SPOR Master Lists

The SPOR Master Lists section in Ennov InSight Data Administration is designed to maintain the European Medicines Agency (EMA) Substance, Product, Organization, and Referential (SPOR) service.

To facilitate the reliable exchange of Medicinal Product information the European Medicines Agency (EMA) introduced Substance, Product, Organization, and Referential (SPOR) program.

According to the roadmap designed by EMA the SPOR support starts with an introduction of OMS and RMS components:

— OMS - Organizations management service. OMS manages organization master data, including organization name and location address, for organizations such as marketing authorization holders (MAH), sponsors, regulatory authorities, and manufacturers.

— RMS - Referentials management service. RMS manages the referential master data. In Ennov InSight it is included to the Data Administration > SPOR Master Lists section as lists of values used to describe the attributes of a medicinal product. For example: dosage forms, units of measure, and routes of administration (ROA).

When you select a value under SPOR Master List, a page opens with a table of all values that have been defined. You can sort these values by column, define the number of values to be displayed on the page, or export the table data to Excel.

Set Data Administration to Yes in the Security Administration > Home Page Access section to be able to access the SPOR Master Lists values.

SPOR Master Lists Values

You can add and modify RMS Value lists and set the status of a value to active or inactive from Data Administration > SPOR Master Lists.

The following RMS Values are included to the SPOR Master Lists section in Data Administration. The table view display name is a combination of the value name and the appropriate SPOR System Referentials List from which the value is derived.


Value	Description
Anatomical Therapeutic Chemical Classification System - Human	The Anatomical Therapeutic Chemical Classification System Human table is introduced to provide the ATC code as indicated as Pharmacodynamic properties of the corresponding SmPC regulatory authority.
Application Legal Basis	A classification value of a medicinal product.
Application Submission Type	The type of marketing authorization application that is described using the term id.
Combination Package	The pharmaceutical form that is submitted for authorizations or is authorized by the regulatory authorities. These details are reflected in the regulatory documents. Combination package of the combined pharmaceutical form, when two or more manufactured dose forms are intended to be combined to create a single administrable dose form.
Combined Pharmaceutical Dose Form	The pharmaceutical form is submitted for authorizations or as authorised by regulatory authorities. These details are reflected in the regulatory documents. A combined pharmaceutical form is used when two or more manufactured dose forms are intended to be combined to create a single administrable dose form.
Combined Term	The combined term for the medicinal products.
Contact Party Role	The type of contact in the context of the Medicinal Product must be specified.
Container Category	The names of specific containers or categories to manage and classify various referential data such as ingredient names, dosage forms, and route of administration to provide their proper use and consistency.
Country	The country where the medicinal product name has been authorized.


Value	Description
Data Classification	The Data Classification is a RMS list and is used to populate the Confidentiality Indicator field available on the Data Administration > Manufacturer Values > Global Detail Sets Attributes page.
Domain	The Domain describes whether the type of medicinal product is for human or for veterinary use.
ECTD EU Context of Use	The ECTD EU Context of Use is used to place documents under a CTD heading and associated keywords in accordance with EU requirements.
EU Regulatory Authorisation Procedure	The regulatory procedure applied to grant or amend a marketing authorization for a Medicinal Product.
Ingredient Role	The role of the active ingredient as part of the manufactured item/ pharmaceutical product.
Language	The language of the medicinal product name for the specified country, as approved by the regulatory authority.
Legal Status for the Supply	The legal status of supply of the medicinal product as authorized by the relevant competent authority.
Manufacturing Activity	The manufacturer of the active substance (including active substance manufacturers). You must specify the solvent/adjuvant for combined pharmaceutical forms from the list of manufacturers based on the resource Marketing Status.
Marketing Status	The marketing status of the medicinal products.
Master File Type	Indicates the type of master file.
Material	The material(s) within a package. This Material RMS list is mapped to the Data Administration > Product Detail Set Maintenance > Product Materials Values .
Medical Device Classification	The classification for medical devices that has an impact on the confirmity assesment procedures to place the device on European market.
Medical Device Legislative Category	Category to determine the intended purpose of the devices and their inherent risks.
Medical Dictionary For Regulatory Activities	Standardized medical terminology to facilitate sharing of regulatory information.
Medicinal Product Name Part Type	The medicinal product name parts must be specified along with the language of the country and as per the marketing authorization that is applied in accordance with the referenced SmPC.


