19th Invitation to manufacturers of antimalarial medicines to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
19th Invitation to manufacturers of medicinal products for HIV infection and related diseases to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
1st Invitation to laboratories to submit an expression of interest (23 May 2016) pdf
1st Invitation to Manufacturers of Biotherapeutic Products (BTPs) and Similar Biotherapeutic Products (SBPs)to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Team - Biotherapeutic Products (BTPs) pdf
1st Invitation to Manufacturers of Human Insulin to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Team - Biotherapeutic Products (BTPs) pdf
1st Invitation to manufacturers of medicinal products for treatment of infections in newborn and young infants and childhood pneumonia, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
1st Invitation to manufacturers of zinc products to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines (10 November 2016) pdf
20th Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
24th Invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API evaluation to the WHO Prequalification Unit pdf
2nd Invitation to manufacturers of therapeutics against COVID-19 to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
3rd Invitation to manufacturers of influenza-specific antiviral medicines to submit an expression of interest for product evaluation to the WHO Prequalification Team: medicines (3 July 2015) pdf
3rd Invitation to quality control laboratories (QCLs) to submit an expression of interest for prequalification to the WHO Prequalification Team: medicines (1 June 2011) pdf
4th Invitation to manufacturers of medicinal products for treatment of hepatitis B and C to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines (4 April 2017) pdf
7th Invitation to manufacturers of medicinal products for the treatment of neglected tropical diseases to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
9th Invitation to manufacturers of reproductive health products to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines pdf
A quiet revolution in global public health: the World Health Organization's Prequalification of Medicines Programme pdf
A risk-based approach for the assessment of in vitro diagnostics (IVDs) (PQDx_152 v1, 13 May 2014) pdf
Abridged Prequalification Assessment (PQDx 173 - 04 January 2021) pdf
Acceptance of non-plant-derived-artemisinin offers potential to increase access to malaria treatment (issued 8 May 2013) pdf
Addendum – Evaluation of Modified COVID-19 Vaccines pdf
Additional guidance for submission of the acceptability study for prequalification of zinc tablets and oral liquid (solution) (25 September 2018) pdf
Additional guidance on submission requirements for medroxyprogesterone acetate depot injection products using the Common Technical Document (CTD) format (1 August 2015) pdf
Advice on the selection of excipients for zinc tablets and solutions (10 November 2016) pdf
Advice to manufacturers (10 October 2016) pdf
Annex - WHO Model NRA/NCL Lot Release Certificate for SARS-CoV-2 (Covid-19) vaccines docx
Annotated labelling template (25 October 2016) docx
Annotated patient information leaflet (PIL) (24 October 2016) docx
Annotated summary of product characteristics (SmPC) template (24 October 2016) docx
Appendix 1B: NMRA focal point(s)' confidentiality undertaking pdf
Appendix 3: Part B Acceptance by the NMRA to apply the procedure pdf
Application for a biowaiver: additional strength (22 November 2018) docx
Application for active pharmaceutical ingredient (API) prequalification based upon previous stringent regulatory authority (SRA) assessment ‒ history of changes (1 May 2013) docx
Application for active pharmaceutical ingredient master file (APIMF) procedure docx
Application for an active pharmaceutical ingredient master file (APIMF) amendment (25 January 2019) docx
Application for biowaiver for zinc product (10 November 2016) docx
Application for biowaiver: Biopharmaceutics Classification System (BCS) (22 November 2018) docx
Application for new version of an active pharmaceutical ingredient master file (APIMF) (23 May 2017) docx
Application for prequalification of an active pharmaceutical ingredient (API-abridged) docx
Application for prequalification of an active pharmaceutical ingredient (API-standard) docx
Application Form - PQT Medicines Virtual Assessment Training 2020 docx
Application form for prequalification of a male circumcision device (PQMC_015 v1, 13 September 2011) pdf
Application of reference-scaled criteria for AUC in bioequivalence studies conducted for submission to PQTm pdf
Applications for Finished Pharmaceutical Product (FPP) Prequalification based on Technology Transfer (TT) pdf
Artemisinin derivatives: summary of nonclinical safety data (24 January 2016) pdf
Article 58 Scientific Opinion procedure pdf
Assessment of response to position paper "WHO response to the USFDA warning letter issued to Mylan Laboratories Ltd, Nashik" pdf
Boas práticas da OMS para laboratórios de controle de qualidade de produtos farmacêuticos pdf
BTIF - Appendix 1 - Template for Study Individual Concentration and PK Data xlsx
Buenas prácticas de la OMS para laboratorios de control de calidad de productos farmacéuticos (2010) pdf
CD4 technologies under assessment pdf
