SPOR Mapping to Ennov InSight 7.1 Data Administration Lists

To support mapping EMA SPOR terms to Ennov InSight value lists, new RMS and OMS tabs are added to applicable value lists.

Name of the SPOR Master List in Ennov InSight Existing Ennov InSight Value List Mapping NewEnnov InSight Value List Mapping New RMS Tab with Fields New OMS Tab with Fields
Anatomical Therapeutic Chemical Classification System – Human Product Family > ATC Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Application Legal Basis Other > Legal Basis Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Application Submission Type N/A Other > Application Submission Type Values
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Combination Package Product Maintenance > Dosage/Pharmaceutical Form Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Combined Pharmaceutical Dose Form Product Maintenance > Dosage/Pharmaceutical Form Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Combined Term Product Maintenance > Dosage/Pharmaceutical Form Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Contact Party Role Registration Maintenance > Qualified Person Responsible for Pharmacovigilance (QPPV) Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Country Application Maintenance > Country Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Data Classification Product Detail Set Maintenance > Manufacturer Values – Global Detail Sets N/A Confidentiality Indicator on the Global Detail Sets attribute page.
Domain N/A Product Family Maintenance > Domain Type Values
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
EU Regulatory Authorisation Procedure Application Maintenance > Procedure Type Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Ingredient Role Product Detail Set Maintenance > Substance Role Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Language Other > Language Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Legal Status for the Supply Application Maintenance > Legal Status Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Manufacturing Activity Product Detail Set Maintenance > Manufacturing Function Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Marketing Status Registration Maintenance > Marketing Status Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Master File Type N/A Registration Maintenance > Master File Type Values
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Material Product Detail Set Maintenance > Product Material Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Medical Dictionary For Regulatory Activities Other > Indications/Intended Use Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Medicinal Product Name Part Type N/A Registration Maintenance > Medicinal Product Name Part Type Values
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Organization Other > MAH/Development Sponsor/Organisation Values N/A N/A
  • Organization ID
  • Location ID
  • Organization
  • Name
  • Address
  • City
  • Post Code
  • Country
  • Last User Updated
  • Last Changed Date
  • Active Flag
Organization Product Detail Set Maintenance > Manufacturer Values N/A N/A
  • Organization ID
  • Location ID
  • Manufacturer
  • Name
  • Address
  • City
  • Post Code
  • Country
  • Last User Updated
  • Last Changed Date
  • Active Flag
Organization Application Maintenance > Country Values - Health Authority N/A N/A
  • Organization ID
  • Location ID
  • Health Authority
  • Name
  • Address
  • City
  • Post Code
  • Country
  • Last User Updated
  • Last Changed Date
  • Active Flag
Packaging Product Detail Set Maintenance > Packaging Type Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Pharmaceutical Dose Form Product Maintenance > Dosage/Pharmaceutical Form Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Product Category N/A Product Maintenance > Product Category Values
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Product Cross Reference Type N/A Product Maintenance > Product Cross Reference Type Values
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Product Information Document Type N/A Application > Product Information Document Type
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Quantity Operator Other > Concentration Measure Type Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
Regulatory Entitlement Status N/A Application Maintenance > Orphan Status Values
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Regulatory Entitlement Type N/A Application Maintenance > Regulatory Entitlement Type Values
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Routes and Methods of Administration Product Maintenance > Routes of Administration Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Shelf Life Type Product Detail Set Maintenance > Shelf Life Type Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Special Precaution for Storage Product Detail Set Maintenance > Storage Condition Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Units of Measurement N/A Other > Units of Measurement Values
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
Units of Presentation Other > Unit of Presentation Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
XEVMPD Medical Devices Product Maintenance > Medical Device Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A
XEVMPD Medical Product Type Registration Maintenance > Medicinal Product Type Values N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
N/A

Mapping of RMS and OMS is facilitated by a new selection widget.