R RegData
← eCTD Controlled Vocabularies

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 43 terms
All agencies EMA FDA ICH SwissMedic
Term Code Agency Status
Summary of Product Characteristics 100000155532 EMA Active
Annex II 100000155533 EMA Active
Outer Packaging 100000155534 EMA Active
Labelling 100000155535 EMA Active
Immediate Packaging 100000155536 EMA Active
Other Product Information 100000155537 EMA Active
Package Leaflet 100000155538 EMA Active
Combined File of all Documents 100000155539 EMA Active
Mock ups 100000155540 EMA Active
Appendix V 100000155541 EMA Active
Analysis 200000012457 EMA Active
Article 200000012458 EMA Active
Certificate 200000012459 EMA Active
Cytology report 200000012460 EMA Active
Echocardiogram 200000012461 EMA Active
Histopathology report 200000012462 EMA Active
Labeling Materials 200000012463 EMA Active
Laboratory Report 200000012464 EMA Active
Letter 200000012465 EMA Active
Medical Records 200000012466 EMA Active
Necropsy report 200000012467 EMA Active
Other 200000012468 EMA Active
Photograph 200000012469 EMA Active
Product Label 200000012470 EMA Active
QA Report 200000012471 EMA Active
Radiographs 200000012472 EMA Active
Record 200000012473 EMA Active
Sonogram 200000012474 EMA Active
Specification 200000012475 EMA Active
Computer Tomography 200000012476 EMA Active
Investigation report 200000012477 EMA Active
Magnetic Resonance Imaging 200000012478 EMA Active
Multiple document types 200000012479 EMA Active
Promotional Material 200000012480 EMA Active
Package Leaflet and Labelling 200000017121 EMA Active
Specimens 200000027914 EMA Active
List of all authorised presentations (Annex A) 200000027915 EMA Active
Restrictions posed by Member States (Annex 127a) 200000027916 EMA Active
Application Form 200000051362 EMA Active
Tracking Table 200000051363 EMA Active
Application Form Annexes 200000051364 EMA Active
Response 200000051920 EMA Active
Additional data 200000051921 EMA Active

43 terms shown for EMA. Data sourced from public health authority publications and updated periodically.