WHO EUL Public Report for SARS-CoV-2: COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit - EUL Number: EUL 0523-209-00 pdf
WHO EUL Public Report for SARS-CoV-2: FORA/VTRUST COVID-19 Antigen Rapid Test, TD-4531B - EUL Number: EUL 0718-272-00 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 IVDs medical devices used for the qualitative detection of Mycobacterium tuberculosis complex DNA and mutations associated with drug-resistant tuberculosis to apply for WHO prequalification assessment as of 22 September pdf
1st Invitation to manufacturers of medicinal products for treatment of disorders caused by use of tobacco, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit 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 medicinal products for treatment of multi-drug resistant bacterial infections, 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
2021 WHO PQT Medicines BTP/SBP Workshop for Manufacturers - Agenda pdf
20th Invitation for Expression of Interest (EOI) for medicines against HIV infection and related diseases to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
21st Invitation to manufacturers of antimalarial medicines to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
21st Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
2nd 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
2nd Invitation to Manufacturers of therapeutics against Ebola Virus Disease to submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit pdf
32nd Invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API 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
5th 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 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
8th Invitation to manufacturers of therapeutics against COVID-19 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: prequalification of in vitro diagnostics (PQDx_173 v4, 04 January 2021)
Acceptance of non-plant-derived-artemisinin offers potential to increase access to malaria treatment (issued 8 May 2013) pdf
Additional guidance on submission requirements for medroxyprogesterone acetate depot injection products using the Common Technical Document (CTD) format (1 August 2015) pdf
Advice to manufacturers (10 October 2016) pdf
Agenda - PQT Medicines 2nd Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) Workshop for Manufacturers – 30 September 2022 pdf
Agenda - PQT Medicines 5th Annual Medicines Quality Workshop for Manufacturers - 26-29 September 2022 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
Antivipmyn Africa - Snake Antivenom for Sub-Saharan Africa pdf
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 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 docx
Application for biowaiver for zinc product (10 November 2016) docx
Application for biowaiver: Biopharmaceutics Classification System (BCS) docx
Application for new version of an active pharmaceutical ingredient master file (APIMF) 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 2nd Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) Workshop for Manufacturers – 30 September 2022 docx
Application Form - PQT Medicines 5th Annual Medicines Quality Workshop for Manufacturers - 26-29 September 2022 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) doc