Value	Description
Medicinal Product Type	The categorization of medicinal products based on their characteristics and intended use.
Medicine Profile	The detailed information about the medicine or drug. Medicine profile provides the healthcare specialists with essential information to ensure the effective use of a medicine.
Organization (OMS)	The organizations and locations from the EMA Organization Management Services (OMS).
Packaging	The packaging of the medicinal products.
Pharmaceutical Dose Form	The manufactured dose form is described with the authorized pharmaceutical form(s). Pharmaceutical Form of the SmPC or other regulatory document.
Product Category	The product classification.
Product Cross Reference Type	The cross-reference types used to reduce submission size and lessen redundancies.
Product Information Document Type	The type of the contact must be specified in the context of the Medicinal Product.
Quantity Operator	To provide the strength of the substance ingredient(s) contained in the medicinal product, the corresponding quantity operator is selected. The quantity operator applies to each of the below data elements: — Strength Presentation — Strength Concentration
Reason for Marketing Unavailability	The factors that influence the product availability in the market.
Regulatory Entitlement Status	The status of the marketing authorization.
Regulating Authority Submission Unit Type	A type of a document to submit for regulatory assessment.
Regulatory Entitlement Type	The type of regulatory authorization.
Routes and Methods of Administration	Routes and Methods of Authorization.
Shelf Life Type	Shelf life types such as the shelf life of the Packaged Medicinal Product itself, shelf-life after transformation, etc.
Source of Information	Different types of information categorized based on its format and purpose.
Value	Description
Special Precaution for Storage	Special precautions for storage of the packaged medicinal products.
Substance	Substance Management Services (SMS) terms to associate existing substance data to uniquely identify the ingredients and materials of a medicinal product. See the Functionality and Technology Not Supported section in Ennov InSight 7.2 Release Notes.
Terminology System List	A compilation of inventory of various terminology systems to organize and standardize the language, concepts and information relevant to particular discipline.
Units of Measurement	The strength (quantitative composition) of the substances (including active substances, ingredients, solvents, adjuvant as applicable) must be specified in this field with a numerator and denominator.
Units of Presentation	The strength (quantitative composition) of the substances (including active substances, ingredients, solvents, adjuvant as applicable) must be specified in this field with a numerator and denominator.
XEVMPD Medical Devices	Details of the XEVMPD Medical Devices.
XEVMPD Medicinal Product Type	Details of the XEVMPD medicinal product type.
Reason for Marketing Unavailability	Indicates the reason for the drug unavailability in the market. You cannot create/modify the respective value and its attributes.


Attribute	Description
Active Flag	The active flag for the term in the RMS list from the RMS Details.
Comments	The comments of the term in the RMS list from the RMS Details.
Creation Date	Defines when the values are added, either via automated updates from the EMA or manually by Data Administration users. By default, this option is read-only. It is populated automatically when updates are made to the table.
Default Flag	The default flag for the term in the RMS list from the RMS Details.
Description	The description of the term in the RMS list from the RMS Details.
Domain	The Domain of the term in the RMS list from the RMS Details. Human use or Veterinary use.
List Id	The list identifier for the RMS list from the RMS Summary.
List Name	The List Name for the RMS list from the RMS Summary.

The following table describes the OMS Value attributes.


