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Document type

Classifies the type of a referenced document (e.g. SmPC, labelling, PIL). Used as a keyword on a Context of Use.

eCTD 4.0 Document type 195 terms
HA Controlled Vocabulary Term Code Agency Status
EU Document type Medical Records
200000012466
EMA Active
EU PI Document Type Mock ups
100000155540
EMA Active
US Promotional Material Type Monograph
us_promo_material_type_16
FDA —
EU Document type Multiple document types
200000012479
EMA Active
EU Document type Necropsy report
200000012467
EMA Active
ICH Document Type nonstandard safety study?
ich_document_type_94
ICH Active
EU Document type Other
200000012468
EMA Active
US Promotional Material Type Other
us_promo_material_type_17
FDA —
ICH Document Type other data not specified
ich_document_type_42
ICH Active
EU PI Document Type Other Product Information
100000155537
EMA Active
EU PI Document Type Outer Packaging
100000155534
EMA Active
EU PI Document Type Package Leaflet
100000155538
EMA Active
EU PI Document Type Package Leaflet and Labelling
200000017121
EMA Active
Attached Document Type Packaging
756005040000003
SwissMedic —
Attached Document Type Patient Information
756005040000002
SwissMedic —
ICH Document Type patient reported outcomes
ich_document_type_33
ICH Active
ICH Document Type patients excluded from efficacy analysis
ich_document_type_19
ICH Active
ICH Document Type pbbm report?
ich_document_type_82
ICH Active
ICH Document Type pbpk report?
ich_document_type_81
ICH Active
ICH Document Type pd invitro study?
ich_document_type_88
ICH Active
ICH Document Type pd invivo study?
ich_document_type_87
ICH Active
US Promotional Material Type PDURS
us_promo_material_type_47
FDA —
ICH Document Type pharmacodynamics
ich_document_type_34
ICH Active
ICH Document Type pharmacogenomics
ich_document_type_35
ICH Active
ICH Document Type pharmacokinetics
ich_document_type_36
ICH Active

Showing 101–125 of 195 terms . Data sourced from public health authority publications and updated periodically.