Copy Full Product Presentation Attributes
The following attribute descriptions can help you to enter appropriate Full Product Presentation attribute values when copying a Full Product Presentation in Ennov InSight .
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:
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 Presentation Description |
Appears blank. Text that describes the Full Product Presentation. |
|
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. |
|
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). |
| Attribute | Description |
| 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. |
|
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 |
| Attribute | Description |
| 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. |
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 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). |
| Attribute | Description |
| 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:
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. |
|
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. |
| Attribute | Description |
| 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. |