IVD Expression of interest submission form for prequalification evaluating laboratories (IVD/TP/12a v3.1) DOCX Application form
M Expression of interest to national regulatory authority (NRA) in the assessment and accelerated national registration, acceptance by NRA and notification of procedure outcomes, Appendix 3, Part A PDF Template
M Expression of interest to participate in the system of peer audits within the network of quality control laboratories involved in WHO prequalification (1 October 2016) DOCX Application form
M Famy Care's ethinylestradiol/levonorgestrel with ferrous fumarate placebo tablets prequalified PDF Guideline/guidance
M FAQ: Active pharmaceutical ingredient (API) micronization (13 September 2019) PDF Guideline/guidance
IVD FAQ: EUL assessment of IVD to detect SARS-CoV-2 or anti-SARS-CoV-2 antibodies PDF Guideline/guidance
M FAQ: WHO Collaborative Procedure between WHO and National Medicines Regulatory Authorities in Assessment and Accelerated National Registration PDF Guideline/guidance
IVD FAQ: WHO Global TB programme class recommendations and WHO Prequalification (PQ) product assessments PDF Advocacy material
ID Follow-up on the suspension of eight (8) models of vaccine refrigerators, from Vestfrost A/S, Esberg, Denmark PDF Information note
M Frequently Asked Questions (FAQ) - WHO Pilot Procedure for Prequalification of Biotherapeutic Products: rituximab and trastuzumab PDF Guideline/guidance
IS Frequently asked questions by the manufacturing, trial and testing organizations in connection with some of their constraints faced during the COVID-19 outbreak PDF Information note
M Frequently asked questions by the manufacturing, trial and testing organizations in connection with some of their constraints faced during the COVID-19 outbreak PDF Information note
VCP Fulfilling dossier and data requirements (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Generic Risk Assessment Model for Indoor Residual Spraying of Insecticides - Empty Worksheet XLSX
VCP Generic Risk Assessment Model for Indoor Residual Spraying of Insecticides - Example Worksheet XLSX Template
VCP Generic Risk Assessment-Human Health: ITNs formulated with Alpha-cypermethrin PDF Guideline/guidance
VCP Generic Risk Assessment-Human Health: ITNs formulated with Piperonyl-Butoxide PDF Guideline/guidance
M Guidance - Nitrosamine contamination policy for Active Pharmaceutical Ingredients PDF Guideline/guidance
IVD Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (2020) Guideline/guidance
ID Guidance for the prequalification of single-phase voltage stabilizers: E007/VS PDF Guideline/guidance
M Guidance on amendments to an active pharmaceutical ingredient master file (APIMF) submitted in support of a prequalified finished pharmaceutical product (FPP) or prequalified API PDF Guideline/guidance
M Guidance on plain language descriptions of visual appearance for oral dosage forms in WHOPARs PDF Guideline/guidance
M Guidance on the Submission of Applications for Prequalification of Zinc Tablets and Zinc Oral Liquid (Solution) PDF Guideline/guidance
M V Guidelines for good clinical practice (GCP) for trials on pharmaceutical products - TRS 850 PDF Guideline/guidance
M V Guidelines for good clinical practice (GCP) for trials on pharmaceutical products - TRS 850 PDF Guideline/guidance