Ennov InSight Registrations 7.2

Application Attributes

The attributes values that appear on the page depend on:
  • How you create the application.
  • If you are creating a National, Centralised Procedure (CP), Decentralised Procedure (DCP), or Mutual Recognition (MRP) application.
  • If you are creating a Clinical Trial Authorization (CTA), Clinical Trial Regulation (CTR) or Investigational New Drug (IND) application or another type of application.

Use the following descriptions to help you choose and modify attribute values.

Attribute Description
Actual Approval Date When the application is first approved.
Actual Launch Date Actual date of the product launch.
Actual Submission Date When the application is submitted.
Annual Report Date The date when the next annual report is due. This attribute is only for a CTA and CTR application.
Applicant ID Identity of the entity that submits the application to regulatory authorities.
Application Add Comment Comments you want to share with others in a discussion thread. Stamped with the date and time that you enter the information and your user ID.
Application Code Agency-identified application number (or identifier). Possibly unknown until submittal time. For this reason, it can be the same as the internal code.
Application Comments The discussion thread that includes all comments entered by users. Includes the date and time the comments were entered and the user IDs of those who entered them. Comments appear on the Modify Application Attributes page.
Application Concerned Parties Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses.
Application Description Text that describes the application.
Application Keywords Words that you can use to search for the application.
Application Name The name of the application.
Application Owner The person responsible for creating the application.
Application Prefix The prefix of the application.
Application Status The status of the application.
Note: The Application Status can be set to Withdrawn only when all Registrations associated to this Application have a status mapped to internal WITHDRAWN status.
Application Status Date The date when the current status was set.
Application Type The type of application that you are creating. The application types that you can choose from are dependent on the reviewing country. The attributes displayed vary by the application type selected:
  • CTA, CTR, and IND application types have different attributes than all other application types.
  • You cannot modify the application type in Ennov InSight after creating the application.
Arbitration For CP, DCP, and MRP procedure type applications, indicates if the application has been in arbitration.
Associated Products The products to associate with the application. Available for RPT-licensed users only.
Clinical Trials # The number used to identify the clinical trials assigned to the application.
Co-Rapporteur For a CP application, the co-rapporteur associated with an application.
Countries

MRP/CP/Herbal/Homeopathic countries.

When creating a new application, if the application procedure type is MRP, CP, Herbal or Homeopathic, you can add countries to the application as Concerned Member States (CMS).

For CP procedure type applications, in addition to the individual countries that you add as CMS, you must also add the European Union to the application as a CMS.

Dossier Language The language in which supporting documentation is written.
Family Names The application-related product family names.
  • If application has products from different product families, the hyperlinked comma-separated values for product families are displayed.
  • For application without products created from the wizard, no values are displayed in the field.
IMPID Investigational Medicinal Product Identifier for CTA, CTR and IND applications.
Last Role Change Date When the country's role for the application date last changed.
Legal Basis The legal basis for the authorization of the product.
Legal Status of Supply How the product is approved to be sold. Might be unavailable for ELP users.
Local PSUR Date The date that the periodic safety report is due for this application.
Local PSUR Data Lock Date The date up to which information must be compiled for the periodic safety report for this application.
Next Renewal Date Date of the next renewal.
Orphan Drug Indicates whether the drug treats a rare disease affecting less than 200,000 people in the reviewing country.
Orphan Drug Last Updated The date on which the Orphan Drug attribute was last updated. This attribute is only for an IND application.
Planned Approval Date When the application is to be approved for the first time.
Planned Launch Date Expected date for the launch of the product.
Planned Submission Date When the application is to be submitted for the first time.
Procedure Date End The date when the procedure was completed. For National, MRP, DCP and CP applications.
Procedure Date Start The date when the procedure commenced. For National, MRP, DCP and CP applications.
Procedure Identifier The unique identifier for the specific instance of a procedure undertaken. For National, MRP, DCP and CP applications.
Procedure Type Defines the strategy used when applying for market approval: National, CP, DCP or MRP.
Note: Procedure Start Date, Procedure End Date, Procedure Identifier will appear if you select MRP, CP, DCP or National Procedure Type for any Application type, except CTA, CTR and IND.
Product Family Type The type of products associated with this product family, for example, pharmaceutical, medical device.
Reason Reason for creating, modifying, or deleting an application.
Reason for Comments Comments related to reason entered by users.
Reason for Not Approving The reason that the application was not approved. This attribute is only for CTA and CTR applications.
Reason for Premature Ending The reason that the application ended prematurely. This attribute is only for CTA and CTR applications.
Reason for Termination/Withdrawal The reason that the application was terminated or withdrawn.
Region(s) The region of the world that is associated with the reviewing country. Provided automatically. The value displayed is a comma-separated list that includes Region Type-Region pairs for the selected Reviewing Country. The list is alphabetical by region type.
Registration Type When you create a registration, you associate it with an application. This attribute specifies whether the registrations you associate with the application will be of a registration type that is mapped to an internal value of either package set or product.
Note: This attribute can be configured to default to one registration type and be non-editable.
Related Applications Any applications to which the new application is related.
Reviewing Country Primary country reviewing the application. For a CP application, this is the rapporteur. For an MRP or DCP application, this is the reference member state (RMS). For all other applications, it is the national country.

The page refreshes to display the appropriate attributes for the country you choose.

Reporting Member State Primary country reviewing the application. For a CP application, this is the rapporteur. For an MRP or DCP application, this is the reference member state (RMS). For all other applications, it is the national country.

The page refreshes to display the appropriate attributes for the country you choose.

This attribute is only for CTR applications.
Sponsor The individual, company, institution, or organization that takes responsibility for the Clinical Trial's initiation, management, and/or financing. Values for this come from the MAH/Sponsor/Legal Representative list. This is an attribute only for CTA and CTR applications. The value is presented in concatenation of MAH/Development Sponsor/Organization Name, Address, City and Country Code.
Starting Sequence Number The number of the first sequence in the application, used if special permission by the agency allows starting on a sequence number other than 0000.
Study Number Identifier for the study for which the CTA or CTR is created. This attribute is only for CTA or CTR applications.
Termination/Withdraw Date The date when the application is terminated or withdrawn. Cannot be greater than today's date plus one day.
UUID UUID is a universal unique identifier that is automatically generated by the system. This field is visible and available for modification only for countries that belong to the European Union or Undefined region.
  • In the Application entity, the value can be modified only by users with Administrator permissions to the application, based on Application/Country rights.
  • Through the eCTD wizard, users with appropriate permissions are able to modify the UUID to support Sequences that may require a different UUID than the remainder of the Application. In most cases, the UUID value should not change.
Note: The UUID should contain 32 digits separated by 4 hyphens (xxxxxxxx-xxxx-xxxx-xxxx-xxxxxxxxxxxx).