Certification procedure

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Summary • Place of <strong>Certification</strong> as a regulatory tool • Comparison of CEP & ASMF • How it works • How to read & use a CEP • Key figures • Recent developments Andrew McMath 29/01/10 ©2010 EDQM, Council of Europe, All rights reserved
Regulatory background Active substances in marketing applications : Directive 2003/63/EC and the various quality guidelines give options on how to fulfil the same basic requirements. The information required is the same regardless of the route selected (CEP or ASMF or Marketing Application) Andrew McMath 29/01/10 ©2010 EDQM, Council of Europe, All rights reserved
Page 1: The Certification Procedure Dr. And
Page 5 and 6: NfG CHMP/QWP/297/97 rev. 1 corr “
Page 7 and 8: Differences between CEP & ASMF - Sp
Page 9 and 10: Advantages of the CEP Provides: •
Page 11 and 12: Useful background • Notes for gui
Page 13 and 14: Out of Scope of the Certification p
Page 15 and 16: Steering Committee • Representati
Page 17 and 18: Assessors and Certification Divisio
Page 19 and 20: How it works: Application Up-dating
Page 21 and 22: HOW TO READ A CEP Andrew McMath 29/
Page 23 and 24: The CEP, TSE : • Certifies that t
Page 25 and 26: And as necessary, chemical CEPs:
Page 27 and 28: And for a TSE certificate: • Coun
Page 29 and 30: How to use a CEP: Andrew McMath 29/
Page 31 and 32: KEY FIGURES Andrew McMath 29/01/10
Page 33 and 34: Certificates of Suitability … > 5
Page 35 and 36: Recent developments 1. New procedur
Page 37 and 38: Recent developments 3. Substances e
Page 39: Thank you ! ☺ Andrew McMath 29/01

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