Copying Full Product Presentation under Different Registrations

Use the following descriptions to choose and enter Full Product Presentation values when copying under different Registrations. Required information is indicated by an asterisk (*):


Attribute	Description
Authorisation Status	The value is taken from the source Full Product Presentation and can be changed, if needed. The status of the authorisation of a medicinal product. The statuses available for selection are all Active values from the Data Administration > Authorisation Status Values section.
Authorisation/ Renewal Date	The value is taken from the source Full Product Presentation and can be changed, if needed. The date when the first authorisation was granted by the authorising body or the date when the renewal was granted.
Authorised Pharmaceutical	The value is taken from the source Full Product Presentation and can be changed, if needed. The pharmaceutical form of the product.


Form
Container or Pack Part	The value is taken from the source Full Product Presentation and can be changed, if needed. The Container or Pack Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for The value. The database size of the field is VARCHAR2(500). For example: DrugLV, collapsible aluminium tube
Countries	The value is taken from the source Full Product Presentation and can be changed, if needed. All Package Set Countries available for selection. The field appears after the package set is selected in the Package Sets field.
Device Part	The value is taken from the source Full Product Presentation and can be changed, if needed. The Device Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: DrugLV, solution for injection in pre-filled pen (device Tradename)
Attribute	Description
EEA Country	The value is taken from the source Full Product Presentation and can be changed, if needed. The EEA Country is available for selection only when the Application has one of EU CP Types (Centralised Procedure). Countries available for selection are: — Iceland — Norway — Liechtenstein If any of the listed countries is selected, then it is included to the XEVMPD XML file. Otherwise, the Country from Package Set Registration is added to the XML file.
Flavour Part	The value is taken from the source Full Product Presentation and can be changed, if needed.


	The Flavour Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: DrugLV for Children Strawberry
Formulation Part	The value is taken from the source Full Product Presentation and can be changed, if needed. The Formulation Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: DrugLV, sugar free
Full Product Name *	The value is taken from the source Full Product Presentation and can be changed, if needed. The full name of the product. For example: DrugLV Filmtabletten
Full Product Presentation Add Comment	Appears blank. The discussion thread that includes all comments entered by users, including the date and time the comments were entered, and the user ID of the person who entered them.
Full Product Presentation Concerned Parties	Appears blank. Contains email addresses and User IDs for which Notifications can be sent. Concerned parties are anyone who may be copied on notifications about this entity; use semi-colons (;) to separate e-mail addresses
Full Product Presentation Description	Appears blank. Text that describes the Full Product Presentation.
Attribute	Description
Full Product Presentation Keywords	Appears blank. Words you can use to search for the Full Product Presentation.


Full Product Short Name	The value is taken from the source Full Product Presentation and can be changed, if needed. The short name of the product. For example: DrugLV
Information Date	The value is taken from the source Full Product Presentation and can be changed, if needed. The date when the information is inserted.
Intended Part Use	The value is taken from the source Full Product Presentation and can be changed, if needed. The Intended Use Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: DrugLV 200 tablet Migraine
Language	The value is taken from the source Full Product Presentation and can be changed, if needed. Active language names from the languages values in Data Administration. By default, the field is hidden.
Product Company Name	The value is taken from the source Full Product Presentation and can be changed, if needed. Part of the medicinal product name without any other designations such as trade mark, strength, or pharmaceutical form.
Product Form	The value is taken from the source Full Product Presentation and can be changed, if needed. The physical form in which this product is produced and dispensed.
Product INN/ Common Name	The value is taken from the source Full Product Presentation and can be changed, if needed. The international nonproprietary name recommended by the World Health Organization (WHO), or, if one does not exist, a nonproprietary name recommended by the jurisdiction within which the name is used.


Attribute	Description
Product Strength	The value is taken from the source Full Product Presentation and can be changed, if needed. The name of the strength and strength unit, if it is part of the Full Product Name (SmPC Name). For example: DrugLV 200 mg
Special Measures	The value is taken from the source Full Product Presentation and can be changed, if needed. A controlled term which is used to specify the Medicinal Product. By default, the field is hidden.
Target Population Part	The value is taken from the source Full Product Presentation and can be changed, if needed. The Target Population Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: DrugLV For Children. By default, the field is hidden.
Time Period Part	The value is taken from the source Full Product Presentation and can be changed, if needed. The Time Period Part of the Full Product Name (SmPC Name). You can enter up to 250 characters for the value. The database size of the field is VARCHAR2(500). For example: DrugLV 300 mg EXPRESS By default, the field is hidden.
Withdrawn/ Invalidated Date	The value is taken from the source Full Product Presentation and can be changed, if needed. The date of expiry of the marketing authorisation.
XEVMPD Comments	The value is taken from the source Full Product Presentation and can be changed, if needed.
	The discussion thread that includes all comments entered by users; includes the date and time the comments were entered and the user ID of the person who entered them.

