includes the date and time the comments were entered and the user ID of the person who entered them.
	Comments you want to share with others in a discussion thread. Will be displayed in
Pharmaceutical Product Add Comment	the Pharmaceutical Product Comments box, stamped with the date and time you enter the information and your user ID.
	*Note:* The Pharmaceutical Product Add Comment field is available on the Create/Modify Pharmaceutical Product Attributes pages only.

Route of Administration	Defines how this product is introduced into the system, such as oral, and intravenous. Route of Administration is dependent on Dosage Form - this may be defined at either the product level or at the individual component level or both.

Modify a Pharmaceutical Product

You can modify a previously created Pharmaceutical Product to change the existing data.

You should have at least WRITE privileges for Product Detail Management (PDM), Registration Planning and Tracking (RPT) licenses, and Product Entity Security to modify the Pharmaceutical Product entity.

To modify the Pharmaceutical Product:

On the Pharmaceutical Product tab, select the Pharmaceutical Product entity you want to modify.
Click Modify.
On the Modify Pharmaceutical Product page, modify the attributes and Save. To cancel your changes, click

Cancel.

If Pharmaceutical Product required properties are not populated with valid data, a message appears and the entity is not modified.

Note: You can modify the Pharmaceutical Product until it is not associated to the Application.

The Pharmaceutical Product View displays the updates.

Delete a Pharmaceutical Product

You can delete a previously created Pharmaceutical Product entity data from the system.

At least Write privileges for Product Detail Management (PDM), Registration Planning and Tracking (RPT) licenses, and Product Entity Security are required to delete the Pharmaceutical Product entity.

To delete the Pharmaceutical Product:

On the Pharmaceutical Product tab, select the Full Pharmaceutical Product entity you want to delete.
Delete .
A warning message appears, click OK.
On the message confirming that the data has been deleted, click OK.

The Product Attributes page opens. The Pharmaceutical Product is deleted and no longer displays in any Pharmaceutical Product value lists.

PhPIDs

The Pharmaceutical Product Identifier (PhPID) enables you to uniquely associate medical products with the same or similar pharmaceutical composition based on data elements and structures for unique identification and exchange of regulated pharmaceutical product information.

The PhPID entity is required by the Identification of Medicinal Product (IDMP) data standards to maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data. Ennov InSight enables you to view, create, modify, and delete the PhPIDs.

You must have at least Read permissions for Product Detail Management (PDM), Registration Planning and Tracking (RPT) licenses, and Product Entity Security to view Pharmaceutical Product and PhPID.

Create a PhPID

Use PhPID for unique identification and exchange of regulated pharmaceutical product information.