Page 3 of the Application Wizard
This is the final page of the Application Wizard. Here the final pieces of information are added to complete the Application through GlobalSubmit PUBLISH.
United States (FDA)
European Union (EMA)
Canada (Health Canada)
Australia (TGA)
Switzerland (Swiss Medic)
Japan
Applicant: The name of your company.
• This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
• After you create your first application, existing value(s) will be presented in the dropdown list for you to choose from.
Contacts: Phone number and email address of the individual that serves as the point-of-contact to the health authority. To configure a contact through GlobalSubmit PUBLISH:
Select the row.
• In the first column, enter the name of the contact.
• In the second column, specify the type of contact. Choose from:
Regulatory, Technical
United States Agent
Promotional Labeling
Advertising Regulatory Contact
• After selecting type of contact, provide a number or email address by expanding this row to a sub-level by clicking on the + sign.
• In the first column of the sub-level, choose which contact info you want to provide:
Business Phone
Mobile Phone
Email, or Fax Number
• In the second column of the sub-level, enter the contact information.
If you want to continue adding contacts, repeat steps 1-4 above. When you click Finish, the application will be created. If you added the first sequence, the Table of Contents for the sequence will appear in PUBLISH.
Note: This is only applicable to US DTD version 3.3.
Description: Description of the sequence’s contents.
DUNS Number: The unique nine digit numeric identifier used to identify each location of your company in the Dun and Bradstreet Database. Only applicable to US DTD version 3.3.
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating.
Sequence Number: Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence).
Sequence/Submission Type: Choose from the region-specific list provided.
Applicant: The name of your company.
• This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
• After you create your first application, existing value(s) will be presented in the dropdown list for you to choose from.
Sequence Number: Unique four-digit number, generally the next number in the sequence, (0000 is typically used for the first sequence).
Regulatory Activity: Choose from the list provided.
Sequence Type: Choose from the region-specific list provided.
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating.
Description: Description of the sequence’s contents such as “Original MAA application” or “Responses to questions on Type II variation for ‘Treatment of Pain’ indication.”
Tracking Number: Enter a number used by an agency or yourself to track the submission, in any procedure, in relation to the product. This could be one or more of the following:
• MRP/DCP number
• National procedure number
• EMEA application number
• An authorization or license number
• Any other number used by an agency to track a submission
• A number used by you to manage the submission within your company
Mode: This field should have a value in variation or line extension regulatory activities and must be included in every sequence of that activity.
• Enter Single, Grouping, or Worksharing.
• This information should be identical with the information provided/ticked in the application form.
High Level Number: Must be provided if Mode is Grouping or Worksharing.
• For Worksharing, enter the worksharing number.
• For Grouping, enter the group number/periodic report number.
Applicant: The name of your company.
• This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
• After you create your first application, existing value(s) will be presented in the dropdown list, for you to choose from.
Sequence Number: Unique four-digit number, generally the next number in the sequence. The first sequence must be 0000 and subsequence sequences must be in ascending numerical order.
Regulatory Activity Type: Choose from the list provided.
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating.
Regulatory Activity Lead: Choose from the list provided.
Sequence Type: Choose from the region-specific list provided.
Applicant: The name of your company.
• This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
• After you create your first application, existing value(s) will be presented in the dropdown list, for you to choose from.
Data Types: Check all the applicable type of data contained within this data submission.
Description: Description of the sequence’s content such as Safety Related Notification or Period Safety Update Report.
eBS: Enter the eBS number given to you.
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating.
Sequence Number: Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence).
Sequence Type: Choose from the region-specific list provided.
Applicant: The name of your company.
• This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
• After you create your first application, existing value(s) will be presented in the dropdown list for you to choose from.
Sequence Number: Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence).
Sequence Date: Date sequence is being created.
Sequence Type: Choose from the region-specific list provided.
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating.
Description: Description of the sequence’s contents such as New Active Substance or Renewal of a Marketing Authorization.
DMF Holder: The name of the company submitting the DMF. Enter n/a (case sensitive) if the submission is not a DMF.
DMF: The number assigned to the DMF (alphanumeric).
• Enter pending (case sensitive) if the assigned DMF number is not known.
• Enter n/a (case sensitive) if the submission is not a DMF.
PMF Holder: The name of the company submitting the PMF. Enter n/a (case sensitive) if the submission is not a PMF.
PMF: The number assigned to the PMF.
• Enter pending (case sensitive) if the assigned PMF number is not known.
• Enter n/a (case sensitive) if the submission is not a PMF.
Paragraph 13 TPA: Check if compliant.
Applicant: The name of your company.
• This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
• After you create your first application, existing value(s) will be present in the dropdown list for you to choose from.
Sequence Number: Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence).
Sequence Date: Date sequence being created.
Sequence Type: Choose from the region-specific list provided.
Legal Notice | Contact Certara
© Certara USA, Inc. All rights reserved.