Full Product Presentation Attributes
You create a Full Product Presentation for the Registration to provide the necessary information about the product in the XEVMPD submission for the European Medicines Agency (EMA).
The following attributes describe the specific Full Product Presentation for the Registration.
| Attribute | Description |
|
Application Code |
The agency-identified application number (or identifier). May not be known until submittal time and so it can be the same as the internal code. |
|
Application Name |
The name of your application. |
|
Application Procedure Type |
Application Procedure Type associated to the combination of registration, package set, and country associated. |
| Authorisation Status | The status of the authorisation of a medicinal product. |
| Authorisation/Renewal Date | The date when the first authorisation was granted by the authorising body or the date when the renewal was granted. |
| Attribute | Description |
| Authorised Pharmaceutical Form | The pharmaceutical form of the product. |
|
Container or Pack Part |
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 | All Package Set Countries available for selection. The field appears after the package set is selected in the Package Sets field. For the application of National, Mutual Recognition (MRP) and Decentralised (DCP) Procedure types, the country of the parent Registration is selected by default. |
|
Date Submitted to EMA |
The date is assigned automatically when the XEVMPD Acknowledgment Wizard passes. |
| Device Part | 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 EEA Country is available for selection only when the Application has one of EU CP Types (Centralised Procedure). Countries available for selection are:
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. |
| EV Code | The EudraVigilance (EV) Code of the Master File Location. |
| Flavour Part |
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 Strawber- ry |
|
Formulation Part |
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 full name of the product. For example: DrugLV Filmtabletten |
| Full Product Presen | Available on the Create/Modify Full Product Presentation Attributes pages. The free-format text box where users can add comments. The comments will be displayed in the Full Product Presentation |
| Attribute | Description |
|
tation Add Comment |
Comments box followed by the date and time the comments were entered, and the user ID of the person who entered them. |
| Full Product Presentation Comments |
Available on the View/Modify Full Product Presentation Attributes pages. The display-only field that includes the previously added comments: • 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. Can be updated or deleted from the View Full Product Presentation Attributes page. |
| Full Product Presentation Concerned Parties | 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 | Text that describes the Full Product Presentation. |
| Full Product Presentation Keywords | Words you can use to search for the Full Product Presentation. |
|
Full Product Short Name |
The short name of the product. For example: DrugLV |
|
Information Date |
The date when the information is inserted. |
|
Intended Use Part |
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 Mi- graine |
| Language | Active language names from the languages values in Data Administration. |
| Last Updated Date | The date of the most recent update. |
|
License Code |
The code assigned by the regulatory agency. Current value from Package Set Registration. |
| Attribute | Description |
|
MAH/Or ganisation |
The license issued to a company to market the product. Current value from Package Set Registration in concatenation of MAH/Development Sponsor/Organisation Name + Address + City + Country Code. |
|
MAH/Or ganisation Transferred To |
Available for Authorisation Status when Not Valid - Superseded by Marketing Authorisation Transferis selected for FPP entity. |
|
Message Sender |
This field is read-only and is automatically updated with data when the XEVMPD Submission Wizard is used. Not available on the Create page. |
|
Package Sets |
Package Set associated to Registration. This attribute is related to Package Description.Note: Only package sets with Approved status are available for selection when you create FPP. |
| Package Description | Includes package set names from the Package Sets field. The field appears only if the Package Sets values are defined. |
|
Product Company Name |
Part of the medicinal product name without any other designations such as trade mark, strength, or pharmaceutical form. |
|
Product Form |
The physical form in which this product is produced and dispensed. |
| Product INN/Common Name | 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. |
|
Pharmaceu tical Product |
Pharmaceutical Products are available for selection that are assigned to the Product for the selected Package Sets in FPP. |
|
Product Strength |
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 |
A controlled term that is used to specify the Medicinal Product. |
| Target Population Part | 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 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. |
| Attribute | Description |
| Withdrawn/Invalidated Date | The date of expiry of the marketing authorisation. |
|
XEVMPD Comments |
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. |
|
XEVMPD Marketing Authorisation Number |
The code assigned by the regulatory agency. This field is populated automatically with a License Code value from a parent Package Set Registration via the XEVMPD Submission Wizard. This field is read-only. The value is used for the Invalidate MA operation for Not Valid statuses. |
|
XEVMPD MAH/Or ganisation |
The company to which the license is given to market the product. This field is populated automatically with a MAH/Organisation value from a parent Package Set Registration via the XEVMPD Submission Wizard, and is not available for further modifications. The value is used for the Invalidate MA operation for Not Valid statuses. |
|
XEVMPD Submission Required? |
The system auto-populates this field when XEVMPD related field on XEVMPD related entity is updated. |