About the Copy Package Set Registrations Wizard

In the Copy Package Set Registration wizard, you can select one of the available flows and copy a Package Set

Registration. The new Package Set Registration appears under the same Application as the source Registration.

Important: The Copy Package Set Registration wizard can be invoked for a Registration under an Application with a

Package Set Registration type.Security InformationYou must have at least WRITE permissions for Registrations and Full Product Presentation (FPP) in the Security Administration > Entity Security section to copy Registrations and assigned Full Product Presentations (applicable for the New Package Set specific Registration(s) flow).Note: WRITE permissions for Registrations is enough to copy the Package Set Registration without copying the associated Full Product Presentations.Wizard Navigation

The Copy Package Set Registration wizard consists of multiple pages described in the tables below. The wizard navigates you through those pages depending on the selected flow.

When the Copy Package Set Registration wizard is invoked on the Registration Attributes page, the Select Wizard Flow page appears listing the copy flows available for selection:

  • New Package Set specific Registration(s)
  • New Product specific Registration(s)

Wizard Navigation: New Package Set specific Registration(s) flow

The following table describes the Copy Package Set Registration > New Package Set specific Registration(s) wizard flow.

Wizard

Page

Name

Values Available for Selection Description

Selec Product De­

tail

Set

 t
  • Country drop-down field, required
  • Product Detail Set drop-down field, required
  • Copy License Code check box

The following are specific rules applicable to the Product Detail Set required multi-select field:

  • Nothing is available for selection if there are no Package Sets associated to a Registration you select to copy.
  • At least one Package Set must be associated to the Registration you select to copy, and at least one approved but not associated (to any Registration) Package Set must exist.Note: If this rule is met, the parent Product Detail Set is selected by default in the Product Detail Set field.
  • The Package Sets associated to a Registration you select to copy can have different parent Product Detail Sets. The parent Product

Detail Set that has more Package Set details with Approved status (and at the same time those details are not associated to the Registration you select to copy) is selected by default in the Product Detail Set field. The other Product Detail Sets are also available for selection.Note: If the quantity of Package Sets that have the Approved status and are not associated to the Registration is equal among all

Wizard

Page

Name

Values Available for Selection Description

Product Detail Sets, then the Product Detail Sets are alphabetically sorted and the one that is the first in the list is set by default.

• For the Country field, the Package Sets will be available only if the selected country already has the assigned Registration.

The Copy License Code check box is selected by default. You can clear it, so the License Code field appears blank on the Select Package Set(s) page.

Selec Package

Set(s)

t The list of all Package Sets

available for selection.
  • Multiple Package Sets can be selected.
  • License Code value for the selected Package Set must be added or updated.
Enter esignature information

When the e-signature option is configured, the following fields appear:

  • Reason
  • Reason for Comments
  • User ID
  • Password

When the e-signature option is not configured, the following message appears:

No input required on this page

.

Copy

Full Product Presentation

 When at least Write permissions for the Full Product Presentation (FPP) are set in the Entity Security section, the Copy Full Product Presentation drop-down field appears with Yes and No values available for selection. Yes is selected by default. When permissions for the Full Product Presentation (FPP) the in Entity Security section are set to None, or Read, the Summary page appears instead of the Copy Full Product Presentation page.

Selec

Full Product

Pre­

t If you selected Yes on the

Copy Full Product Presenta-

tion page, the list of all available Full Product Presenta­

The following message appears:

No input is required on this page

, if you selected No on the Copy Full Product Presentation page.

Wizard

Page

Name

Values Available for Selection Description
sentation(s

tions displays the following columns:

)

  • Full Product Name
  • EEA Country
  • Language
  • Authorisation/Renewal Date
  • Attachment Name­

Note: If there are more than one Registration FPP Attachment associated to a Full Product Presentation, then all Registration FPP Attachments are displayed as comma-separated values.

You can select one, or more Full Product Presentations to copy with the Registration, by checking the appropriate check boxes.Note: You can proceed without making any selection.

Summa­

ry

Page

 The messages presented on this page differ based on the previous selections.Note: If there are no Full Product Presentations associated to the Registration you select to copy, the Summary Page appears after you click Next on

The following messages can appear:

  • Registration [License Code] has been created. One line per each created registration is displayed. License Code is a hyperlink to the created entity.
  • Full Product Presentation has been copied. Full Product Presentation is a hyperlink to copied entity. This message is not displayed if

Wizard

Page

Name

Values Available for Selection Description
the Enter e-signature information page.

you did not select an option to copy Full Product Presentations, or if you do not have appropriate permissions to copy them.

• Registration FPP Attachment(s) has been copied. The message is displayed if there is an attachment under the source Full Product Presentation. If not, the message is not shown.

Wizard Navigation: New Product specific Registration(s) flow

The following table describes the Copy Package Set Registration > New Product specific Registration(s) wizard flow.

Wizard

Page

Name

Values Available for Selection Description

Copy License

Code
  • Country drop-down field, required
  • Copy License Code check box.

Copy License Code is selected by default and displays the License Code value on the Select Product Name page. If you clear this check box, the License Code field on the Select Product Name page will be blank.

For the Country field, the Package Sets will be available only if the selected country already has the assigned Registration.

Select

Product

Name

 The list of all Package Sets available for selection.

Multiple Product Names can be selected.

The following columns are displayed:

  • Product Name
  • PDS Name
  • License Code

The License Code value for the selected Product Names must be added or updated.

To display the Product Name on the Select Product Name page, the following specific conditions must be met:

Wizard

Page

Name

Values Available for Selection Description
  • The Product must be associated to the same Application as the source Registration and must have an assigned PDS.
  • The PDS assigned to a specific Product must have at least one Approved Package Set that is not yet associated to any Registration.
Enter esignature information

When the e-signature option is configured, the following fields appear:

  • Reason
  • Reason for Comments
  • User ID
  • Password

When the e-signature option is not configured, the following message appears:

No input required on this page

.

Summa­

ry Page

The following confirmation message appears: Registra-

tion License Code has been created.
  • If multiple Product Names have been selected on the Select Product Name, one line per each newly created registration is displayed on the Summary page.
  • License Code value is a hyperlink to the created registration.