Copying Full Product Presentation under the Same Registrations

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


Attribute	Description
Authorisation Status	Appears blank. 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	Appears blank. The date when the first authorisation was granted by the authorising body or the date when the renewal was granted.
Authorised Pharmaceutical Form	The value is taken from the source Full Product Presentation and can be changed, if needed. The pharmaceutical form of the product.
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)
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.
Attribute	Description
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	Appears blank. Text that describes the Full Product Presentation.


Presentation 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	Appears blank. The date when the information is inserted.
Attribute	Description
Intended Use Part	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.
Package Description	The value is taken from the source Full Product Presentation and can be changed, if needed. A brief package description of the pack size(s) corresponding to the referenced authorisation number.
Package Sets	The value is taken from the source Full Product Presentation and can be changed, if needed. Package Set names tied to Registration. This attribute is related to Package Description.


	*Note:* Only package sets with Approved status show on the Full Product Presentation Attributes page.

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.
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.
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
Pharmaceutical Product	Pharmaceutical Products are available for selection that are assigned to the Product for the selected Pack Sets in FPP.
Withdrawn/ Invalidated Date	Appears blank. 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.