Data Administration Updates: SPOR Master Lists
Ennov InSight 7.1 includes changes related to SPOR Master Lists Data Administration Updates.
Data Administration Updates
The Data Administration section has been updated to include the changes for SPOR Master Lists.
SPOR Master Lists
SPOR is the European Medicines Agency's (EMA) Master Data Management service that complies with ISO Identification of Medicinal Products (IDMP). There are two sub sections of SPOR that have controlled vocabularies supported in
Ennov InSight
7.1:
- OMS (Organisation Management Services
- RMS (Referentials Management Services)
Ennov InSight
7.1 will maintain local master copies of the SPOR source lists for OMS and RMS. The following SPOR data value lists are supported:
- Anatomical Therapeutic Chemical Classification System – Human
- Application Legal Basis
- Application Submission Type
- Combination Package
- Combined Pharmaceutical Dose Form
- Combined Term
- Contact Party Role
- Country
- Data Classification
- Domain
- EU Regulatory Authorisation Procedure
- Ingredient Role
- Language
- Legal Status for the Supply
- Manufacturing Activity
- Marketing Status
- Master File Type
- Material
- Medical Dictionary For Regulatory Activities
- Medicinal Product Name Party Type
- Organization
- Packaging
- Pharmaceutical Dose Form
- Product Category
- Product Cross Reference Type
- Product Information Document Type
- Quantity Operator
- Regulatory Entitlement Status
- Regulatory Entitlement Type
- Routes and Methods of Administration
- Shelf Life Type
- Special Precaution for Storage
- Units of Measurement
- Units of Presentation
- XEVMPD Medical Devices
- XEVMPD Medicinal Product Type