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

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CodeSystem: Application Submission Type

Official URL: http://spor.ema.europa.eu/v1/lists/100000155688 Version: 1.0.0
Active as of 2025-04-04 Computable Name: ApplicationSubmissionTypeCs

Application Submission Type

This Code system is referenced in the content logical definition of the following value sets:

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:

CodeDisplay
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
100000155713 Risk Management Plan
100000155714 Correction to the Published Annexes
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 related to a post-authorisation measure
200000002300 Corrective Action/Preventive Action related to a post-authorisation measure
200000002301 Legally binding measure related to a post-authorisation measure
200000002302 Additional pharmacovigilance activity in the risk-management plan
200000002303 Submission of a post-authorisation efficacy study
200000002305 Recommendation related to a post-authorisation measure
200000002306 Cumulative review following a request related to a post-authorisation measure
200000002307 Specific obligation related to a post-authorisation measure
200000002308 Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC).
200000002309 Submission of a post-authorisation safety study report (according article 107o Dir. 2001/83/EC)
200000002310 Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC).
200000002311 Referral under Article 107i Dir. 2001/83/EC
200000002312 Referral under Article 16c (1c) Dir. 2001/83/EC
200000002313 Referral under Article 16c(4) Dir. 2001/83/EC
200000002314 Referral under Article 20 Reg (EC) 726/2004
200000002315 Referral under Article 29(4) Dir. 2001/83/EC
200000002316 Referral under Article 29(1) Dir. 2001/83/EC
200000002317 Referral under Article 13 Commission Reg (EC) 1234/2008
200000002318 Referral under Article 29 paediatric Reg (EC) 1901/2006
200000002319 Referral under Article 30 Dir. 2001/83/EC
200000002320 Referral under Article 31 Dir. 2001/83/EC
200000002321 Referral under Article 35 Dir. 2001/83/EC
200000002322 Referral under Article 5(3) Reg (EC) 726/2004
200000002323 Repeat Use Procedure
200000002324 Signal detection
200000002325 no regulatory activity
200000003166 Paediatric investigational plan partial deferral
200000010406 Sunset Clause
200000010407 Parallel Import
200000018451 Variation not requiring assessment
200000018452 Variation requiring assessment (reduced timetable)
200000018453 Variation requiring assessment (standard timetable)
200000018454 Variation requiring assessment (extended timetable)
200000025603 Registration Application
200000025605 Parallel Trade
200000026016 Variation Type II Art. 29
200000026017 Variation Type IB unforeseen
220000000041 Article 45 Referral
220000000042 Old Article 18
220000000044 Workshare
220000000045 Grouped Variation
220000000046 IG Variation
220000000047 Old Type I Variation
220000000048 Switch Conditional to Full
220000000049 Old Article 22
220000000050 Flu Strain Update
220000000051 Pandemic Update
220000000052 Old Notification
220000000053 Old Type I Following Type II
220000000054 Old 2PMF
220000000076 Orphan Designation Application