Package Set Registration Attributes
The attributes associate a registration to an application (package set 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. |
| Country | The country with which the registration is associated.
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 Note: Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the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.
|
| Enquiry Email | For package set registrations only, the e-mail address of the person or the agency registering the product. |
| Enquiry Phone Number | For package set registrations only, the phone number of the person or the agency registering the product. |
| 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. |
| Legal Basis | The legal basis for an authorisation of the product. |
| 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 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 Concerned Parties | Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses. |
| 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. |
| Medicinal Product Type | For package set registrations only, this includes all the medicinal product types. |
| Medicines Regulatory Agency | Health Authority Name for a selected country where License was issued. |
| MFL (Master File Location) | For package set registrations only, the name and address information for master file location company with EudraVigilance code and comments. |
| 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. |
| Package Sets | For Package Set Registrations Type only, this is the name of the package set associated with a registration. Sunset Clause dates are tracked per country for the package set.
If you disassociate a Package Set, the Registration displays the message: "You are about to dissociate the Package Set by doing this, respective ATC value will be deleted from the Registered ATC field automatically. Select Ok to continue." |
| Perpetual License | Indicates whether a perpetual license has been granted in the European Union. |
| Pricing Approved | Indicates whether pricing approval has been given. This is by default hidden for package set registrations and product registrations. |
| QPPV | For package set registrations only, the EV registration system QPPV (Qualified Person Responsible for Pharmacovigilance) code assigned to the QPPV defined in the pharmacovigilance system master file for the product. |
| Reason for Termination/Withdrawal | The reason that the package set registration was terminated or withdrawn. |
| Registered ATC | For package set registrations only, the anatomical therapeutic chemicals that are registered.
The values are available for selection only after you select the Package Sets. |
| Registered ATC Last Updated | Date on which the Registered ATC was added. |
| Reimbursement Approval | For product type registrations only, this indicates whether reimbursement approval has been given. |
| Sender Local Code | For package set registrations only, the local code of the person registering the product. |
| Subject to additional monitoring | For package set registrations only, this indicates whether the product requires close monitoring. |