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 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 200000002304 Additional pharmacovigilance activity in the risk-management plan 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 protocol amendment (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 200000010405 Periodic Safety Update Follow Up 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 200000029922 Variation requiring assessment (I changes) 200000043398 Article 82 Referral 200000043399 Article 82 based on Art 129(3) Referral 200000043400 Article 70(11) Referral 200000043401 Article 54(8) Procedure 200000043402 Article 130(4) Procedure 200000043403 Article 141(1)(c) Opinion 200000043404 Article 141(1)(e) Opinion 200000043524 Paediatric Submission acc. Article 45 200000043525 Article 141(1)(i) Scientific advice 220000000041 Article 45 Referral 220000000042 Article 18 220000000043 PSU Single Assessment 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
Initial Marketing Authorisation Application
Referral acc. Article 29, 30, 31, 35 or 107i
Periodic Safety Update Single Assessment
Certificate of suitability application to EDQM
Clinical data for publication – Final Version
Clinical data for publication – Redacted Proposal
Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006
Paediatric investigational plan compliance check
Paediatric investigational plan deferral
Paediatric investigational plan submission (Module 1.10)
Paediatric investigational plan partial waiver
Annex II condition related to a post-authorisation measure
Corrective Action/Preventive Action related to a post-authorisation measure
Legally binding measure related to a post-authorisation measure
Additional pharmacovigilance activity in the risk-management plan
Submission of a post-authorisation efficacy study
Recommendation related to a post-authorisation measure
Cumulative review following a request related to a post-authorisation measure
Specific obligation related to a post-authorisation measure
Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC).
Submission of a post-authorisation safety study protocol amendment (according article 107o Dir. 2001/83/EC)
Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC).
Referral under Article 107i Dir. 2001/83/EC
Referral under Article 16c (1c) Dir. 2001/83/EC
Referral under Article 16c(4) Dir. 2001/83/EC
Referral under Article 20 Reg (EC) 726/2004
Referral under Article 29(4) Dir. 2001/83/EC
Referral under Article 29(1) Dir. 2001/83/EC
Referral under Article 13 Commission Reg (EC) 1234/2008
Referral under Article 29 paediatric Reg (EC) 1901/2006
Referral under Article 30 Dir. 2001/83/EC
Referral under Article 31 Dir. 2001/83/EC
Referral under Article 35 Dir. 2001/83/EC
Referral under Article 5(3) Reg (EC) 726/2004
Paediatric investigational plan partial deferral
Variation requiring assessment (reduced timetable)
Variation requiring assessment (standard timetable)
Variation requiring assessment (extended timetable)
Variation requiring assessment (I changes)