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 |
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 |