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 | N/A |
|
N/A | |
| Application Legal Basis | N/A |
|
N/A | |
| Application Submission Type | N/A |
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| Combination Package | N/A |
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||
| Combined Pharmaceutical Dose Form | N/A |
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| Combined Term | N/A |
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| Contact Party Role | N/A |
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| Country | N/A |
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| Data Classification | N/A | Confidentiality Indicator on the Global Detail Sets attribute page. | ||
| Domain | N/A |
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| EU Regulatory Authorisation Procedure | N/A |
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| Ingredient Role | N/A |
|
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| Language | N/A |
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| Legal Status for the Supply | N/A |
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| Manufacturing Activity | N/A |
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| Marketing Status | N/A |
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| Master File Type | N/A |
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| Material | N/A |
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| Medical Dictionary For Regulatory Activities | N/A |
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| Medicinal Product Name Part Type | N/A |
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| Organization | N/A | N/A |
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|
| Organization | N/A | N/A |
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|
| Organization | N/A | N/A |
|
|
| Packaging | N/A |
|
N/A | |
| Pharmaceutical Dose Form | N/A |
|
N/A | |
| Product Category | N/A |
|
N/A | |
| Product Cross Reference Type | N/A |
|
N/A | |
| Product Information Document Type | N/A |
|
N/A | |
| Quantity Operator | N/A |
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||
| Regulatory Entitlement Status | N/A |
|
N/A | |
| Regulatory Entitlement Type | N/A |
|
N/A | |
| Routes and Methods of Administration | N/A |
|
N/A | |
| Shelf Life Type | N/A |
|
N/A | |
| Special Precaution for Storage | N/A |
|
N/A | |
| Units of Measurement | N/A |
|
N/A | |
| Units of Presentation | N/A |
|
N/A | |
| XEVMPD Medical Devices | N/A |
|
N/A | |
| XEVMPD Medical Product Type | N/A |
|
N/A |
Mapping of RMS and OMS is facilitated by a new selection widget.