PDF-JuneEMEA/5542/02/Rev Human Medicines Evaluation DivisionThe linguistic

Author : danika-pritchard | Published Date : 2016-10-27

At submission and during assessment only the English language version EN of the product information is submitted and reviewed see section 21 147preopinion148 Applicants

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JuneEMEA/5542/02/Rev Human Medicines Evaluation DivisionThe linguistic: Transcript

At submission and during assessment only the English language version EN of the product information is submitted and reviewed see section 21 147preopinion148 Applicants may provide a c. 4420 74 18 84 00 Fax 4420 74 18 84 09 Email mailemeaeuropaeu httpwwwemeaeuropaeu EMEA 2008 Reproduction andor distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London 11 December 2007 CPMP 4420 74 18 84 00 Fax 4420 74 18 85 45 Email mailemeaeuropaeu http wwwem eaeuropaeu EMEA 2007 Reproduction andor distribution of this document is authoris ed for non commercial purposes only provided the EMEA is acknowledged London 19 July 2007 Doc R 4420 74 18 84 00 Fax 4420 75 23 70 51 Email mailemeaeuropaeu httpwwwemeaeuropaeu EMEA 2007 Reproduction andor distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London 26 October 2006 Doc R GUIDELINE ON THE LIMITS OF GENOTOXIC IMPURITIES DISCUSSION IN THE SAFETY WORKING PARTY DEADLINE FOR COMMENTS DISCUSSION IN THE SAFETY WORKING PARTY AND QUALITY WORKING PARTY June 2003 - February (CHMP) GUIDELINE ONTHE CHOICE OF THE NON-INFERIORITY MARGIN DRAFT AGREED BY THE EFFICACY WORKING PARTY ADOPTION BY COMMITTEE FOR RELEASE FOR CONSULTATION February 2004 AGREED BY WORKING PARTY June (CHMP) SEALANT/HAEMOSTATIC PRODUCTS (CPMP/BPWG/153/00) DISCUSSION IN THE BLOOD PRODUCTS WORKING GROUP DISCUSSION IN THE PHARMACOVIGILANCE WORKING PARTY April 2001 TRANSMISSION TO THE CPMP Decembe EMEA/CHMP/BMWP/31329/2005 Page 2/6 EMEA 2006 TABLE OF CONTENTS EXECUTIVE SUMMARY...................................................................................................................3 GUIDELINE ON THE LIMITS OF GENOTOXIC IMPURITIES DISCUSSION IN THE SAFETY WORKING PARTY DEADLINE FOR COMMENTS DISCUSSION IN THE SAFETY WORKING PARTY AND QUALITY WORKING PARTY June 2003 - February (COMMITTEE ABBREVIATION) GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS DRAFT AGREED BY BWP May 2006 ADOPTION BY CHMPFOR RELEASE FOR CONSULTATION 28 Ju COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON DECLARATION OF HERBAL SUBSTANCES AND HERBAL PREPARATIONS IN HERBAL MEDIC Page 2 of 7 EMEA 2005 TABLE OF CONTENTS 1. INTRODUCTION.....................................................................................................................3 1.1 R Page 2 of 7 EMEA 2005 TABLE OF CONTENTS 1 INTRODUCTION3 11 Regulatory framework3 12 Scope3 13 Need to issue guidance on this emerging issue3 14 Purpose3 2 BASIC PRINCIPLES3 21 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE EVALUATION OF THE PHARMACOKINETICS OF MEDICINAL PRODUCTS IN PATIENTS WITH IMPAIRED HEPATIC DISCUSSION IN THE EFFICACY WORKIN th. January 2021 . Steve Williams. Lead Clinical Pharmacist PrescQIPP Practice Plus. Agenda. Time. Title. Presenter. 12.45. Welcome , introduction and reflections . STOP, THINK, RE-FOCUS. Steve Williams .

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