Registration Maintenance
Registration values appear in lists on the Registration Attributes page and are designated when a registration is created or modified. Data Administration enables you to add and modify list values, and set the status of a value to active or inactive.
When you select a value under Registration Maintenance, a table of all values that have been defined appears. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.
Note: The proper data administration access privileges are required to view and modify registration maintenance values.
All XEVMPD Data Administration tables provide the ability to configure extra fields. The standard set consists of twenty extra text fields, five extra date fields, and five extra number fields.
Registration Maintenance: Registration Status Values
You can create and maintain the following registration values:
| Value | Description |
| EMA Authorization Status | The status of a medicinal product registration that uses the EMA controlled vocabulary. The default value is set to Active. The standard set of extra fields can be configured for this value. |
| Value | Description |
|
Qualified Person Responsible for Pharmacovigilance (QPPV) |
Individual residing within the European Economic Area (EEA) and is responsible by law for the safety of a human pharmaceutical product within the EEA. The QPPV must register with EudraVigilance. The EV registration system assigns the QPPV code to the QPPV responsible for the authorized medicinal product. The code is defined in the pharmacovigilance system master file. The standard set of extra fields can be configured for this value. |
| Registration Status | The status of a registration can be Planned, Active, Pending, Expired, or Withdrawn. |
| Note: The Internal System Status field includes an internal status named APPROVED. This value is used to maintain the IDMP (Identification of Medicinal Products) compliance. | |
| The RMS value is mapped to the Registration Entitlement Status RMS List | |
| Content of Change | The content of change provided for the IDMP attachment. |
| Data Carrier Type Values | The Data Carrier Type values are used when using different packaging levels of medicinal products. The RMS value is mapped to the Source of Information SPOR RMS List. |
| Provenance Reason Values | The reason of provenance to provide additional clarity on requirements for Postmarketing surveillance (PMS) submissions. |
| Master File Type Values | The type of master file indicated for the registrations. |
| Marketing Status | Marketing status for the medicinal products. This Data Administration list is mapped to the Marketing Status available in the SPOR RMS list. |
| Risk of Shortage of Supply Reason Values | Reason for updating the shortage of drug supply to the market. |
EMA Authorization Status Attributes To define an EMA authorization status value, enter values for the following attributes:
| Attribute | Description |
| Authorization Status | Status of the authorization/registration of a medicinal product. |
| Status Code | Authorization status code associated with the selected Authorisation Status. |
| RMS Term Name | List of EMA Authorization Status RMS Values must be available for selection. |
| Attribute | Description |
| Last User Updated | Indicates the name of the user who last created/updated the EMA authorization status. By default, this option is read-only. It is populated automatically when updates were made to the table |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Active | Indicates if the entity is active or inactive. |
Qualified Person Responsible for Pharmacovigilance (QPPV) Attributes
To define a qualified person responsible for pharmacovigilance (QPPV) value, enter values for the following attributes:
| Attribute | Description |
| QPPV Name | Internal Company QPPV Name. |
| QPPV Code |
QPPV Code for the Qualified person responsible for Pharmacovigilance. Should be unique in the system. The EV Registration System QPPV code assigned to the QPPV detailed in the Pharmacovigilance System Master File in place for the product.Format of this code is USRnnnn. The value must match a current user who is designnated QPPV within the EV registration system and who is a member of the same EV Group as the Sender organisation. Should be unique in the system. |
| Last User Updated | Indicates the name of the user who last created/updated the qualified person responsible for pharmacovigilance (QPPV). By default, this option is read-only. It is populated automatically when updates were made to the table |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Active | Indicates if the entity is active or inactive. |
Registration Status Attributes
To define a registration status value, enter values for the following attributes:
| Attribute | Description |
| Name | Name given for the Registration Status. |
| RMS Term Name | List of Regulatory Entitlement Status RMS Values available for selection. |
| Attribute | Description |
| Default Flag | Flag to indicate if the product status is the default.Yes and No values are available for selection. |
| System Process Default Flag | Enables you to select which status will show for a Registration after the Event is closed. |
| Internal System Status | Internal status associated to the Registration status. |
| Last User Updated | Indicates the name of the user who last created/updated the registration status. By default, this option is read-only. It is populated automatically when updates are made to the table |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Active | Indicates if the entity is active or inactive. |
Content of Change Attributes
To define a content of change value, enter values for the following attributes:
| Attribute | Description |
| Content of Change Name | Name given to the Content of Change. |
| Last User Updated |
Indicates the name of the user who last created/updated the content of change. By default, this option is read-only. It is populated automatically when updates are made to the table |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Activate/Deactivate | Indicates if the entity is active or inactive. |
Data Carrier Type Attributes
To define a data carrier type value, enter values for the following attributes:
| Attribute | Description |
| Data Carrier Type Name | Name of the Data Carrier Type. |
| Data Carrier Identifier Source | Indicates the source of data carrier identifier for medicinal product packaging. Values are taken from the Data Carrier Identifier Source Values Data Administration List. |
| RMS Term Name | List of Source of Information RMS Values available for selection. |
| Attribute | Description |
| Last User Updated | Indicates the name of the user who last created/updated the data carrier type. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Active | Indicates if the entity is active or inactive. |
Master File Type Attributes
To define a master file type value, enter values for the following attributes:
| Attribute | Description |
| Master File Type Name | Name of the Master File Type. |
| Last User Updated |
Indicates the name of the user who last created/updated the master file type. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Active | Indicates if the entity is active or inactive. |
Provenance Reason Attributes
To define a provenance reason value, enter values for the following attributes:
| Attribute | Description |
| Provenance Reason Name | Name for the provenance reason. |
| Last User Updated | Indicates the name of the user who last created/updated the provenance reason. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Active | Indicates if the entity is active or inactive. |
Marketing Status Attributes
To define a marketing status value, enter values for the following attributes:
| Attribute | Description |
| Marketing Status Name | Name to define the Marketing Status for the medicinal products. |
| Last User Updated | Indicates the name of the user who last created/updated the marketing status. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Active | Indicates if the entity is active or inactive. |
Risk of Shortage of Supply Reason Attributes
To define a risk of shortage of supply reason value, enter values for the following attributes:
| Attribute | Description |
|
Marketing Status Reason Name |
Name to define the reason for the Marketing Status of the medicinal products. |
| Last User Updated | Indicates the name of the user who last created/updated the marketing status reason. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table. |
| Active | Indicates if the entity is active or inactive. |