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Click the thumbnail to view the process
stps for that submission project.
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Title
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The title of the submission project.
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Sub. Type
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The
submission type used by this submission project.
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Reg. Category
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The Regulatory Category used by this
submission project.
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Reg. Authority
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The
Regulatory Authority that the submission project
will be submitted to for approval.
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Activity Category
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The dossier defined for this submission.
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Activity Sub
Category
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The subcategory for the activity category.
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Next Milestone
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The name of the next milestone that has a
defined Milestone Purpose. Click to open the Schedule page for the milestone.
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Owner
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The person responsible for the submission
project.
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Description
|
Details about the submission project.
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Authority Application
Number
|
The application number assigned when the
regulatory authority receives the dossier. This number should be used on all
subsequent correspondence.
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Dossier Submitted
|
The milestone dates for dossier submission.
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Est. Finish Date
|
The estimated date that the dossier will be
submitted.
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Act. Finish Date
|
The actual date on which the dossier was
submitted.
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Market Authorization
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The milestone dates for market
authorization.
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Est. FInish Date
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The estimated date that market
authorization will be granted.
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Act. Finish Date
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The actual date that market authorization
was granted.
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