Draft
For Project Space projects, as used in
Project Management,
the project space object owner or lead can add team members, create phases and
tasks, and assign them to members.
For Submission projects, the Regulatory Lead creates the submission
project (possibly from a submission template) and connects it to a product,
defines the schedule for submitting the dossier, and adds a regulatory calendar
template to the schedule.
The Regulatory Lead defines the regulatory information for the
submission depending on the submission type defined by the regulatory context
for the submission project:
- Centralized Procedure submission type: add leading country and
following countries
- Mutual Recognition Procedure or Decentralized Procedure: add
countries to the submission
The Regulatory Lead defines the regulatory information for the
product, such as storage conditions and indications. The Regulatory Lead
promotes the submission project to the Ready state.
For Submission Master Records, when you promote a submission project for an Initial Submission
to "To Do", Market Registration creates a submission master record in the Draft state.
When promoting a submission project from Draft to To Do, if the Group Products Under
One MA field on the regulatory information
Properties page of the submission project is set to No, Market Registration creates a separate market authorization and market authorization change for each
product for each country. When promoting a submission project from Draft to To Do,
if the Group Products Under One MA field on the regulatory
information Properties page of the submission project is set to
Yes, Market Registrationn creates a single market authorization and market authorization change for all
products for each country.
To Do
For Project Space projects, when the project space object is promoted
to this state, the assigned tasks are available to the assignees.
For Submission projects, an initial Submission is promoted to To Do, Market Registration creates a submission master record, market authorization and market authorization
change object, and it sets the Scope of Authorization attribute for those items to
Full.
For a submission project that uses the Restricted Authorization
regulatory activity category,
Market Registration
creates a submission master record, market authorization and market
authorization change object, and it sets the Scope of Authorization attribute
for those items to Restricted.
The Regulatory Lead creates requests for work and assigns them to the
appropriate people. Requests involve the work required to prepare, review, and
submit the regulatory dossier.
When all tasks required to complete the Dossier Ready milestone are
completed,
Market Registration
promotes the submission project to the In Work state.
In Work
For Project Space projects, when the task assignees start working on
the tasks, the project space object advances to this state.
For Submission projects, the Regulatory Users complete all tasks
required for the Dossier Published, Dossier Submitted, and Dossier Received
milestones.
After the regulatory authority receives the dossier, the Regulatory
Lead manages correspondence, and question-and-answer phase of the submission
process.
The Regulatory Lead, after receiving market authorization from the
regulatory authority, updates the Regulatory Information for the submission
project with the market authorization details, and enters the End Date for the
Market Authorization milestone in the schedule.
Market Registration
adds an approval route to the lifecycle for the submission project, and
promotes the submission project to the In Review state. The route includes
approval tasks for reviewing the submission results.
In Approval
For Project Space projects, when all phases are completed, the
project space object is promoted to this state.
For CAPA projects, when a CAPA is promoted to the In Approval state, an approval route is
automatically created between the In Approval and Completed states. A task is
assigned to the CAPA owner for approving the CAPA . If the CAPA is demoted back to
the In Approval state, a new route is created between the In Approval and Completed
states. Note:
You cannot manually promote a CAPA from the In Approval state to the
Completed state.
For Submission projects, all involved Regulatory Users approve their tasks. The Regulatory Lead
updates the market authorization change, and approves it for update. Market Registration enters "Consensus Reached" for the dossier submission, and promotes the
submission project to Completed.
Completed
For Project Space projects, once the owner approves the route in between the In Approval and
Completed states, the object is automatically promoted to the Completed state.
For Submission projects, the project remains in the Completed state until another regulatory
activity requires action, such as a renewal supplement, repeal, or other activity.
At that point, a new submission project for that purpose is created, and this
submission project is promoted to Archived.
Archived
For Project Space projects, the project owner can move the
unused, completed project space object to this state.
For Submission Projects, archived projects are obsolete and used as
reference only. You cannot promote or demote a submission project after it is
archived.
For Submission Master Records, when all market authorizations
associated with a submission master record have been promoted to Obsolete,
Market Registration
automatically promotes the submission master record to Archived.
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