| Action Type
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The type of approval required to consider the event active.
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| Application Code
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Code for the application you are copying.
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| Application Name
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Name of the application you are copying.
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| Available Countries/Selected Countries
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Countries for which the new application is being created.
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| Comment
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Free format text box where users can enter information that will be stamped with the date/time/userid of the person entering the information.
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| Description
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Free format text box for entering descriptive information.
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| Event Code
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Code for the event being created for the new application.
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| Event Concerned Parties
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Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses.
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| Event Name
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Name for the event being created for the new application.
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| Event Type
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Type of Regulatory action taking place.
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| Event-Country Status
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The status of the event.
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| Keywords
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Free format text box where users can enter text for searching purposes
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| PSUR Flag
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Indicate whether the event is a safety event.
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| PSUR Reason/Comment
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Enter a description for the PSUR.
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| PSUR Report Code
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The code for the PSUR.
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| Reviewing Country
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The country reviewing the application.
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| Secondary Event Type
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Secondary Event Type Values based on selected Event Type Value.
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| Status Date
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The effective date of the event status, cannot be greater than today's date plus one day.
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| Variation Number
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The regulatory agency-assigned number that identifies the event as a variation of a submission.
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