Registration Maintenance: Registration 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.
Medicinal Product Type	Defines values that are used to distinguish product type. The list contains Codes for the medicinal product type term/name from the EMA CV. The default value is set to `Active`. The standard set of extra fields can be configured for this value.
Qualified Person Responsible for Pharmacovigilance (QPPV)	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Registration Status	The status of a registration can be Planned, Active, Pending, Expired, or Withdrawn.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.

EMA Authorization Status Attributes

To define an EMA authorization status value, enter values for the following attributes:


Attribute	Description
Authorization Status	Status of the authorisation/registration of a medicinal product.
Status Code	Authorisation status code associated with the selected Authorisation Status.
RMS Term Name	List of Active EMA Authorisation Status RMS Values must be available for selection.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

To define a medicinal product type value, enter values for the following attributes:


Attribute	Description
Medicinal Product Type Name	Authorization – medicinal product types container name.
Medicinal Product Type Code	Authorization – medicinal product types container code.
RMS Term Name	List of Active EMA Authorisation Status RMS Values available for selection.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

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	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

To define a registration status value, enter values for the following attributes:


Attribute	Description
Name	Name given for the Registration Status.
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	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.