XEVMPD Data Administration Sections Correspondence

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

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

Table 11. Table 1. Application Maintenance

Data Administration Section Groupings/Functionalities XEVMPD
Procedure Type Values

Table 12. 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 13. Table 3. Product Detail Set Maintenance

Data Administration Section Groupings/Functionalities XEVMPD
Compendial Designation/Source Values
Substance Role Values

| 12 - XEVMPD Data Administration Sections Correspondence | 164

Table 13. Table 3. Product Detail Set Maintenance (continued)

Data Administration Section Groupings/Functionalities XEVMPD
Manufacturer Values
Substance Type Values

Table 14. Table 4. Product Family Maintenance

Data Administration Section Groupings/Functionalities XEVMPD
ATC Values
Substance Attachment Values
Substance Class Values
Substance Values

Table 15. Table 5. Product Maintenance

Data Administration Section Groupings/Functionalities XEVMPD
Dosage/Pharmaceutical Form Values
Medical Device Values
Route of Administration Values

Table 16. 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