Module 12 2019

Use of Structured Data

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

The Organisation for Professionals in Regulatory Affairs