Attribute	Description
List Owner	The List Owner for the RMS list from the RMS Summary. Examples are EMA, EDQM, WHO CC, MSSO.
Mapping Source	The Source Identifier for the term in the RMS list from the RMS Details.
Modification Date	The modification date and time for when the term was updated. Used to compare to the Modified on date in the Ennov InSight database to determine if the row has changed since it was last retrieved by Ennov InSight .
Modified On	The modified on date from operational attributes for the term in the RMS list from the RMS Details.
ISO Code	The ISO Code for the term in the RMS list from the RMS Details.
Short Name	The shortened name of a specific RMS Value, for example its abbreviation. Short Name is a text field. The Short Name from the SPOR System.
Source Term Id	The Source Term Identifier for the term in the RMS list from the RMS Details.
Status	The status assigned to a specific RMS Value. Status Type is a dropdown field with the following values available for selection: — Active (the specific RMS Value has been created and is in Active state) — Current (the specific RMS Value has been approved for the further use) — Inactive (the specific RMS Value is in Inactive state) — Non Current (the specific RMS Value has not been approved for the further use) — Nullified (the specific RMS Value has been published in error and needs to be removed) — Provisional (this specific RMS Value is created after validation by EMA, but prior to the approval)
Term Id	The term identifier from the SPOR System. The concatenation of the Term Name and Term Identifier values must be unique within the specific RMS List.
Term Name	The name of a term to which this specific RMS Value belongs. Term Name is a required field. The concatenation of the Term Name and Term Identifier values must be unique within the specific RMS List. The Term Name from the SPOR System.
Attribute	Description
XEVMPD Code	The XEVMPD code for the term in the RMS list from the RMS Details.
Version Number	The version number of the term in the RMS list from the RMS Details.
Created By	Defines by whom the values are added, either via automated updates from the EMA or manually by Data Administration users. By default, this option is read-only. It is populated automatically when updates are made to the table.
Last User Updated	Indicates the name of the user who last created/updated the value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

The following is the list of attributes used for defining an organization.


Attribute	Description
Location ID	The location identifier.
Organization ID	The organization identifier.
Name	The name of the organization.
Status	The status of organization. Example: Active or Inactive.
Created On	The date on which the organization entity is created
Modified On	The date on which the organization entity is modified
Is Headquarters	Indicates if the location is a headquarter.
XEVMPD Code	The XEVMPD code for the location.
Address 1	Address 1 of the organization
Address 2	Address 2 of the organization
Address 3	Address 3 of the organization
Address 4	Address 4 of the organization
City	The city of the organization
County	The county of the organization
Region	The region of the organization.
Attribute	Description
Postal Code	The postal code for the location of the organization.
GPS Location	The GPS location information of the organization.
Default Flag	The default flag for the location. Example: "Yes" or "No". By default, "No" is selected.
Active Flag	Indicates if the organization is active.
Creation Date	The creation date when the location was added to the Ennov InSight database.
Modification Date	The modification date and time for when the term was updated. Used to compare to the Modified on date in the Ennov InSight database to determine if the row has changed since it was last retrieved by Ennov InSight .
Activate/Deactivate	Activate or deactivate to determine the availability of an organization.

The following table describes RMS Value attributes.


Attribute	Description
List ID	The list identifier for the RMS list from the RMS summary.
List Name	The list name for the RMS list from the RMS summary.
List Owner	The list owner for the RMS list from the RMS summary. Examples: EMA, EDQM, WHO CC, and MSSO.
Term Id	The term identifier for term in the RMS list from the RMS details.
Term Name	The term name for the term in the RMS list from the RMS details.
Short Name	The short name for the term in the RMS list from the RMS Details.
Status	The status of the term in the RMS list from the RMS details.
Domain	The domain of the term in the RMS list from the RMS details. Human use or veterinary use.
Modified On	The date when the data was modified for the term in the RMS list from the RMS details.
Mapping Source	The mapping source identifier for the term in the RMS list from the RMS details.
Source Term Id	The source term identifier for the term in the RMS list from the RMS details.
XEVMPD Code	The XEVMPD code for the term in the RMS list from the RMS Details.
Description	The description of the term in the RMS list from the RMS details.
Comments	The comments of the term in the RMS list from the RMS details.