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VCP

AMS - Change applications to amend packaging of ITNs PDF

Guideline/guidance

VCP

AMS - Updating Declared Manufacturing Sites for Existing VCPs PDF

Guideline/guidance

VCP

AMS supporting template - Checklists for raw data submission (excel spreadsheets) DOCX

Guideline/guidance

Recently Updated Documents

WHO BDBV EUL Public Report for Xpert Hemorrhagic Fever Panel, (EUL 14508-070-00)

WHO BDBV EUL Public Report for RealStar Filovirus Screen RT-PCR Kit 1.0, (EUL 14469-153-00)

WHO Prequalification of medical devices FAQs

PQDx_119 Reportable changes to WHO prequalified and EUL IVD & non-IVD Medical Devices

PQDx_121 Guidance Reportable Changes

WHO Technical Report Series Location

WHO Technical Report Series documents relating to development, production, distribution, inspection and quality control of medicines can be found in the guidelines section of the WHO web pages dealing with quality assurance of medicines. The guidelines most relevant to WHO medicines prequalification are listed and accessible on the WHO Technical Report Series page.