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Submission Type

Type of regulatory submission / activity (e.g. initial, variation, renewal). Regionally defined.

eCTD 4.0 Submission Type 50 terms
All agencies EMA FDA SwissMedic
Term Code Agency Status
Initial Marketing Authorisation Application 100000155689 EMA Active
Variation Type IA 100000155690 EMA Active
Variation Type IAIN 100000155691 EMA Active
Variation Type IB 100000155692 EMA Active
Variation Type II 100000155693 EMA Active
National Variation 100000155694 EMA Active
Line Extension 100000155695 EMA Active
Periodic Safety Update Report 100000155696 EMA Active
Renewal 100000155697 EMA Active
Specific Obligation 100000155699 EMA Active
Active Substance Master File 100000155700 EMA Active
Plasma Master File 100000155701 EMA Active
Annual Reassessment 100000155703 EMA Active
Urgent Safety Restriction 100000155704 EMA Active
Paediatric Submission acc. Article 29 100000155705 EMA Active
Paediatric Submission acc. Article 46 100000155706 EMA Active
WHO Cooperation acc. Article 58 100000155707 EMA Active
Notification acc. Article 61(3) 100000155708 EMA Active
Transfer of a marketing authorisation 100000155709 EMA Active
Lifting of a Suspension 100000155710 EMA Active
Withdrawal 100000155711 EMA Active
Risk Management Plan 100000155713 EMA Active
Post-Authorisation Measure 100000155717 EMA Active
Periodic Safety Update Single Assessment 100000155718 EMA Active
Certificate of suitability application to EDQM 200000002290 EMA Active
Clinical data for publication – Final Version 200000002291 EMA Active
Clinical data for publication – Redacted Proposal 200000002292 EMA Active
Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006 200000002293 EMA Active
Annex II condition related to a post-authorisation measure 200000002299 EMA Active
Corrective Action/Preventive Action related to a post-authorisation measure 200000002300 EMA Active
Legally binding measure related to a post-authorisation measure 200000002301 EMA Active
Additional pharmacovigilance activity in the risk-management plan 200000002302 EMA Active
Submission of a post-authorisation efficacy study 200000002303 EMA Active
Recommendation related to a post-authorisation measure 200000002305 EMA Active
Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC). 200000002308 EMA Active
Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC). 200000002310 EMA Active
Referral under Article 107i Dir. 2001/83/EC 200000002311 EMA Active
Referral under Article 16c (1c) Dir. 2001/83/EC 200000002312 EMA Active
Referral under Article 16c(4) Dir. 2001/83/EC 200000002313 EMA Active
Referral under Article 20 Reg (EC) 726/2004 200000002314 EMA Active
Referral under Article 29(4) Dir. 2001/83/EC 200000002315 EMA Active
Referral under Article 29 paediatric Reg (EC) 1901/2006 200000002318 EMA Active
Referral under Article 30 Dir. 2001/83/EC 200000002319 EMA Active
Referral under Article 31 Dir. 2001/83/EC 200000002320 EMA Active
Referral under Article 35 Dir. 2001/83/EC 200000002321 EMA Active
Referral under Article 5(3) Reg (EC) 726/2004 200000002322 EMA Active
Repeat Use Procedure 200000002323 EMA Active
no regulatory activity 200000002325 EMA Active
Paediatric Submission acc. Article 46 200000043524 EMA Active
Article 18 220000000042 EMA Active

50 terms shown for EMA. Data sourced from public health authority publications and updated periodically.