Scientific and regulatory meetings procedures

Human

Work instructions for organisation of paediatric expert group meetings

AdoptedReference Number: WIN/H/3412Legal effective date: 30/11/2012

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...

AdoptedReference Number: WIN/H/3339Legal effective date: 30/08/2011

Standard operating procedure on the organisation of Name Review Group meetings

AdoptedReference Number: SOP/H/3213Legal effective date: 15/04/2011

Standard operating procedure for preparation and publication of Committee for Orphan Medicinal Products monthly report

AdoptedReference Number: SOP/H/3018Legal effective date: 20/12/2011

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...

AdoptedReference Number: SOP/H/3130Legal effective date: 13/01/2015

Standard operating procedure for organisation and management of ENCePP plenary meetings

AdoptedReference Number: SOP/H/3358Legal effective date: 18/11/2010

Work instructions for maintenance of rapid-alert/non-urgent-information (RA/NUI) contact points list and fax machine for RA/NUI use

AdoptedReference Number: WIN/H/3150Legal effective date: 29/07/2011

Veterinary

Standard operating procedure for evaluation procedure for CVMP MUMS/limited market classification requests

AdoptedReference Number: SOP/V/4111Legal effective date: 22/01/2018

Work instructions for organisation of CVMP Working Party meetings

AdoptedReference Number: WIN/V/4029Legal effective date: 15/12/2016Summary:

The WIN applies to the Veterinary Medicines Division and in particular to the assistants who are responsible for the organisation and distribution of mailings for the relevant CVMP Working Party.

Standard Operating Procedure for Requests for advice from CMD(v) to CVMP

AdoptedReference Number: SOP/V/4036Legal effective date: 16/01/2008

Standard operating procedure for review and approval of VICH guidelines by CVMP and its working parties

AdoptedReference Number: SOP/V/4047Legal effective date: 21/08/2015