reference medicinal product - TOPRA

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Planning your Strategy: Choice of Procedure, Legal Basis and Achieving Agency Agreement Dan Sullivan Registration Manager Mylan www.mylan.com daniel.sullivan@mylan.co.uk 2
Scope and Learning Objectives » Legal basis of application » Routes to approval – the procedures » Sources of agency objections » how to anticipate / address these » Potential Serious Risk to Public Health and Referrals » Conclusions 3
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 44 and 45: Potential Serious Risks to Public H
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
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reference medicinal product - TOPRA

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