Scientific and regulatory meetings
Table of contents
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List item
Work instructions for organisation of paediatric expert group meetings (PDF/144.48 KB)
Adopted
First published: 29/11/2012
Last updated: 29/11/2012
Legal effective date: 30/11/2012
WIN/H/3412 -
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Work instructions for handling of Article 29(1) referrrals to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) (60-day procedure) by the CMDh secretariat (including Article 13 re... (PDF/89.72 KB)
Adopted
First published: 31/08/2011
Last updated: 31/08/2011
Legal effective date: 30/08/2011
WIN/H/3339 -
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Standard operating procedure on the organisation of Name Review Group meetings (PDF/117.52 KB)
Adopted
First published: 18/04/2011
Last updated: 18/04/2011
Legal effective date: 15/04/2011
SOP/H/3213 -
List item
Standard operating procedure for evaluation of conflicts of interests of experts for involvement in Agency activities (PDF/168.22 KB)
Adopted
First published: 22/08/2006
Last updated: 10/07/2013
Legal effective date: 10/07/2013
SOP/EMEA/0040 -
List item
Standard operating procedure for preparation and publication of Committee for Orphan Medicinal Products monthly report (PDF/127.14 KB)
Adopted
First published: 15/10/2007
Last updated: 19/12/2011
Legal effective date: 20/12/2011
SOP/H/3018 -
List item
Standard operating procedure for the organisation of European Medicines Agency Human Scientific Committees’ Working Party meetings with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals’ Organisa... (PDF/214.45 KB)
Adopted
First published: 05/12/2007
Last updated: 18/02/2015
Legal effective date: 13/01/2015
SOP/H/3130 -
List item
Standard operating procedure for organisation and management of ENCePP plenary meetings (PDF/255.48 KB)
Adopted
First published: 18/11/2010
Last updated: 18/11/2010
Legal effective date: 18/11/2010
SOP/H/3358 -
List item
Work instructions for organisation of scientific-advice and protocol-assistance presubmission meetings (PDF/88.55 KB)
Adopted
First published: 01/07/2008
Last updated: 24/06/2013
Legal effective date: 24/06/2013
WIN/H/3035 -
List item
Work instructions for general dealings between SAWP secretariat and working parties, SAGs, committees and patients' organisations (PDF/83.94 KB)
Adopted
First published: 24/11/2009
Last updated: 24/11/2009
Legal effective date: 26/11/2009
WIN/H/3036 -
List item
Work instructions for maintenance of rapid-alert/non-urgent-information (RA/NUI) contact points list and fax machine for RA/NUI use (PDF/190.09 KB)
Adopted
First published: 05/12/2008
Last updated: 01/08/2011
Legal effective date: 29/07/2011
WIN/H/3150 -
List item
Work instructions for organisation of Scientific Advice Working Party meetings (medicines for human use) (PDF/125.89 KB)
Adopted
First published: 28/07/2008
Last updated: 11/06/2013
Legal effective date: 11/06/2013
WIN/H/3195
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List item
Standard operating procedure for evaluation procedure for CVMP MUMS/limited market classification requests (PDF/150.49 KB)
Adopted
First published: 26/01/2018
Last updated: 26/01/2018
Legal effective date: 22/01/2018
SOP/V/4111 -
List item
Work instructions for organisation of CVMP Working Party meetings (PDF/155.2 KB)
Adopted
First published: 05/01/2017
Last updated: 05/01/2017
Legal effective date: 15/12/2016
WIN/V/4029 -
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Work instructions for Committee for Medicinal Products for Veterinary Use (CVMP) press release procedure and publication of documents adopted by CVMP (PDF/134.5 KB)
Adopted
First published: 07/05/2015
Last updated: 07/05/2015
Legal effective date: 01/05/2015
WIN/V/4001 -
List item
Standard Operating Procedure for Requests for advice from CMD(v) to CVMP (PDF/31.33 KB)
Adopted
First published: 16/01/2008
Last updated: 16/01/2008
Legal effective date: 16/01/2008
SOP/V/4036 -
List item
Standard operating procedure for review and approval of VICH guidelines by CVMP and its working parties (PDF/148.98 KB)
Adopted
First published: 24/08/2009
Last updated: 02/09/2015
Legal effective date: 21/08/2015
SOP/V/4047