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).
| 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. |
| Authorisation/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. |
| MAH/Organisation | The company to which a license is given 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. |