PDF-10 NovemberEMA/CHMP/SAWP/72894/2008Revision 1: January 2012Revision 2:

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Adoption by CHMPfor release for consultation24 April 2008 End of consultation deadline for comments30 June 2008 Final Agreed by CHMP22 January 2009 Keywords EMA

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10 NovemberEMA/CHMP/SAWP/72894/2008Revision 1: January 2012Revision 2:: Transcript

Adoption by CHMPfor release for consultation24 April 2008 End of consultation deadline for comments30 June 2008 Final Agreed by CHMP22 January 2009 Keywords EMA CHMP Novel methodology Q ualifica. europaeu Website wwwemaeuropaeu European Medicines Agency 2014 Reproduction is authorised provided the source is ac knowledged Guideline on similar biological medicinal products containing biotechnology derived proteins as active substance quality Our audit of the retailer network disclosed the following deficiencies x The Lottery was defi FLHQW57347LQ57347UHTXHVWLQJ57347WKH57347UHWDLOHUV5752657347SHUVRQDO57347FUHGLW57347UHSRUW5735957347SODFLQJ57347UHWDLOHUV on probation and requiring deposit Adoption by CHMP for release for consultation24 May 2012 Start of public consultation31 May 2012 End of consultation (deadline for comments)30 November 2012 Revised draft agreed by BMWP and BWPApril 2 memberships in the CHMP and CVMP. Renewed memberships include also those memberships where 7 Westferry Circus Canary Wharf London E14 4HB United KingdomAn agency of the European Union Telephone Cou EMEA/CHMP/QWP/49313/2005 Corr EMEA 2006 Page 2/27 GUIDELINE ON THE PHARMACEUTICAL QUALITY OF INHALATION AND NASAL PRODUCTS TABLE OF CONTENTS 1. INTRODUCTION........................................ (CHMP) REFLECTION PAPER ON METHODOLOGICAL ISSUES IN CONFIRMATORY CLINICAL TRIALS PLANNED WITH AN ADAPTIVE DESIGN DRAFT AGREED BY THE EFFICACY WORKING PARTY 11 January 2006 ADOPTION BY CHMP FOR REL 30 07/11/201411/13/2008Revision:Supersedes Revision:07/21/2014Printed: * Key wordGHS hazard phraseAspiration Toxicity, Category 1DangerAquatic Toxicity (Acute), Category 3noneAquatic Toxicity (Chronic Adoptedby CHMPfor release for consultation art of public consultation13 May 2015 End of consultation (deadline for comments)November 2015 7 This guideline replaces 'Guideline on clinical devel Adoption by CHMP for release for consultationOctober 2011 End of consultation (deadline for comments)31 March 2012 Agreed by BMWPJanuary Date for coming into effect01 September 2013 Interferon beta, (CHMP) GUIDELINE ON STRATEGIES TO IDENTIFY AND MITIGATE RISKS FOR FIRST-IN- HUMAN CLINICAL TRIALS WITH INVESTIGATIONAL MEDICINAL PRODUCTS DRAFT AGREED BY CHMP EXPERT GROUP 6 March 2007 ADOPTION BY 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 Adoptedby CHMPfor release for consultation20 March 2014Start of public consultation28 April201End of consultation deadline for commentsJuComments should be provided using this template The completed c Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how - to - find - us Send us a qu the meeting). EURORDIS . Open Academy . 05 June 2024, Barcelona. Presented by Janina Karres, Scientific Officer, Orphan Medicines Office, EMA. PART 1. Application for orphan designation (OD). 1. Orphan designation (OD).

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