Change report form for a WHO-prequalified in vitro diagnostic (PQDx_119 v2, 2 December 2016) docx
Change reporting form for a WHO-prequalified male circumcision device (PQMC_119 v1, April 2019) docx
Cholera rapid diagnostic tests under assessment pdf
Clarification on the process for introducing a supplier of non-plant-derived artemisinin (1 November 2016) pdf
Clarification with respect to a stringent regulatory organization as applicable to the stringent regulatory authority (SRA) guideline (15 February 2017) pdf
Clinical trial protocol: zinc sulphate acceptability study in children with acute diarrhoea: a prospective, open-label (multicentre) interventional study docx
Coartem Basic Patient Leaflet pdf
Collaboration in verification of GMP compliance between WHO-PQT and medicines manufacturers interested in submitting for WHO prequalification (16 June 2016) pdf
Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (16 January 2010) pdf
Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex B): Expression of interest (18 January 2010) docx
Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex C): Shared inspection schedule (18 January 2010) xlsx
Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex D): Form for nomination of an observer or co-inspector (18 January 2010) docx
Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex E): Details of external expert (18 January 2010) docx
Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex F): Provisions for evaluators of product dossiers and for inspectors (18 January 2010) docx
Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex G): Appointment as an observer or co-inspector in a WHO inspection team (18 January 2010) pdf
Collaborative procedure between World Health Organization and selected national medicines regulatory authorities in inspection activities (Annex A): Invitation to participate (January 2010) docx
Collaborative procedure between World Health Organization and selected national medicines regulatory authorities in inspection activities (Annex H): Appointment of observer or co-inspector: template letter to supervisor (18 January 2010) pdf
Collaborative Procedure Registered List - Registered Products xlsx
Comirnaty Product Information pdf
Common Deficiencies in Finished Pharmaceutical Product (FPP) Dossiers - Additional Guidance to Manufacturers pdf
Concept note: Requirements for provision of a ‘bridging’ report for SRA-approved medicines for consideration of registration in non-SRA settings docx
Confidentiality Undertaking by National Regulatory Authorities pdf
Consent of applicants/manufacturers of a vaccine or a pharmaceutical product, diagnostics and vaccines for WHO to share information with the national regulatory authority(ies) confidentially in Emergency Situations docx
Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the procedure, Appendix 2 pdf
Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO pdf
Consultation on the documentary evidence and independent performance evaluation requirements for the Emergency Use Assessment and Listing procedure for Zika virus in vitro diagnostics, March 2016 pdf
Coordination between WHO Living Guidelines and WHO EUL and PQ processes for Therapeutics in the context of COVID-19 pdf
Copenhagen hotels offering preferred rates 2017 pdf
Descripción general de la Precalificación de Diagnósticos in vitro de la OMS pdf
Directives pour la préparation d'un dossier d'information par le laboratoire (2011) pdf
Disclaimer for WHO list of prequalified diagnostic products pdf
DRAFT TSS 10 In vitro diagnostic (IVD) medical devices used for the qualitative and quantitative detection of hepatitis C RNA — to be published shortly — draft document pdf
DRAFT TSS 11 In vitro diagnostic (IVD) medical devices used for the quantitative detection of HIV-1 nucleic acid — to be published shortly — draft document pdf
DRAFT TSS 12 In vitro diagnostic (IVD) medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid — to be published shortly — draft document pdf
DRAFT TSS 13 Rapid diagnostic tests to detect hepatitis B surface antigen — to be published shortly pdf
DRAFT TSS 14 Immunoassays to detect hepatitis B virus surface antigen — to be published shortly pdf
DRAFT TSS 15 In vitro diagnostic (IVD) medical devices used for the quantitative detection of hepatitis B nucleic acid — to be published pdf
DRAFT TSS 9 Immunoassays to detect HIV antibody and/or antigen — to be published shortly pdf
Draft: Instructions for compilation of a product dossier ‒ IMDRF ToC (PQDx_018, 21 March 2020) pdf
E001 product dossier checklist xlsx
E003 product dossier checklist xlsx
E004 product dossier checklist xlsx
E006 product dossier checklist xlsx
E007 product dossier checklist xlsx
Emergency Use Assessment and Listing Procedure (EUAL) for candidate in vitro diagnostics (IVDs) for use in the context of a public health emergency (7 July 2015) pdf
Emergency Use Listing Procedure (EUL) (13 December 2020) pdf
Engagement de Confidentialité des Autorités Nationales de Réglementation pdf
EUL 0495-188-00 Veri-Q PCR 316 Coronavirus disease 2019 (COVID19) Detection System IFU pdf
Example of a completed application for a new version of an active pharmaceutical ingredient master file (APIMF) (23 May 2017) pdf
Example of a completed application for an amendment to an active pharmaceutical ingredient master file (APIMF) (3 March 2016) pdf
