Module 12 2019

ISO IDMP = BIG!!!

class Full Model Authorised Medicinal Products Conceptual Level

Medicines Regulatory Agency (Organisation) Manufacturin g and Supply

Manufacturing Operation

Medicinal Product Classification

Country / Language

Marketing Authorisation Holder (Organisation)

Regulated Document

Product Information

Marketing Authorisation Application

Medicinal Product Name

Version

Interactant

Manufacturer /Establishment (Organisation)

Marketing Authorisation Procedure

Periodic Safety Update Report Submission

Undesirable Effects

Marketing Authorisation

Interactions

Medicinal Product

Marketing Status Registration

Clinical Particulars

Contra-indications

Population Specifics

Other Therapy Specifics Clinical and Safety

Shelf Life / Storage

Batch Identifier

Packaged Medicinal Product

Device Batch Identification

Therapeutic Indication

Pharmaceutical Product

Device Nomenclature

Data Carrier Identifier

Device

Route of Administration

Package Item (Container)

Pharmaceutical Product Characteristics

Package (Component)

PhPID Set Product Definition

Other Characteristics

Production

Manufactured Item

Ingredients

Specified Substance

Physical Characteristics

Substance

Strength

Reference Strength

Substance

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