M WHO guideline on Biopharmaceutics Classification System-based biowaiver (2024) - TRS1052, Annex 7 PDF Guideline/guidance
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of biotherapeutic products for human insulin - full assessment pathway PDF Guideline/guidance
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of human insulin approved by Stringent regualtory authorities - abridged assessment pathway PDF Guideline/guidance
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of rituximab or trastuzumab approved by stringent regulatory authorities - Abridged Assessment PDF Guideline/guidance
M 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 Guideline/guidance
M 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 Guideline/guidance
M WHO Guidelines on submission of documentation for the procedure for prequalification of similar biotherapeutic products PDF Guideline/guidance
ID WHO Immunization Devices Guidelines for applicants & prequalification holders PDF Guideline/guidance
ID WHO Immunization Devices Pocket Guide for applicants & prequalification holders PDF Guideline/guidance
V WHO Operational Tool for efficient and effective lot release of SARS-CoV-2 (Covid-19) vaccines PDF Guideline/guidance
V WHO Package Leaflet - BioNtech Tozinameran – COVID-19 mRNA vaccine (nucleoside modified) - Grey Cap PDF Guideline/guidance
V WHO Package Leaflet - BioNtech Tozinameran – COVID-19 mRNA vaccine (nucleoside modified) - Orange Cap PDF Guideline/guidance
V WHO Package Leaflet - BioNtech Tozinameran – COVID-19 mRNA vaccine (nucleoside modified) - Purple Cap PDF Guideline/guidance
M WHO Pilot Procedure for Prequalification of Biotherapeutic Products: Human Insulin PDF Guideline/guidance
M WHO Pilot Procedure for Prequalification of Biotherapeutic Products: rituximab and trastuzumab PDF Guideline/guidance
VCP WHO Prequalification of Vector Control Products - Post-PQ Change Application Form DOCX Application form
VCP WHO Prequalification of Vector Control Products - Pre-submission meeting request form DOCX Application form
VCP WHO Prequalification of Vector Control Products – Source Material Specification Application Form DOCX Application form
M WHO prequalified quality control laboratory (QCL) annual report on activities (1 October 2016) DOCX Template