Calyx RIM 7.0 Publishing

Initial Application Submission Attributes

You can use the attributes to describe the details of the initial application submission.

Attribute Description
Applicant ID Identifies the entity that submits the application to regulatory authorities.
Application The Application field now shows the value as a concatenation of [Application Code + Application Name].
Application Code The agency-identified application number (or identifier). This number may not be known until the time of submission, so it may be the same as the internal code. Keep in mind the following when you enter an application code or number:
  • For US applications, the application code is always a 6-digit number.
  • For Canadian applications, the application is generally an e followed by a 6-digit number (for example, e123456).
  • For Japan the application code is generally ectd- followed by a 6-digit number (for example, ectd-123456).
  • For the EU, applications numbers are generally not available until you have filed and numbers may vary by country. It is best to enter an application number that is unique and meaningful according to the specification. Samples may include a country abbreviation or an internal drug code abbreviation or number, for example, uk-h-323-001.
Application Name The name of the application that will be associated with the submission event.
Application Type The type of application for which you are creating the submission. The list of available options depends on the Reviewing Country selected.
Associated Products Products included in the Product Family that are available to include in the application.
Co-Rapporteur Used when the Reviewing Country is a member of the European Union (EU) and the submission involves a Centralised Procedure (CP).
Countries Used when the submission involves a member of the European Union (EU) and the Procedure Type is Mutual Recognition Procedure (EU MRP) or a Decentralised Procedure (EU DCP), the Countries attribute appears and enables you to select multiple countries for the submission. When an EU country is selected, European Union is automatically included in the countries selected for the submission for CP applications.
Create Sequence Determines whether the wizard will create a sequence for the application.
Description Text that describes an entity within a submission.
Event Code The code used to identify the event.
Event Type The drop-down list displays all Active values from Data Administration > Event Maintenance > Event Type Values. The New Application value is selected by default in the Event Type field.
Timeline/Event Plan A preset plan that determines the ordered progression of primary event statuses that will apply for events created from the plan.
Timeline/Event Plan Type The type of timeline/event plan used to create or update the event. The timeline/event plan type can be procedure type, event type, or none. An event created or updated by using the procedure type of timeline/event plan has a sequence of statuses that are relevant to the procedure type selected for the event. An event created or updated by using the event type of timeline/event plan has a sequence of statuses that are relevant to the event type selected for the event. An event created or updated by specifying none for the timeline/event plan type can have any sequence of active statuses. The sequence of statuses for a timeline/event plan type is defined in Data Administration.
Filing type The filing type (for example, original filing, extension filing, reformatting filing) for the application, which is required only if sequences will be created with the submission.
Keywords Words used to enable a search for entities associated with the submission.
Procedure Type The procedure type for the application, such as National, CP, DCP, or MRP. The list of available options depends on the reviewing country for the submission.
Registration Type 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. This attribute can be configured to default to one registration type and be non-editable.
Reviewing Country The country responsible for performing the submission review. When the submission involves a member of the European Union (EU) and the Procedure Type is Mutual Recognition Procedure (EU MRP) or a Decentralised Procedure (EU DCP), the Countries attribute appears and enables you to select multiple member countries from the EU for the submission. The Reviewing Country is automatically assigned for National procedure types.
Sequence Code The identifier for the sequence associated with the application, which is required only if a sequence will be created. The sequence code defaults to the next available four-digit sequence number, prepended with the letter P to indicate that this is the planned sequence number. This enables working on multiple planned sequences concurrently. When you mark the sequence as submitted, Calyx RIM Manager reconfirms the next available sequence number and removes the P. If you enter a value that deviates from the default format, the wizard displays a message requiring you to confirm that you want to deviate from the default numbering format.

For the first sequence in an application, the start sequence code from the application is always used. For subsequent sequences, all the sequences in the application are considered. When the highest existing sequence number has been determined, the default sequence number for the new sequence is the highest plus one. For example, if there are four sequences with the codes P0000, 0001, 0005, and R0006-512, the next sequence number by default is P0006.