EMA Write PMS API Implementation Guide - Enrichments
1.2.1 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

ValueSet: Master File Type + DocumentType

Official URL: http://ema.europa.eu/fhir/vs/masterFileTypeAndDocumentType Version: 1.2.1
Active as of 2026-06-26 Computable Name: MasterFileTypeAndDocumentTypeVs

Master File Type + DocumentType

References

This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

Logical Definition (CLD)

This value set includes codes based on the following rules:

 

Expansion

This value set contains 21 concepts

SystemCodeDisplay (en)JSONXML
http://spor.ema.europa.eu/v1/lists/100000155531  100000155532Summary of Product Characteristics
http://spor.ema.europa.eu/v1/lists/100000155531  100000155533Annex II
http://spor.ema.europa.eu/v1/lists/100000155531  100000155534Outer Packaging
http://spor.ema.europa.eu/v1/lists/100000155531  100000155535Labelling
http://spor.ema.europa.eu/v1/lists/100000155531  100000155536Immediate Packaging
http://spor.ema.europa.eu/v1/lists/100000155531  100000155537Other Product Information
http://spor.ema.europa.eu/v1/lists/100000155531  100000155538Package Leaflet
http://spor.ema.europa.eu/v1/lists/100000155531  100000155539Combined File of all Documents
http://spor.ema.europa.eu/v1/lists/100000155531  100000155540Mock ups
http://spor.ema.europa.eu/v1/lists/100000155531  100000155541Appendix V
http://spor.ema.europa.eu/v1/lists/100000155531  200000017121Package Leaflet and Labelling
http://spor.ema.europa.eu/v1/lists/100000155531  200000027914Specimens
http://spor.ema.europa.eu/v1/lists/100000155531  200000027915List of all authorised presentations (Annex A)
http://spor.ema.europa.eu/v1/lists/100000155531  200000027916Restrictions posed by Member States (Annex 127a)
http://spor.ema.europa.eu/v1/lists/220000000070  220000000071Pharmacovigilance System Master File
http://spor.ema.europa.eu/v1/lists/220000000070  220000000072Active Substance Master File
http://spor.ema.europa.eu/v1/lists/220000000070  220000000073Contract Research Organisation Master File
http://spor.ema.europa.eu/v1/lists/220000000070  220000000074Plasma Master File
http://spor.ema.europa.eu/v1/lists/220000000070  220000000075Vaccine/Antigen Master File
http://spor.ema.europa.eu/v1/lists/220000000070  220000026003Certificate of Suitability for Transmissible Spongiform Encephalopathies
http://spor.ema.europa.eu/v1/lists/220000000070  220000026004Certificate of Suitability

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code