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VTM Virtual Therapeuti c Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Introduction of a datamodel in the authentic source on medicines (Acknowledgements: NHS, DM+D)

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Page 1: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Introduction of a datamodel

in the authentic source on medicines

(Acknowledgements: NHS, DM+D)

Page 2: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Page 3: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTM

Atenolol Tenormin

ATM

VMPAtenolol

100 mg / O

AMPTenormin

100 mg

AMPPTenormin

100 mg 28 tablets

VMPPAtenolol 100 mg/O

3 – 5 x 7 units

Example : Atenonol 100 mg 28 tablets

Page 4: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Vertical Distincition

Page 5: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Pharmaco-therapeuticlevel

Vertical Distinction

Page 6: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Pharmaco-therapeuticlevel

Trade level

Vertical Distinction

Page 7: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Horizontal Distinction

Page 8: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Active ingredient (or multiples)

Horizontal Distinction

Page 9: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Strength

Horizontal Distinction

Active ingredient (or multiples)

Page 10: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Strength

Pack Size

Horizontal Distinction

Active substance (or multiples)

Page 11: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Pack Size Aggregated

One shot

For 1 day

For 2 to 4 days

For 5 to 7 days

For x weeks

(multiples of 7 + 6 days)

Based on usual posology for the main indication for the main target group (usually an adult – of 70 kg-)

Page 12: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Medicinal Product Package

Conditionement

Verpakking

INN-Cluster

Brandname (MP)

Tabel of content of repertorium

Link with more familiar concepts

Page 13: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Five higher aggregations for the (actual) Medicinal Product Package

Page 14: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

Three higher aggregrations for the Actual Medicinal Product

Page 15: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

VTMVirtual

Therapeutic Moeity

Actual Therapeutic

Moeity

ATM

VMPVirtual

Medicinal Product

AMPActual

Medicinal Product

AMPP

Actual Medicinal Product Package

VMPP

Virtual Medicinal Product Package

One higher aggregation for VMPP, VMP en ATM

Page 16: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Identifying Characteristics of Aggregations

1) Virtual therapeutic moiety (VTM)

Primary key (+ HYR code ?)

INN_clustername

Application_area (high level abstraction of dosage form and administration route)

2) Actual therapeutic moiety (ATM)

Primary key (+ secondary key to VTM)

Idem +

MAH (possibly + licence holder)

Page 17: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Identifying Characteristics of Aggregations (cont.)

3) Virtual Medicinal Product (VMP)

Primary Key (+ secondary key to VTM)

VTM +

Strength_Pharmaceutical_Form (source FAGG)

4) Actual Medicinal Product (AMP)

Primary Key (+secondary keys to VTM, ATM, VMP)

VMP +

Marketing Authorisation Holder (possibly + licence holder)

Unit Pharmaceutical form

Registration information

Page 18: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Identifying Characteristics of Aggregations (cont.)

5) Virtual Medicinal Product Package (VMPP)

VMP +

Pack_size_aggregated (thesaurus controlled)

6) Actual Medicinal Product Package (AMPP)

See : basic elements

Page 19: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Medicinal Product Package

MPP

Active substance(s)

(1 or more)

Excipient(s)

(1 or more)

Higher aggregations

BASIC ELEMENTS TO BE DESCRIBED

Page 20: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Tools to describe

Basic Elements

Entities

Collections of descriptive characteristics

• Mandatory or optional

• Controlled by thesaurus or not

• Referring to external database or web site or not

• Based on law/regulation or not

Page 21: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Examples of Entities

Registration information

Price information

Reimbursement information

Doping information

Active Ingredient

Excipient

Strength

Dosage Form

Administration route

Pack Size

Outer package

Inner Package

Device

Trade name

MAH

Page 22: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Descriptive characteristics of the Basic Element : Active substance

Primary Key

CAS number (international database)

Active ingredient (entity)

INN – base

Salt / Acid / Ester

Molecular weight (number x unit)

INN_cluster_name (thesaurus controlled)

Page 23: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Descriptive characteristics of the Basic Element : Excipient

Primary Key

CAS number (international database)

Excipient_substance (entity)

Page 24: VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package

Descriptive characteristics of the Basic Element : Actual Medicinal Product Package

Primary Key (+ secundary keys to 5 higher aggregations

Active ingredient (repetitive)

Excipient_substance (repetitive)

Pack Size (in pharmaceutical units, administration units, DDD)

Presentation_name

Outer package (from controlled thesaurus)

Inner Package (from controlled thesaurus)

Device (from controlled thesaurus)

Price information

Reimbursement information