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Marketing Authorization In The Eu
- 1. Virgilio Vinas, MD, MPH, PhD. Universitat Autonoma de Barcelona Pierre-Marie Curie Paris-V
- 5. Structure of the Common Technical Document (CTD))
- 20. Efficacy (Clinical Documentation) Deficiency letter to applicant / oral discussion if necessary Applicant‘s Response Document Phase 2 = Evaluation of the response document Quality, Toxicology-Pharmacology, Clinic Decision on the application National Procedure National committee/board Marketing Authorization Pre-submission meeting for the MRP ‚ Scientific Advice‘ Pre-submission meeting
- 32. Pre-submission Phase 1 Clock Stop Phase 2 Opinion Decision Post Authorization Day 0• -----------------Start of procedure Day 80--------------- -Rapporteur/Co-Rapporteur’s Assessment Reports Day 100--------------- Comments of CHMP member States / experts Day 120----------------Adoption of the consolidated List of Questions) (Q, S, E, SPC, Labelling, PIL)
- 41. Applicant submits dossier Validation Concerned Member States Day 0 - 50 - Evaluation of assessment report and experts reports (and dossier) - Quality (Chemical, Pharmaceutical and Biological Documentation) - Safety ( Toxicological-Pharmacological Documentation) - Efficacy (Clinical Documentation) -Comments/Objections to Reference Member State and Applicant Applicants Response Document Evaluation of the response document Day 75 Break out session /discussion Day 90 Decision on the application EU-MSs National authorities/agencies Marketing authorization Applicant submits national texts