Agenda of the CVMP meeting 9-11 September 2025
Submitted by Anonymous (not verified) on 8 September 2025 - 14:15
Agenda of the CVMP meeting 9-11 September 2025
Dossier administrative validation checklist for initial marketing authorisation applications by applicants
Submitted by Anonymous (not verified) on 8 September 2025 - 14:13
Dossier administrative validation checklist for initial marketing authorisation applications by applicants
PSUSA/00002359/202501
Submitted by Anonymous (not verified) on 8 September 2025 - 13:44
PSUSA/00002359/202501
Pre-authorisation guidance
Submitted by Anonymous (not verified) on 8 September 2025 - 13:35
Pre-authorisation guidance
Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application
Submitted by Anonymous (not verified) on 8 September 2025 - 13:33
Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Submitted by Anonymous (not verified) on 8 September 2025 - 13:32
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Submitted by Anonymous (not verified) on 8 September 2025 - 13:32
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
PSUSA/00002849/202411
Submitted by Anonymous (not verified) on 8 September 2025 - 10:38
PSUSA/00002849/202411
Global IDMP Working Group (GIDWG) Stakeholder Meeting: 1-3 October 2025, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 3 October 2025, 12:30 (CEST) to 3 October 2025, 14:00 (CEST)
Submitted by Anonymous (not verified) on 8 September 2025 - 9:51
Global IDMP Working Group (GIDWG) Stakeholder Meeting: 1-3 October 2025, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 3 October 2025, 12:30 (CEST) to 3 October 2025, 14:00 (CEST)
GIDWG Stakeholder Meeting: 1-3 October 2025, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 3 October 2025, 12:30 (CEST) to 3 October 2025, 14:00 (CEST)
Submitted by Anonymous (not verified) on 8 September 2025 - 9:51
GIDWG Stakeholder Meeting: 1-3 October 2025, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 3 October 2025, 12:30 (CEST) to 3 October 2025, 14:00 (CEST)