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
| Official URL: http://ema.europa.eu/fhir/vs/applicationSubmissionType | Version: 1.2.1 | |||
| Active as of 2026-06-26 | Computable Name: ApplicationSubmissionTypeVs | |||
Application Submission Type
References
Expansion performed internally based on codesystem Application Submission Type v1.2.1 (CodeSystem)
This value set contains 103 concepts
| System | Code | Display (en) | JSON | XML |
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155689 | Initial Marketing Authorisation Application | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155690 | Variation Type IA | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155691 | Variation Type IAIN | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155692 | Variation Type IB | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155693 | Variation Type II | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155694 | National Variation | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155695 | Line Extension | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155696 | Periodic Safety Update Report | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155697 | Renewal | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155698 | Follow-up Measure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155699 | Specific Obligation | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155700 | Active Substance Master File | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155701 | Plasma Master File | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155702 | Referral acc. Article 29, 30, 31, 35 or 107i | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155703 | Annual Reassessment | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155704 | Urgent Safety Restriction | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155705 | Paediatric Submission acc. Article 29 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155706 | Paediatric Submission acc. Article 46 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155707 | WHO Cooperation acc. Article 58 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155708 | Notification acc. Article 61(3) | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155709 | Transfer of a marketing authorisation | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155710 | Lifting of a Suspension | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155711 | Withdrawal | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155712 | Reformatting | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155713 | Risk Management Plan | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155714 | Correction to the Published Annexes | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155715 | Review of a Suspension of MA | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155716 | Supplemental Information | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155717 | Post-Authorisation Measure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 100000155718 | Periodic Safety Update Single Assessment | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002290 | Certificate of suitability application to EDQM | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002291 | Clinical data for publication – Final Version | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002292 | Clinical data for publication – Redacted Proposal | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002293 | Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002294 | Paediatric investigational plan compliance check | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002295 | Paediatric investigational plan deferral | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002296 | Paediatric investigational plan submission (Module 1.10) | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002297 | Paediatric investigational plan partial waiver | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002298 | Paediatric investigational plan waiver | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002299 | Annex II condition related to a post-authorisation measure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002300 | Corrective Action/Preventive Action related to a post-authorisation measure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002301 | Legally binding measure related to a post-authorisation measure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002302 | Additional pharmacovigilance activity in the risk-management plan | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002303 | Submission of a post-authorisation efficacy study | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002304 | Additional pharmacovigilance activity in the risk-management plan | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002305 | Recommendation related to a post-authorisation measure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002306 | Cumulative review following a request related to a post-authorisation measure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002307 | Specific obligation related to a post-authorisation measure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002308 | Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC). | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002309 | Submission of a post-authorisation safety study protocol amendment (according article 107o Dir. 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002310 | Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC). | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002311 | Referral under Article 107i Dir. 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002312 | Referral under Article 16c (1c) Dir. 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002313 | Referral under Article 16c(4) Dir. 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002314 | Referral under Article 20 Reg (EC) 726/2004 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002315 | Referral under Article 29(4) Dir. 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002316 | Referral under Article 29(1) Dir. 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002317 | Referral under Article 13 Commission Reg (EC) 1234/2008 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002318 | Referral under Article 29 paediatric Reg (EC) 1901/2006 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002319 | Referral under Article 30 Dir. 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002320 | Referral under Article 31 Dir. 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002321 | Referral under Article 35 Dir. 2001/83/EC | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002322 | Referral under Article 5(3) Reg (EC) 726/2004 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002323 | Repeat Use Procedure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002324 | Signal detection | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000002325 | no regulatory activity | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000003166 | Paediatric investigational plan partial deferral | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000010405 | Periodic Safety Update Follow Up | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000010406 | Sunset Clause | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000010407 | Parallel Import | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000018451 | Variation not requiring assessment | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000018452 | Variation requiring assessment (reduced timetable) | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000018453 | Variation requiring assessment (standard timetable) | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000018454 | Variation requiring assessment (extended timetable) | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000025603 | Registration Application | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000025605 | Parallel Trade | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000026016 | Variation Type II Art. 29 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000026017 | Variation Type IB unforeseen | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000029922 | Variation requiring assessment (I changes) | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000043398 | Article 82 Referral | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000043399 | Article 82 based on Art 129(3) Referral | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000043400 | Article 70(11) Referral | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000043401 | Article 54(8) Procedure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000043402 | Article 130(4) Procedure | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000043403 | Article 141(1)(c) Opinion | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000043404 | Article 141(1)(e) Opinion | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000043524 | Paediatric Submission acc. Article 45 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 200000043525 | Article 141(1)(i) Scientific advice | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000041 | Article 45 Referral | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000042 | Article 18 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000043 | PSU Single Assessment | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000044 | Workshare | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000045 | Grouped Variation | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000046 | IG Variation | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000047 | Old Type I Variation | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000048 | Switch Conditional to Full | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000049 | Old Article 22 | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000050 | Flu Strain Update | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000051 | Pandemic Update | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000052 | Old Notification | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000053 | Old Type I Following Type II | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000054 | Old 2PMF | ||
http://spor.ema.europa.eu/v1/lists/100000155688 | 220000000076 | Orphan Designation Application |
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 |