VTM Virtual Therapeutic 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)

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package

VTM AtenololTenormin ATM VMP Atenolol 100 mg / O AMP Tenormin 100 mg AMPP Tenormin 100 mg 28 tablets VMPP Atenolol 100 mg/O 3 – 5 x 7 units Example : Atenonol 100 mg 28 tablets

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Vertical Distincition

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Pharmaco- therapeutic level Vertical Distinction

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Pharmaco- therapeutic level Trade level Vertical Distinction

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Horizontal Distinction

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Active ingredient (or multiples) Horizontal Distinction

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Strength Horizontal Distinction Active ingredient (or multiples)

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Strength Pack Size Horizontal Distinction Active substance (or multiples)

Pack Size Aggregated One shot For 1 day For 2 to 4 days For 5 to 7 days For x weeks (multiples of days) Based on usual posology for the main indication for the main target group (usually an adult – of 70 kg-)

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual 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

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Five higher aggregations for the (actual) Medicinal Product Package

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package Three higher aggregrations for the Actual Medicinal Product

VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package VMPP Virtual Medicinal Product Package One higher aggregation for VMPP, VMP en ATM

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)

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

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

Medicinal Product Package MPP Active substance(s) (1 or more) Excipient(s) (1 or more) Higher aggregations BASIC ELEMENTS TO BE DESCRIBED

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

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

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)

Descriptive characteristics of the Basic Element : Excipient Primary Key CAS number (international database) Excipient_substance (entity)

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