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); it may 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 Note: Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the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. |
| Expiration Date/Registration Valid Until | The date the registration is due to expire. |
| Family Code | Code assigned to the product family with which the application is associated. |
| Family Name | Name of the product family that is associated with the application. |
| 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 entered by users; 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 given 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. |
| Perpeptual 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 | The anatomical therapeutic chemicals that are registered.
Note: 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. |