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:

English (EN) (144.48 KB - PDF)

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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:

English (EN) (89.72 KB - PDF)

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Standard operating procedure on the organisation of Name Review Group meetings

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

English (EN) (117.52 KB - PDF)

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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:

English (EN) (127.14 KB - PDF)

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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:

English (EN) (214.45 KB - PDF)

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Standard operating procedure for organisation and management of ENCePP plenary meetings

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

English (EN) (255.48 KB - PDF)

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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:

English (EN) (190.09 KB - PDF)

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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:

English (EN) (150.49 KB - PDF)

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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.

English (EN) (155.2 KB - PDF)

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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:

English (EN) (31.33 KB - PDF)

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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:

English (EN) (148.98 KB - PDF)

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