Module 12 2019

The future is here: ISO IDMP

class FullModelAuthorisedMedicinalProductsConceptual Level

Medicines RegulatoryAgency (Organisation)

Manufacturing Operation

MedicinalProduct Classification

Country / Language

MarketingAuthorisationHolder (Organisation)

RegulatedDocument

MarketingAuthorisation Application

MedicinalProduct Name

Version

Interactant

Manufacturer /Establishment (Organisation)

Marketing Authorisation Procedure

Periodic Safety UpdateReport Submission

Undesirable Effects

Marketing Authorisation

Interactions

MedicinalProduct

MarketingStatus

Clinical Particulars

Contra-indications

Population Specifics

ShelfLife / Storage

Batch Identifier

PackagedMedicinal Product

DeviceBatch Identification

Therapeutic Indication

Other Therapy Specifics

Pharmaceutical Product

Device Nomenclature

DataCarrier Identifier

Device

Route of Administration

Package Item (Container)

Pharmaceutical Product Characteristics

Package (Component)

PhPIDSet

Other Characteristics

Manufactured Item

Ingredients

SpecifiedSubstance

Physical Characteristics

Substance

Strength

Reference Strength

• Draft implementation guide prepared by EMA and circulated to Implementation Group for consultation • Implementation by Mid 2022?

The Organisation for Professionals in Regulatory Affairs