WHO Declaration of Manufacturing Sites docx
WHO Declaration of Product Formulation docx
WHO Emergency Use Listing for in vitro diagnostics (IVDs) detecting SARS-CoV-2 pdf
WHO EUAL Amended Public Report for Ebola IVD: Product: FilmArray Biothreat-E EUAL number: EAE 0433-154-00 pdf
WHO EUAL Amended Public Report for Ebola IVD: Product: Liferiver™ ‒ Ebola Virus (EBOV) Real Time RT-PCR Kit number: EAE 0432-139-00 pdf
WHO EUAL Amended Public Report for Ebola IVD: Product: STANDARD™ Q Ebola Zaire Ag EUAL number: EAE 0444-117-00 pdf
WHO EUAL Delisting: Product: ReEBOVTM Antigen Rapid Test Kit EUAL number: EA 0011-011-00 pdf
WHO EUAL Public Report for Ebola IVD: Product: OraQuick® Ebola Rapid Antigen Test Kit (cadaveric oral fluid and whole blood) EUAL number: EA 0023-021-00 pdf
WHO EUAL Public Report for Ebola IVD: Product: RealStar® Filovirus Screen RT-PCR Kit 1.0 Application number: EAE 0425-153-00 pdf
WHO EUAL Public Report for Ebola IVD: Product: Xpert Ebola Assay EUAL number: EAE 0443-070-00 pdf
WHO EUAL Public Report for Zika IVD: Product: AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit EUAL number: EAZ 0006-004-00 pdf
WHO EUAL Public Report for Zika IVD: Product: careGENETM Zika Virus RT-PCR kit WHO EUAL reference number: EAZ 0009-007-00 pdf
WHO EUAL Public Report for Zika IVD: Product: Liferiver Zika Virus (ZIKV) Real Time RT-PCR Kit WHO EUAL reference number: EAZ 0004-003-00 pdf
WHO EUAL Public Report for Zika IVD: Product: RealStar® Zika Virus RT-PCR Kit 1.0 EUAL number: EAZ 0003-002-00 pdf
WHO EUL Public Report for 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based) EUL Number: EUL 0576-221-00 pdf
WHO EUL Public Report for Abbott Panbio COVID-19 Ag Rapid Test Device (NASAL) EUL Number: EUL-0587-032-00 pdf
WHO EUL Public Report for COVID-19 IgM/IgG Test Kit (Colloidal Gold) EUL Number: EUL 0573-231-00 pdf
WHO EUL Public Report for COVID-19 IgM/IgG test kit (Rare earth nano fluorescence immunochromatography) EUL Number: EUL 0574-231-00 pdf
WHO EUL Public Report for Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) EUL Number: EUL 0588-238-00 pdf
WHO EUL Public Report for Panbio COVID-19 Ag Rapid Test Device (NASAL) EUL Number: 0587-032-00 pdf
WHO EUL Public Report for Panbio COVID-19 Ag Rapid Test Device EUL Number: EUL-0564-032-00 pdf
WHO EUL Public Report for QuantuMDx SARS-CoV-2 RT-PCR Detection Assay EUL Number: EUL 0570-229-00 pdf
WHO EUL Public Report for SARS CoV 2 Ag Diagnostic Test Kit (Colloidal Gold) EUL Number: EUL 0612-246-00 pdf
WHO EUL Public Report for SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) EUL Number: EUL 0582-223-00 pdf
WHO EUL Public Report for SARS-CoV-2 Antigen Test Kit (GICA) EUL Number: EUL 0621-250-00 pdf
WHO EUL Public Report for SARS-CoV-2: 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit EUL Number: EUL 0555-221-00 pdf
WHO EUL Public Report for SARS-CoV-2: Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody (Magnetic particle CLIA) EUL Number: EUL 0565-219-00 pdf
WHO EUL Public Report for SARS-CoV-2: Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification- Real Time Fluorescence Assay) EUL Number: EUL 0522-208-00 pdf
WHO EUL Public Report for SARS-CoV-2: Diagnovital SARS-CoV-2 Real Time PCR Kit EUL Number: EUL 0531-129-00 pdf
WHO EUL Public Report for SARS-CoV-2: LightPower iVA SARS-CoV-2 1stRT-rPCR Kit EUL Number: EUL 0524-210-00 pdf
WHO EUL Public Report for SARS-CoV-2: Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal gold) EUL Number: EUL 0540-216-00 pdf
WHO EUL Public Report for SARS-CoV-2: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test EUL Number: EUL 0553-219-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Multiple Real-Time PCR Kit for Detection of 2019-CoV EUL Number: EUL-0491-187-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: 2019 Novel Coronavirus (ORF1ab, E&N genes) Nucleic Acid Test Kit (Fluorescent Prob-based Real-time PCR Assay) EUL Number: EUL 0509-197-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: 3DMed 2019-nCoV RT-qPCR Detection Kit EUL Number: EUL-0488-184-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Abbott RealTime SARS-CoV-2 Assay EUL Number: EUL-0503-027-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: CareGENETM COVID-19 RT-PCR Kit EUL Number: EUL 0521-113-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: cobas SARS-CoV-2 Qualitative assay for use on the cobas 6800/8800 Systems EUL Number: EUL 0504-046-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: COVID-19 Coronavirus Real Time PCR Kit EUL Number: EUL-0515-202-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: COVID-19 Real-time PCR Kit EUL Number: EUL-0535-196-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: CoVTest-SR EUL Number: EUL 0506-194-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) EUL Number: EUL-0493-141-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Diagnostic Kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) EUL Number: EUL-0492-037-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: FTD SARS-CoV-2 EUL Number: EUL-0502-193-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Humasis COVID-19 Ag Test EUL Number: EUL 0613-247-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Ningbo Health Gene Technologies Co., Ltd (SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method)) EUL Number: EUL-0494-189-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR) EUL Number: EUL 0510-198-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit EUL Number: EUL-0486-139-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time PCR) EUL Number: