Ennov InSight Registrations 7.2

Product Registration Attributes

The attributes associate a registration to an application (of product registration type), and provide details of the registration.

Attribute Description
Annual Report Date The date that the next annual report for this registration is due.
Application Code Agency-identified application number (or identifier). Can be the same as the internal code.
Application Name The name of the application.
Associated Products Products available for selection are those currently associated with the Event.
Country The country that is associated with the registration.

For registrations of the Centralised Procedure (CP) procedure type, European Union is the only country available for selection.

Note: Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Country drop-down field on the Create Registration page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types.
Currently Marketed Indicates whether the product is actually being sold.
Event The Event Name and Event Code are concatenated and displayed for selection.

If you disassociate the Event/Product(s), the system displays the message: "You are about to dissociate the Event/Product(s) by doing this, respective ATC value will be deleted from the Registered ATC field automatically. Select Ok to continue."

Expiration Date/Registration Valid Until The date the registration is due to expire.
In-Licensing Text that indicates whether the license is considered an in-license.
Last Renewal Date The date when the license was last renewed.
License Add Comments Comments you want to share with others in a discussion thread. Will be displayed in the License Comments box, stamped with the date and time you enter the information and your user ID.
Note: The License Add Comment field is available on the Create/Modify Registration Attributes pages only.
License Code The code assigned by the regulatory agency.
License Concerned Parties Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses.
License Comments The discussion thread that includes all comments. Includes the date and time the comments were entered and the user ID of the person who entered them.
License Description Text that describes the registration.
License Issue Date The date when the license is to be issued.
License Keywords Words you can use to search for the registration.
License Status The current renewal status.
License Status Date The effective date of the status.
MAH/Organisation The company to which a license is issued to market the product.
MAH/Organisation Last Updated The date that the MAH was most recently updated.
Medicines Regulatory Agency Health Authority Name for a selected country where License was issued.
Next Renewal Date The date when the license must be renewed again
Out-Licensing Text that indicates whether the license is considered an in-license.
Perpetual License Indicates whether a perpetual license has been granted in the European Union.
Product Family Type The type of product family that is associated with the registration.
Reason Reason for creating, modifying or deleting a registration.
Reason for Comments Comments related to reason entered by users.
Reason for Termination/Withdrawal The reason that the product registration was terminated or withdrawn.
Registered ATC Registered anatomical therapeutic chemicals.

If an application is associated to a product family, the values from the product family are available for selection. Otherwise, the values are taken from the associated application product.

Note: Appears for all product family types except medical devices.
Registered ATC Last Updated Date on which the Registered ATC was added.
Subject to Additional Monitoring This indicates whether the product requires close monitoring.
User ID The user name to validate user identity.
Password The user password to validate user identity.