| Title | A descriptive title for the submission. |
| Registration Fee | The fee paid to the regulatory authority for processing the submission. |
| Current Phase | The current Schedule phase of the submission. Click to open the Schedule page for the phase. |
| Next Milestone | The name of the next milestone that has a defined Milestone Purpose. Click to open the Schedule page for the milestone. |
| Authority Application Number | The application number assigned when the regulatory authority receives the dossier. This number should be used on all subsequent correspondence. |
| Publishing File Format | The file format required by the regulatory authority:- eCopy: The electronic submission is an exact duplicate of the paper-based submission. (You must select this format to see the Publishing category for a submission.)
- eCTD: The electronic submission content is based on the Common Technical Document (CTD) format.
- NeeS: The electronic submission is in a non-eCTD format.
- Paper-based: The submission is paper-based.
|
| Regulatory Activity Category | The dossier defined for this submission. |
| Regulatory Activity Sub Category | The subcategory for the activity category. |
| Follows Leading Country | Indicates whether the countries associated with this submission project follow the regulatory lead of another country. | Possible Value | Description |
|---|
| 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. |
|
| Leading Country | The country that all of the countries associated with the submission project follow for regulatory affairs. |
| Group Products Under One MA Only shows when the Regulatory Activity Category is Initial Submission. | 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 template's equivalent field
when the submission is created. If the submission was not created from a
template, the default value is No. This value can be
edited by the Regulatory Lead when the submission is in the Draft
state. Note:
If this value is set to 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.
|
| Reason for Change | Only shows if the submission is beyond the Draft state. Justification for
changes made to the regulatory information for a submission after it is
started. |
| Status | Dossier Submitted | The type of submission evaluation:- Evaluation
- Consensus Achieved
- Referral
- Appeal
Regulatory Request Responders take this dossier evaluation type into consideration when preparing documents. |
| Result | The overall result of the submission. This column is blank until the results are entered. How the regulatory authority ruled on the submission: - Approved
- Rejected
- Withdrawn
|
| Lead Submission | The name of the submission that groups multiple submissions (including this one) for various regulatory activities. Click to view the Properties page for that submission. |
| Submission Master Record | The name of the submission master record associated with this submission project. Click to open its default page. |
| Source Request | A hyperlink to the regulatory request from which the submission was created. |
| Cancellation This section shows only if the submission is on hold or was cancelled. | Date | If the submission was cancelled, the date it was cancelled. |
| Type | The type of cancellation:- Cancelled
- Not Submitted
- Withdrawn
|
| Reason | Explanation of why the submission was cancelled. |
| Milestones | List of all milestones that have a milestone purpose defined. |
| Notes | Any notes entered for this submission project. |
| Contract Number | Only shows if the submission master record is Restricted. The contract number of the restricted authorization. |
| Restricted Authorization Request Date | Only shows if the submission type is Restricted. The date that the regulatory authority grants restricted authorization. |
| Wave Reference | Only shows if the submission type is Initial Submission. The wave reference for a submission that uses the Mutual Recognition Procedure (MRP). If you derive a submission project from this one, you need to manually edit this value. |
