FPP Previous EV Code Attributes
You create a Previous EV Code for a Full Product Presentation (FPP) to include it in the XEVMPD submission for the European Medicines Agency (EMA).
The following attributes describe the FPP Previous EV Code for a Full Product Presentation.
| Attribute | Description |
| Application Code | Application to which the combination of Registration, Package Set and Country is associated.Appears as a hyperlink to the parent Application. |
|
Application Name |
Application to which the combination of Registration, Package Set and Country is associated.Appears as a hyperlink to the parent Application. |
|
Autho risation/Renewal Date |
The date when the first authorisation was granted by the authorising body or the date when the renewal was granted.The value is populated by the system and appears as a display-only. |
|
EEA Country |
The EEA Country of the Full product Presentation if the Application has one of EU CP Types (Centralised Procedure).The value is populated by the system and appears as a display-only. |
| Full Product Name | The full name of the product.Appears as a hyperlink to the parent Full Product Presentation. |
|
Full Product Short Name |
The short name of the product.The value is populated by the system and appears as a display-only. |
|
License Code |
The code assigned by the regulatory agency. License code to which the combination of Registration, Package Set and Country is associated Appears as a hyperlink to the parent Registration. |
| Attribute | Description |
| MAH/Organisation | The company to which a license is issued to market the product. Current value from Package Set Registration in concatenation of MAH/Development Sponsor/Organisation Name + Address + City + Country Code.The value is populated by the system and appears as a display-only. |
| Package Description | The list of Package Set descriptions tied to Registration.The value is populated by the system and appears as a display-only. |
|
Package Sets |
The list of Package Set names tied to Registration.The value is populated by the system and appears as a display-only. |
|
Previous EV Code * |
The previous EV code of the Authorised Product, if applicable. Appears as a text field. You can enter up to 60 characters for the previous EV code value. |
|
Product Company Name |
Name of the company, trademark, or manufacturer, if it is part of the Full Product Name (SmPC Name).The value is populated by the system and appears as a display-only. |
|
Product INN/ Common Name |
The generic name, if it is part of the Full Product Name (SmPC Name).The value is populated by the system and appears as a display-only. |