| Name | The automatically generated name for the submission master record. |
| Title | The descriptive name for the submission master record. |
| Type | The item type: Submission Master Record. |
| Regulatory Submission Type | The submission type defined for the submissions. All regulatory contexts for the submissions managed by this master record use the same submission type. Click to open the Properties page for the submission type. |
| Regulatory Category | The regulatory category for the submissions. All regulatory contexts for the submissions managed by this master record use the same regulatory category. Click to open the Properties page for the regulatory category. |
| Modified On | The most recent date any changes were made to the submission master record. |
| Description | Descriptive details about the submission master record. |
| Owner | The person with the Regulatory Lead role who is responsible for the submission master record. |
| Follows Leading Country | Indicates whether the countries associated with this submission project follow the regulatory lead of another country.| Possible Value | Description |
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| As Defined | The defined leading/following countries relationship is used, and the Leading Country field shows the name of the lead country. | | Not Required | Any defined leading/following countries relationship is not used, and the Leading country field is blank and cannot be edited. | | With Deviation | The normal leading/following countries relationship is not used, but the country for the context submission will follow another country. The Regulatory Lead must select a leading country. |
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| Leading Country | The country that all of the countries associated with the submission project follow for regulatory affairs. |
| Group Products Under One MA | Specifies whether a market authorization covers multiple products per country when it is created:| Value | Description |
|---|
| Yes | A single market authorization is created to cover multiple products per country. | | No | A market authorization is created for each product per country. |
This field takes its value from the submission's equivalent field when the submission master record is created. All submissions created from this submission master record (for example, renewals) have the same value for this field as the parent submission master record, but the field is not visible in those new submission projects. Note:
If this value is defined as No, a separate market authorization is created for each product per country. Additional products can be added to any of these market authorizations after they are released. Therefore, this value does not necessarily mean that the market authorizations can only ever cover one product per country, just that they did at the time they were created.
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| Upcoming Dates | Start Renewal | Date by which the renewal submission process must start. |
| Expiration | The earliest expiration date from the submissions managed by this submission master record. |
| Restricted Authorization | Scope of Authorization | Shows Restricted if the regulatory activity category is Restricted Authorization. For all other regulatory activity categories, shows as Full. |
