Ennov InSight Registrations 7.2

Package Set Registration Attributes

The following attributes are used for associating a registration to a Package Set Registration type application.
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.
ATC Code Flag The Anatomical Therapeutic Chemical (ATC) Code flag is used to indicate the status of the ATC code.
  • Not Applicable - This value is selected by default and is used when the ATC code is not applicable for the registration.
  • Applied/Not Assigned - Use this when an Applicant or Marketing Authorisation holder has applied for an ATC code but has been not assigned yet.
  • Not Applied/Not Assigned - Use this when an Applicant or Marketing Authorisation holder has not applied for ATC code.
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Note: Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Country drop-down field on the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 issued 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.
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 Registered anatomical therapeutic chemicals. For package set registrations only.

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.

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.