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. |
| Attribute | Description |
|
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 Note: Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Country drop-down field on the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. |
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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/Reg istration 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. |
| Attribute | Description |
|
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. |
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MAH/Or ganisation |
The company to which a license is issued to market the product. |
|
MAH/Or ganisation 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. |
| Attribute | Description |
|
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. |
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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. |
