Module 12 2019

IDMP Data Model

class Full Model Authorised Medicinal Products Conceptual Level

Medicines RegulatoryAgency (Organisation)

Manufacturing Operation

Medicinal Product Classification

Country / Language

Marketing Authorisation Holder (Organisation)

Regulated Document

• RIM

Marketing Authorisation Application

Medicinal Product Name

Version

Interactant

Manufacturer /Establishment (Organisation)

solution

Marketing Authorisation Procedure

• DMS • eCTD

Periodic Safety Update Report Submission

Undesirable Effects

Marketing Authorisation

Interactions

Medicinal Product

Marketing Status

Clinical Particulars

• PV/ICSR • CT-data

Contra-indications

Population Specifics

Shelf Life / Storage

Batch Identifier

Packaged Medicinal Product

Device Batch Identification

Therapeutic Indication

Other Therapy Specifics

Pharmaceutical Product

• ERP • MES • LIMS

Device Nomenclature

Data Carrier Identifier

Device

Route of Administration

Package Item (Container)

Pharmaceutical Product Characteristics

Package (Component)

PhPID Set

Other Characteristics

Manufactured Item

Ingredients

Specified Substance

Physical Characteristics

Substance

Strength

Reference Strength

The Organisation for Professionals in Regulatory Affairs