Ennov InSight Registrations 7.3

XEVMPD Data Administration Sections Correspondence

As a data administrator, you are responsible for setting up and maintaining the data available in selection lists in Calyx RIM.

The following tables represent the different Data Administration section groupings in correspondence to XEVMPD (Extended EudraVigilance Medicinal Product Dictionary).

Table 1. Application Maintenance
Data Administration Section Groupings/Functionalities XEVMPD
Procedure Type Values
Table 2. Other
Data Administration Section Groupings/Functionalities XEVMPD
Concentration Measure Type Values
Denominator Unit Values
Indications/Intended Use Values
Language Values
Legal Basis Values
MAH/Development Sponsor/Organization Values
Master File Location (MFL) Values
Message Sender Values
Numerator Unit Values
Previous EV Code Values
SME Status Values
Unit of Measure Prefix Values
Table 3. Product Detail Set Maintenance
Data Administration Section Groupings/Functionalities XEVMPD
Compendial Designation/Source Values
Substance Role Values
Manufacturer Values
Substance Type Values
Table 4. Product Family Maintenance
Data Administration Section Groupings/Functionalities XEVMPD
ATC Values
Substance Attachment Values
Substance Class Values
Substance Values
Table 5. Product Maintenance
Data Administration Section Groupings/Functionalities XEVMPD
Dosage/Pharmaceutical Form Values
Medical Device Values
Route of Administration Values
Table 6. Registration Maintenance
Data Administration Section Groupings/Functionalities XEVMPD
EMA Authorization Status Values
Medicinal Product Type Values
Qualified Person Responsible for Pharmacovigilance (QPPV) Values