European_Union

For the European Union region, the second page of the Application Wizard contains the following fields.

Sponsor Identifier: Sponsor, Company Name, i.e., Synchrogenix.

Procedure: Choose from the list provided.

Country: The country information is automatically provided in a list to select from.

Agency: Values in this list are dependent on the country selected for eCTD applications. This field is NOT required for NeeS submissions.

Product Information: Enter at least one product name. Each Product Name must have an associated Product Type. At least one product of the type Invented Name must be provided.

The third page of the Application Wizard contains the following fields.

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.