Copy a Full Product Presentation under the Same Registration

Use this procedure to copy a Full Product Presentation (FPP) under the same registration.

To copy a full product presentation:

Go to the Full Product Presentation tab, or in the navigation pane select Full Product Presentations.
Select the Full Product Presentation entity you want to copy.
On the Full Product Presentation Attributes page, click Copy. 4. The Copy Full Product Presentation page appears. Under Select wizard flow > Select the flow for the Full Product Presentation copy you would like to perform, select Full Product Presentation under same Registration.

Click Next.
On the Copy Full Product Presentation Attributes page, enter or change the attributes for the Full Product Presentation Copy.
When entering or modifying the Copy Full Product Presentation Attributes, remember that the concatenation of

Full Product Name, EEA Country, Language, Package Description, Authorisation Status, Authorisation/Renewal Date, and EV Code must be unique for a Registration.
Click Next.
The Summary page indicates that the Full Product Presentation has been copied.
Select a reason and enter comments for the reason.
Click Next.
Choose the applicable procedure to enter an electronic signature for entities:


Scenario	Steps
When electronic signature is enabled	Select a reason and enter comments for the reason. Select Save. Validate your identity by entering your user credentials in the dialog box.

Copy a Full Product Presentation under Different Registrations

Use this procedure to copy a Full Product Presentation (FPP) under different registrations.

To copy a full product presentation:

Go to the Full Product Presentation tab, or in the Navigation Pane select Full Product Presentations.
Select the Full Product Presentation entity you want to copy.
On the Full Product Presentation Attributes page, click Copy. 4. Copy Full Product Presentation page appears. Under the Select wizard flow > Select the flow for the Full Product Presentation copy you would like to perform page, select Full Product Presentation under different Registration(s).

Click Next.
The Select Registration(s) under which you would like to copy Full Product Presentation page appears with the registrations to which you can copy the Full Product Presentation. The search is performed by the following values: — License Code

— License Status

— Package Sets. If there are several Package Sets, they are displayed as comma delimited.

— Product Detail Set. If there are several Product Detail Sets, they are displayed as comma delimited. — Country. The Country value from Package Set Registration.

— Application Code

— Application Name — Application Type

Only the Package Set Registration(s) that meet the following criteria are displayed on the Select Registration(s) under which you would like to copy Full Product Presentation page:

— The available Registrations have the same parent Application as the Registration of the source Full Product Presentation.

— The parent Registration > Country value of the available Registrations matches the parent Registration > Country value of the source Full Product Presentation.

Note: The source Registration is not displayed.

On the Select Registration(s) under which you would like to copy Full Product Presentation page, select one or more registrations and click Next.
On the Copy Full Product Presentation Attributes page, enter or change the attributes for the Full Product Presentation Copy.
When entering or modifying the Copy Full Product Presentation Attributes, remember that the concatenation of

Full Product Name, EEA Country, Language, Package Description, Authorisation Status, Authorisation/Renewal Date, and EV Code must be unique for a Registration.
Click Next.

On the Copy Registration FPP Attachment page:


Option	Action
If the Full Product Presentation you are copying has at least one Registration FPP Attachment assigned:	Select Yes to copy the Registration FPP Attachment data, or No to proceed without copying the Registration FPP Attachment data.
	*Note:* The Yes value is selected by default.

If the Full Product Presentation you are copying does not have any Registration FPP Attachments assigned:	The message No input is required on this page message appears.

Click Next.
The Summary page indicates that the Full Product Presentation has been copied. If multiple registrations have been selected, the list is provided of all selected registrations displayed as License Code values, one line per each Registration.

— The message Package Set and Package Description have been populated with the parent registration package set appears, if the values are available.

— The messagePackage Set and Package Description have not been populated as values are absent on the parent registration package set appears, if the values are not available.

If there were any Registration FPP Attachments assigned and you selected Yes on the Copy Registration FPP

Attachment page, the message Registration FPP Attachment(s) has been copied appears.
Select a reason and enter comments for the reason.
Click Next
Choose the applicable procedure to enter an electronic signature for entities:


Scenario	Steps
When electronic signature is enabled	Select a reason and enter comments for the reason. Select Save. Validate your identity by entering your user credentials in the dialog box.