EUL-0513-200-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay EUL Number: EUL-0501-192-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Primerdesign Ltd COVID-19 genesig Real-Time PCR Assay EUL Number: EUL-0489-185-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Real-time fluorescent RT-PCR kit for detecting 2019-nCoV EUL Number: EUL-0498-191-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: RT-PCR Kit for Detecting SARS-CoV-2 (Real-time Fluorescent PCR) EUL Number: EUL 0507-195-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: SARS-CoV-2 (2019-nCoV) qPCR Detection Kit EUL Number: EUL-0497-190-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent RT-RAA) EUL Number: EUL 0512-199-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) EUL Number: EUL 0490-186-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: SARS-CoV-2 Nucleic acid detection kit based on Real-Time PCR platform EUL number: EUL-0517-204-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Simplexa COVID-19 Direct and Simplexa COVID-19 Positive control Pack EUL Number: EUL-0526-212-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: STANDARD Q COVID-19 Ag Test EUL Number: EUL 0563-117-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Sure Status COVID-19 Antigen Card Test EUL Number: EUL-0590-010-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: TaqPath COVID‑19 CE‑IVD RT‑PCR Kit EUL Number: EUL-0525-156-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Veri-Q PCR 316 Coronovirus disease 2019 (COVID-19) EUL Number: EUL-0495-188-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Veri-Q PCR 316 Coronovirus Disease 2019 EUL Number: EUL-0495-188-00 pdf
Updated WHO EUL Public Report for SARS-CoV-2: Product: Wantai SARS-CoV-2 RT-PCR Kit EUL Number: EUL-0500-005-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product: Xpert Xpress SARS-CoV-2 EUL Number: EUL-0511-070-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product:Elecsys Anti-SARS-CoV-2 Qualitative assay for use on the cobas e 411/601/602/801 immuno analyzers EUL Number: EUL-0542-118-00 pdf
WHO EUL Public Report for SARS-CoV-2: Product:Novel Coronavirus (2019-nCoV) Antibody Rapid Test EUL Number: EUL 0552-219-00 pdf
WHO EUL Public Report for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) EUL Number: EUL 0593-004-00 pdf
WHO Guidelines for Malaria pdf
WHO Guidelines on submission of documentation for the pilot procedure for prequalification of biotherapeutic products for human insulin - full assessment pathway pdf
WHO Guidelines on submission of documentation for the pilot procedure for prequalification of human insulin approved by Stringent regualtory authorities - abridged assessment pathway pdf
WHO Guidelines on submission of documentation for the pilot procedure for prequalification of rituximab or trastuzumab approved by stringent regulatory authorities - Abridged Assessment pdf
WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products for rituximab and trastuzumab. Preparation of product dossiers in common technical document format - Full Assessment pdf
WHO Guidelines on submission of documentation for the procedure for prequalification of biotherapeutic products or their corresponding similar biotherapeutic products approved by stringent regulatory authorities pdf
WHO Guidelines on submission of documentation for the procedure for prequalification of similar biotherapeutic products pdf
WHO IFU for Bio-Speedy SARS-COV2 (2019-nCoV) qPCR Detection Kit - EUL number: 0497-190-00 pdf
WHO IFU for Elecsys® Anti-SARS-CoV-2 Qualitative assay for use on the cobas e 411/601/602/801 immunoanalyzers EUL number: 0542-118-00 pdf
WHO IFU for Panbio COVID-19 Ag Rapid Test Device (Nasal) - EUL number: 0587-032-00 pdf
WHO Immunization devices catalogue (all products and categories, June 2020) pdf
Updated WHO List of Prequalified Active Pharmaceutical Ingredients xlsx
WHO List of Prequalified Quality Control Laboratories pdf
WHO Operational Tool for efficient and effective lot release of SARS-CoV-2 (Covid-19) vaccines pdf
WHO Package Insert - Covid-19 Vaccine BIBP 9 June 21 pdf
Updated WHO Package Leaflet - BioNtech – COVID-19 mRNA vaccine (nucleoside modified) – COMIRNATY pdf
WHO Package Leaflet - COVID-19 Vaccine (ChAdOx1-S [recombinant]) pdf
WHO Package Leaflet - Janssen–Cilag International NV (Belgium) COVID-19 Vaccine (Ad26.COV2-S [recombinant]) pdf
WHO Package Leaflet - Moderna COVID-19 mRNA Vaccine (nucleoside modified) pdf
WHO Pilot Procedure for Prequalification of Biotherapeutic Products: Human Insulin pdf
WHO Pilot Procedure for Prequalification of Biotherapeutic Products: rituximab and trastuzumab pdf
WHO PQ Specific Addendum to the Risk Management Plan (RMP) pdf
WHO Prequalification of Vector Control Products - Dossier Table of Contents docx
WHO Prequalification of Vector Control Products - Post-PQ Change Application Form docx
WHO Prequalification of Vector Control Products - Pre-submission meeting request form docx
WHO Prequalification of Vector Control Products - Product Application Form docx
WHO Prequalification of Vector Control Products – Source Material Specification Application Form docx
WHO prequalified quality control laboratory (QCL) annual report on activities (1 October 2016) docx
WHO Procedure for Prequalification of Biotherapeutic Products or their corresponding Similar Biotherapeutic Products pdf
New WHO Product Information - BioNtech – COVID-19 mRNA vaccine (nucleoside modified) – COMIRNATY pdf
WHO Product Information - Moderna COVID-19 mRNA Vaccine (nucleoside modified) pdf
WHO Public Assessment Reports table (28 October 2016) pdf
