reference medicinal product - TOPRA

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Potential Serious Risks to Public Health (PSRPH) » Only reason why a MS can refuse to recognise application » Definition provided in 2006/C 133/05 of March 2006. » Limited number and variety of objections that can be raised to: » Efficacy, Safety, Quality » Overall risk-benefit » Product Information » Objection must be scientifically justified and not rely solely on a national requirement or viewpoint. 44
Major hurdles for generic applications » SmPC disharmony » Due to not harmonised originator SmPC » Compromises required – differences originator/generic » Marketing impact? » Bioequivalence » Wrong strategy » Wrong study design » Wrong comparator » Legal basis » RMS and CMS may not agree
Page 2 and 3: Planning your Strategy: Choice of P
Page 4 and 5: Where to start? Data Exclusivity Ho
Page 6 and 7: Legal Definition of a Generic Gener
Page 8 and 9: Reference Medicinal Product » MA A
Page 10 and 11: Same qualitative and quantitative c
Page 12 and 13: The legal basis of your application
Page 14 and 15: Article 10 Applications » Art 10(1
Page 16 and 17: Article 10(1) - Generics » ... the
Page 18 and 19: Article 10(a) - Well-established us
Page 20 and 21: National Application » One applica
Page 22 and 23: MR procedure - MRP Phase Day 0 to 5
Page 24 and 25: Review of Legislation 2001 - Outcom
Page 26 and 27: MR procedure post-Oct 2005 National
Page 28 and 29: CMDh - 60-day procedure » Results
Page 30 and 31: The DeCentralised Procedure - Summa
Page 32 and 33: QUESTION All member states act equa
Page 34 and 35: DCP - obtaining (and keeping) your
Page 36 and 37: DCP - Assessment Step I Day 0 Day 7
Page 38 and 39: DCP - Assessment Step I Day 106 Day
Page 40 and 41: DCP - No consensus reached Day 210
Page 42 and 43: Centralised Procedure » Single app
Page 46 and 47: Preparing your response » Make sur
Page 48 and 49: Which procedure can I use? » Natio
Page 50 and 51: Which procedure is quickest? (on pa
Page 52 and 53: Which procedure is cheapest? 52
Page 54 and 55: Approval to Launch Marketing Author
Page 56 and 57: Scope and Learning Objectives » Le
Page 58: Questions? 58

reference medicinal product - TOPRA

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