http://ema.europa.eu/fhir/CodeSystem/100000155688
type: CodeSystem
node role: treeRoot
id:
  v: 100000155688
meta:
  version id:
    v: 5.0.0
  last updated:
    v: 2023-08-03T11:35:00.198Z
text:
  status:
    v: generated
  div: Generated Narrative: CodeSystem 100000155688 version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000 This case-sensitive code system http://spor.ema.europa.eu/v1/lists/100000155688 defines the following codes: Code Display 100000155689 Initial Marketing Authorisation Application 100000155690 Variation Type IA 100000155691 Variation Type IAIN 100000155692 Variation Type IB 100000155693 Variation Type II 100000155694 National Variation 100000155695 Line Extension 100000155696 Periodic Safety Update Report 100000155697 Renewal 100000155698 Follow-up Measure 100000155699 Specific Obligation 100000155700 Active Substance Master File 100000155701 Plasma Master File 100000155702 Referral acc. Article 29, 30, 31, 35 or 107i 100000155703 Annual Reassessment 100000155704 Urgent Safety Restriction 100000155705 Paediatric Submission acc. Article 29 100000155706 Paediatric Submission acc. Article 46 100000155707 WHO Cooperation acc. Article 58 100000155708 Notification acc. Article 61(3) 100000155709 Transfer of a marketing authorisation 100000155710 Lifting of a Suspension 100000155711 Withdrawal 100000155712 Reformatting 100000155713 Risk Management Plan 100000155714 Correction to the Published Annexes 100000155715 Review of a Suspension of MA 100000155716 Supplemental Information 100000155717 Post-Authorisation Measure 100000155718 Periodic Safety Update Single Assessment 200000002290 Certificate of suitability application to EDQM 200000002291 Clinical data for publication – Final Version 200000002292 Clinical data for publication – Redacted Proposal 200000002293 Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006 200000002294 Paediatric investigational plan compliance check 200000002295 Paediatric investigational plan deferral 200000002296 Paediatric investigational plan submission (Module 1.10) 200000002297 Paediatric investigational plan partial waiver 200000002298 Paediatric investigational plan waiver 200000002299 Annex II condition r…
url:
  v: http://spor.ema.europa.eu/v1/lists/100000155688
version:
  v: 1.2.0
name:
  v: ApplicationSubmissionTypeCs
title:
  v: Application Submission Type
status:
  v: active
experimental:
  v: false
date:
  v: 2025-10-21T12:20:05+01:00
publisher:
  v: EMA
contact:
  name:
    v: EMA
  telecom:
    system:
      v: url
    value:
      v: https://support.ema.europa.eu/esc
description:
  v: Application Submission Type
case sensitive:
  v: true
content:
  v: complete
count:
  v: 103
concept:
  code:
    v: 100000155689
  display:
    v: Initial Marketing Authorisation Application
concept:
  code:
    v: 100000155690
  display:
    v: Variation Type IA
concept:
  code:
    v: 100000155691
  display:
    v: Variation Type IAIN
concept:
  code:
    v: 100000155692
  display:
    v: Variation Type IB
concept:
  code:
    v: 100000155693
  display:
    v: Variation Type II
concept:
  code:
    v: 100000155694
  display:
    v: National Variation
concept:
  code:
    v: 100000155695
  display:
    v: Line Extension
concept:
  code:
    v: 100000155696
  display:
    v: Periodic Safety Update Report
concept:
  code:
    v: 100000155697
  display:
    v: Renewal
concept:
  code:
    v: 100000155698
  display:
    v: Follow-up Measure
concept:
  code:
    v: 100000155699
  display:
    v: Specific Obligation
concept:
  code:
    v: 100000155700
  display:
    v: Active Substance Master File
concept:
  code:
    v: 100000155701
  display:
    v: Plasma Master File
concept:
  code:
    v: 100000155702
  display:
    v: Referral acc. Article 29, 30, 31, 35 or 107i
concept:
  code:
    v: 100000155703
  display:
    v: Annual Reassessment
concept:
  code:
    v: 100000155704
  display:
    v: Urgent Safety Restriction
concept:
  code:
    v: 100000155705
  display:
    v: Paediatric Submission acc. Article 29
concept:
  code:
    v: 100000155706
  display:
    v: Paediatric Submission acc. Article 46
concept:
  code:
    v: 100000155707
  display:
    v: WHO Cooperation acc. Article 58
concept:
  code:
    v: 100000155708
  display:
    v: Notification acc. Article 61(3)
concept:
  code:
    v: 100000155709
  display:
    v: Transfer of a marketing authorisation
concept:
  code:
    v: 100000155710
  display:
    v: Lifting of a Suspension
concept:
  code:
    v: 100000155711
  display:
    v: Withdrawal
concept:
  code:
    v: 100000155712
  display:
    v: Reformatting
concept:
  code:
    v: 100000155713
  display:
    v: Risk Management Plan
concept:
  code:
    v: 100000155714
  display:
    v: Correction to the Published Annexes
concept:
  code:
    v: 100000155715
  display:
    v: Review of a Suspension of MA
concept:
  code:
    v: 100000155716
  display:
    v: Supplemental Information
concept:
  code:
    v: 100000155717
  display:
    v: Post-Authorisation Measure
concept:
  code:
    v: 100000155718
  display:
    v: Periodic Safety Update Single Assessment
concept:
  code:
    v: 200000002290
  display:
    v: Certificate of suitability application to EDQM

code:
  v: 200000002291
display:
  v: Clinical data for publication – Final Version

code:
  v: 200000002292
display:
  v: Clinical data for publication – Redacted Proposal

code:
  v: 200000002293
display:
  v: Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006

