Module 12 2019

CombinedPharmaceuticalDoseForm

Referentials

Additional monitoring indicator

OrphanDesignationStatus

Classification System

Classification SystemValue

EMA will act as broker and will provide referential data services to EU network

DocumentType

Country

Language

LegalStatus of Supply

• EMA will host reference lists from different maintenance organisations (WHO, EDQM, MSSO, BFARM, etc) – EDQM: maintenance organisation for ISO IDMP 11239 (ph. forms, units of presentation, routes of administration, packaging) – BFARM: maintenance organisation for Units of Measurement (ISO IDMP 11240)

Authorisation Status

ProcedureType

ORGRole

Contact personRole

MarketingStatus

Riskof shortagesupply

Indication as "Disease/Symptom/Procedure"

Co-Morbidity

Intended Effect

• EMA will be a maintenance organisation for new lists where no maintenance organisation exists

AdministrableDoseForm

Unit of Presentation

Route ofAdministration

DeviceType (combinedmedicaldeviceATMP)

• Common process which requires industry and other parties to request term registration before regulatory submission

Ingredient Role

ReferenceStrength Substance

ReferenceStrength Specified Substance

Package Item (Container)Type

Translations done by NCAs

•

MaterialName

ComponentType

ComponentMaterial

• All organisations need to register legacy & specific terms with EMA

DeviceType

ManufacturedDoseForm

• This model provides for a global forum, but this aspect is yet to be discussed

Unit of Presentation

Manufactured Item Quantity

The Organisation for Professionals in Regulatory Affairs