RMS Terms

Use Referentials Management Services (RMS) terms to include referential master data for attributes of medicinal products such as lists of dosage forms, units of measurement and routes of administration.

RMS allows you to map a SPOR Term with the Data Administration values. The following table shows the Data Administration value and the SPOR value it is linked to.


Data Administration Function	Data Administration Value	SPOR Master List Name
Product Family Maintenance	— ATC Values — Domain	— Anatomical Therapeutic Chemical classification system - Human — Domain — EU Regulatory Authorisation Procedure
Other	— Legal Basis Values — Application Submission Type — Language Values — Indications/Intended Use Values — Units of Measurement — Unit of Presentation Values — Concentration Measure Type Values — Attached Document Content Type Values — Source of Information Values	— Application Legal Basis — Application Submission Type — Language — Medical Dictionary For Regulatory Activities — Units of Measurement — Units of Presentation — Quantity Operator — eCTD EU Context of Use, Product Information Document Type, Regulating Authority Submission Unit Type — Source of Information
Product Maintenance	— Dosage/Pharmaceutical Form — Product Category — Product Cross Reference Type — Routes of Administration Values — Medical Device Values	— Combination Package — Combined Pharmaceutical Dose Form — Combined Term — Pharmaceutical Dose Form — Product Category — Product Cross Reference Type — Routes and Methods of Administration — XEVMPD Medical Devices


Data Administration Function	Data Administration Value	SPOR Master List Name
Registration Maintenance	— Marketing Status — Master File Type — Regulatory Entitlement Status — Provenance Reason — Registration Status Values — Data Carrier Type Values — Data Carrier Identifier Source	— Marketing Status — Master File Type — Medicinal Product Name Part Type — Regulatory Entitlement Status — XEVMPD Medical Product Type — Regulatory Entitlement Status — Source of Information
Application Maintenance	— Country Values — Procedure Type Values — Legal Status Values — Regulatory Entitlement Type — Product Information Document Type — Medicinal Product Name Part Type — Medicinal Product Type Values	— Country — Legal Status for the Supply — Regulatory Entitlement Type — Product Information Document Type — Medicinal Product Name Part Type — XEVMPD Medical Product Type
Product Detail Set Maintenance	— Substance Type Values — Manufacturing Function Values — Material Values — Packaging Type Value — Shelf Life Type Values — Storage Condition Values — Manufacturer Values Global Detail Sets — Component Type — Medical Device UDI — Device - Type of Combination — Time Unit Values — Intended Effect	— Ingredient Role — Manufacturing Activity — Material — Packaging — Shelf Life Type — Special Precaution for Storage — Units of Measurement — Medical Device Legislative Category — Container Category — Medicine Profile
Data Administration Function	Data Administration Value	SPOR Master List Name
Medical Device Maintenance	Device Classification Values	Medical Device Classification

Associate RMS Terms with Data Administration Entities

You can map a RMS term with the Data Administration values using the RMS tab available on the Data

Administration values attributes page.

Only one RMS term can be associated to the Data Administration value. Associating another term will replace the existing term.

To associate RMS Terms:

On the homepage, click Go To > Data Administration.
Navigate to the Data Administration entities and click the link for the Data Administration value.
Example

Example: Application Maintenanace > Country Values
Click the country to which you want to associate the term.
On the Country page, select RMS tab.
Click Associate Term
The Term Search window populates the Term fields.
Select the Term on the Search Results box and click Associate Term.

Disassociate RMS Terms with Data Administration Entities

You can disassociate a RMS term from the Data Administration values using the disassociate icon available on the RMS tab of the Data Administration values attributes page.

To disassociate RMS Terms:

Navigate to the Data Administration entities and click the link for the Data Administration value. For Example: Application Maintenanace > Country Values
Click the country from which you want to disassociate the term.
On the Country page, select RMS tab:
Select the Term, Click Disassociate Term .

RMS Terms Attributes

The following are the RMS Terms attributes and their description:


Attribute	Description
Term Id	Term Identifier from the SPOR values.
Term Name	Term Name from the SPOR values.


Attribute	Description
ISO Code	The ISO code for the term, if applicable.
xEVMPD Code	The XEVMPD code for the term, if applicable.
Source Mapping Code	Source Mapping Code for the RMS list values.