M PQT/MED-specific Annotations for the WHO guideline on Biopharmaceutics Classification System-based biowaivers PDF Guideline/guidance
IVD Pre-submission form for application for prequalification of an in vitro diagnostic (PQDx_015) DOCX Application form
VCP Preparation of a Site Master File for manufacturers of Vector Control Products. PDF Guideline/guidance
VCP Preparation of entomology study reports - Annex I. ITN studies (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Preparation of entomology study reports - Annex II. IRS studies (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Preparation of entomology study reports - Annex III. Larvicide studies (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Preparation of entomology study reports - Annex IV. Space spray studies (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Preparation of entomology study reports (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Preparing an application for electronic submission (VCP Advice to manufacturers series) PDF Guideline/guidance
M Préqualification des laboratories de contrôle de qualité. Procédure d'evaluation de l'acceptabilité, de principe, des laboratoires de contrôle qualité à l'usage des institutions des Nations Unies PDF Guideline/guidance
IVD Prequalification fees for male circumcision devices (PQMC v1, 15 April 2019) PDF Guideline/guidance
M Principles for prioritizing dossiers within the WHO Prequalification Team: medicines (27 October 2011) PDF Information note
IVD Priority Categorization of Applications for Prequalification (PQ) and Emergency Use Listing (EUL) Assessments of in vitro diagnostics PDF Guideline/guidance
M Procedure to enable national registration of products prequalified based on SRA approval through CRP-18-March-2025 PDF Guideline/guidance
M Procedure to enable prequalification products approved by SRAs for use outside the SRA region-18 March 2025 PDF Guideline/guidance
M Product Recall - Moxifloxacin 100mg Dispersible Tablets (TB342): Batch BMC5801A PDF Information note
VCP Product Review Report - Insecticide Treated Nets Formulated with Pyrethroid+PBO and Pyrethroid+2ndActive PDF Report
IVD Protocol for the evaluation of nucleic acid tests for the diagnosis of tuberculosis (TB NAT) Guideline/guidance
IVD Protocol for the performance evaluation of nucleic acid tests for the quantitative detection of hepatitis B virus DNA for WHO prequalification assessment V 1.1 Nov 2023 Guideline/guidance
IVD Protocol for the performance evaluation of rapid diagnostic tests for the detection of Vibrio cholerae O1 or O1/O139 for WHO prequalification assessment V 2.2 Nov 2023 Guideline/guidance
IVD Public announcement to TB in vitro diagnostics manufacturers, procurement agencies and national TB programmes on inclusion of WHO Prequalification for TB in vitro diagnostics PDF Advocacy material
IVD Public announcement to TB IVDs manufacturers, procurement agencies and national TB programmes: Extension of WHO GTB recommendation PDF Information note
M Public consultation on proposed financing model for WHO prequalification: summary of responses received Application form
M Public consultation on proposed financing model for WHO prequalification: summary of responses received (issued 2 June 2015) PDF Report
IVD Public Report for Alinity m MPXV AMP Kit and Alinity m MPXV CTRL Kit, (MPXV 12644-027-00) PDF Report