code:
  v: 200000002294
display:
  v: Paediatric investigational plan compliance check

code:
  v: 200000002295
display:
  v: Paediatric investigational plan deferral

code:
  v: 200000002296
display:
  v: Paediatric investigational plan submission (Module 1.10)

code:
  v: 200000002297
display:
  v: Paediatric investigational plan partial waiver

code:
  v: 200000002298
display:
  v: Paediatric investigational plan waiver

code:
  v: 200000002299
display:
  v: Annex II condition related to a post-authorisation measure

code:
  v: 200000002300
display:
  v: Corrective Action/Preventive Action related to a post-authorisation measure

code:
  v: 200000002301
display:
  v: Legally binding measure related to a post-authorisation measure

code:
  v: 200000002302
display:
  v: Additional pharmacovigilance activity in the risk-management plan

code:
  v: 200000002303
display:
  v: Submission of a post-authorisation efficacy study

code:
  v: 200000002304
display:
  v: Additional pharmacovigilance activity in the risk-management plan

code:
  v: 200000002305
display:
  v: Recommendation related to a post-authorisation measure

code:
  v: 200000002306
display:
  v: Cumulative review following a request related to a post-authorisation measure

code:
  v: 200000002307
display:
  v: Specific obligation related to a post-authorisation measure

code:
  v: 200000002308
display:
  v: Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC).

code:
  v: 200000002309
display:
  v: Submission of a post-authorisation safety study protocol amendment (according article 107o Dir. 2001/83/EC)

code:
  v: 200000002310
display:
  v: Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC).

code:
  v: 200000002311
display:
  v: Referral under Article 107i Dir. 2001/83/EC

code:
  v: 200000002312
display:
  v: Referral under Article 16c (1c) Dir. 2001/83/EC

code:
  v: 200000002313
display:
  v: Referral under Article 16c(4) Dir. 2001/83/EC

code:
  v: 200000002314
display:
  v: Referral under Article 20 Reg (EC) 726/2004

code:
  v: 200000002315
display:
  v: Referral under Article 29(4) Dir. 2001/83/EC

code:
  v: 200000002316
display:
  v: Referral under Article 29(1) Dir. 2001/83/EC

code:
  v: 200000002317
display:
  v: Referral under Article 13 Commission Reg (EC) 1234/2008

code:
  v: 200000002318
display:
  v: Referral under Article 29 paediatric Reg (EC) 1901/2006

code:
  v: 200000002319
display:
  v: Referral under Article 30 Dir. 2001/83/EC

code:
  v: 200000002320
display:
  v: Referral under Article 31 Dir. 2001/83/EC

code:
  v: 200000002321
display:
  v: Referral under Article 35 Dir. 2001/83/EC

code:
  v: 200000002322
display:
  v: Referral under Article 5(3) Reg (EC) 726/2004

code:
  v: 200000002323
display:
  v: Repeat Use Procedure

code:
  v: 200000002324
display:
  v: Signal detection

code:
  v: 200000002325
display:
  v: no regulatory activity

code:
  v: 200000003166
display:
  v: Paediatric investigational plan partial deferral

code:
  v: 200000010405
display:
  v: Periodic Safety Update Follow Up

code:
  v: 200000010406
display:
  v: Sunset Clause

code:
  v: 200000010407
display:
  v: Parallel Import

code:
  v: 200000018451
display:
  v: Variation not requiring assessment

code:
  v: 200000018452
display:
  v: Variation requiring assessment (reduced timetable)

code:
  v: 200000018453
display:
  v: Variation requiring assessment (standard timetable)

code:
  v: 200000018454
display:
  v: Variation requiring assessment (extended timetable)

code:
  v: 200000025603
display:
  v: Registration Application

code:
  v: 200000025605
display:
  v: Parallel Trade

code:
  v: 200000026016
display:
  v: Variation Type II Art. 29

code:
  v: 200000026017
display:
  v: Variation Type IB unforeseen

code:
  v: 200000029922
display:
  v: Variation requiring assessment (I changes)

code:
  v: 200000043398
display:
  v: Article 82 Referral

code:
  v: 200000043399
display:
  v: Article 82 based on Art 129(3) Referral

code:
  v: 200000043400
display:
  v: Article 70(11) Referral

code:
  v: 200000043401
display:
  v: Article 54(8) Procedure

code:
  v: 200000043402
display:
  v: Article 130(4) Procedure

code:
  v: 200000043403
display:
  v: Article 141(1)(c) Opinion

code:
  v: 200000043404
display:
  v: Article 141(1)(e) Opinion

code:
  v: 200000043524
display:
  v: Paediatric Submission acc. Article 45

code:
  v: 200000043525
display:
  v: Article 141(1)(i) Scientific advice

code:
  v: 220000000041
display:
  v: Article 45 Referral

code:
  v: 220000000042
display:
  v: Article 18

code:
  v: 220000000043
display:
  v: PSU Single Assessment

code:
  v: 220000000044
display:
  v: Workshare

code:
  v: 220000000045
display:
  v: Grouped Variation

code:
  v: 220000000046
display:
  v: IG Variation

code:
  v: 220000000047
display:
  v: Old Type I Variation

code:
  v: 220000000048
display:
  v: Switch Conditional to Full

code:
  v: 220000000049
display:
  v: Old Article 22

code:
  v: 220000000050
display:
  v: Flu Strain Update

code:
  v: 220000000051
display:
  v: Pandemic Update

code:
  v: 220000000052
display:
  v: Old Notification

code:
  v: 220000000053
display:
  v: Old Type I Following Type II

code:
  v: 220000000054
display:
  v: Old 2PMF

code:
  v: 220000000076
display:
  v: Orphan Designation Application