Scientific and regulatory meetings procedures

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Human

Work instructions for organisation of paediatric expert group meetings

Adopted Reference Number: WIN/H/3412 Legal effective date:

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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...

Adopted Reference Number: WIN/H/3339 Legal effective date:

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Standard operating procedure on the organisation of Name Review Group meetings

Adopted Reference Number: SOP/H/3213 Legal effective date:

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

Adopted Reference Number: SOP/H/3018 Legal effective date:

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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...

Adopted Reference Number: SOP/H/3130 Legal effective date:

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Standard operating procedure for organisation and management of ENCePP plenary meetings

Adopted Reference Number: SOP/H/3358 Legal effective date:

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

Adopted Reference Number: WIN/H/3150 Legal effective date:

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Veterinary

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

Adopted Reference Number: SOP/V/4111 Legal effective date:

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Work instructions for organisation of CVMP Working Party meetings

Adopted Reference Number: WIN/V/4029 Legal effective date: Summary:

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.

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

Adopted Reference Number: SOP/V/4036 Legal effective date:

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

Adopted Reference Number: SOP/V/4047 Legal effective date:

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