Country Specific Detail

The Country Specific Detail entity is required by the European Medicines Agency (EMA) for XEVMPD schema support.

You must have at least READ permissions for Product Detail Management (PDM), Registration Planning and Tracking (RPT) licenses, and Product Entity Security to view Country Specific Detail. Ennov InSight enables you to view, create, modify, and delete the Country Specific Detail.

You can:

— View Country Specific Detail - View a previously created or modified entity.

— Create Country Specific Detail - Create the new Country Specific Detail entity.

— Modify Country Specific Detail - Change the previously created entity data.

— Delete Country Specific Detail - Remove the previously created data from the system.

The following actions can be performed from the Country Specific Detail attributes page:

Country Specific Details are applicable for a Product that belongs to a Family Type of Medical Devices and Pharmaceutical Medical Device.

— Modify

— Delete

Create a Country Specific Detail

Ennov InSight enables you to create a Country Specific Detail for a Medical Device 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 Country Specific Detail entity.

To create a Country Specific Detail:

  1. Create a Product and a one or more Components for it.
  2. On the Product Attributes page, select Country Specific Details.
  3. Click Create Country Specific Detail.

    The Create Country Specific Detail page opens.

  4. Enter the needed properties and Save.

To cancel the action, Cancel.

If the Country Specific Detail required property is not populated with valid data, a message is displayed and the entity is not created. The required field is the Country Specific Detail Type field. Other fields are optional.

Modify a Country Specific Detail

You can modify a previously created Country Specific Detail 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 Country Specific Detail:

  1. On the Country Specific Details tab, select the Country Specific Detail entity you want to modify.

    The Country Specific Detail Attributes page is displayed.

  2. Click Modify.
  3. On the Modify Country Specific Detail Attributes page, modify the attributes and Save. To cancel your changes, click Cancel.

If Country Specific Detail required properties are not populated with valid data, a message appears and the entity is not modified.

The Country Specific Detail view displays the updates.

Delete a Country Specific Detail

You can delete a previously created Country Specific Detail 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 Country Specific Detail:

  1. On the Country Specific Details tab, select the Country Specific Detail entity you want to delete.
  2. Delete.
  3. A warning message appears, click OK.
  4. On the message confirming that the data has been deleted, click OK.

The Product Attributes page opens. The Country Specific Detail is deleted and no longer displays in any Country Specific Details list.