Certification procedure

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Content of the dossier: For details Nathalie Vicente Andrew McMath 29/01/10 ©2010 EDQM, Council of Europe, All rights reserved
How it works: Application Up-dating : - at any change (minor/major) - After 5 years (renewal) Request for inspection Revision of monograph Transfer to EDQM experts group Validation Evaluation (2 assessors) + TAB if necessary CEP granted Possibility of hearing Request for add info refusal Info of licensing auth. Andrew McMath 29/01/10 ©2010 EDQM, Council of Europe, All rights reserved
Page 1 and 2: The Certification Procedure Dr. And
Page 3 and 4: Regulatory background Active substa
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: Assessors and Certification Divisio
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

Certification procedure

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