Scientific and regulatory meetings procedures

Human

Work instructions for organisation of paediatric expert group meetings

AdoptedLegal effective date: 30/11/2012Reference Number: WIN/H/3412

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...

AdoptedLegal effective date: 30/08/2011Reference Number: WIN/H/3339

Standard operating procedure on the organisation of Name Review Group meetings

AdoptedLegal effective date: 15/04/2011Reference Number: SOP/H/3213

Standard operating procedure for evaluation of conflicts of interests of experts for involvement in Agency activities

AdoptedLegal effective date: 10/07/2013Reference Number: SOP/EMEA/0040

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

AdoptedLegal effective date: 20/12/2011Reference Number: SOP/H/3018

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...

AdoptedLegal effective date: 13/01/2015Reference Number: SOP/H/3130

Standard operating procedure for organisation and management of ENCePP plenary meetings

AdoptedLegal effective date: 18/11/2010Reference Number: SOP/H/3358

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

AdoptedLegal effective date: 29/07/2011Reference Number: WIN/H/3150

Veterinary

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

AdoptedLegal effective date: 22/01/2018Reference Number: SOP/V/4111

Work instructions for organisation of CVMP Working Party meetings

AdoptedLegal effective date: 15/12/2016Reference Number: WIN/V/4029Summary:

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.

Work instructions for Committee for Medicinal Products for Veterinary Use (CVMP) press release procedure and publication of documents adopted by CVMP

AdoptedLegal effective date: 01/05/2015Reference Number: WIN/V/4001Summary:

The purpose of this WIN is to define the process and responsibilities for developing the CVMP press release; highlighting all steps taken until subsequent publication of the press release and documents adopted by CVMP and distribution of the press release to stakeholders.

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

AdoptedLegal effective date: 16/01/2008Reference Number: SOP/V/4036

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

AdoptedLegal effective date: 21/08/2015Reference Number: SOP/V/4047