V Recommandation pour l'utilisation d'urgence (Procédure EUL) du nouveau Vaccin Antipoliomyélitique Oral de Type 2 (nVPO2) de PT Biofarma (Persero) (Traduction de la version anglaise publiée le 01 Décembre 2020) PDF
V Recommendation for an Emergency Use Listing (EUL) of Novel Oral Polio Vaccine Type 2 (nOPV2) submitted by PT BioFarma (Persero) - (Published 01 December 2020) PDF
V Recommendation for an Emergency Use Listing (EUL) of Tozinameran (COVID-19mRNA Vaccine (Nucleoside Modified)) submitted by BioNTech Manufacturing GmbH PDF
V Recommendation for an Emergency Use Listing of COVID-19 mRNA Vaccine (nucleoside modified) submitted by Moderna Biotech (Spain) PDF
V Recommendation for an Emergency Use Listing of COVID-19 Vaccine Janssen Submitted by Janssen – Cilag International N. V. (Belgium) PDF
M Recommendations on the content of a survey protocol: Survey of the quality of antimalarial medicines PDF
M Recommended comparator products: medicines for infections in newborns and young infants and childhood pneumonia PDF
M Recommended comparator products: Treatment of multi-drug resistant bacterial infections (9 January 2024) PDF
M Règles OMS de bonnes pratiques applicables par les laboratoires de contrôle qualité pharmaceutique - TRS 957 - Annex 1 PDF
M Report on post-registration actions in respect of a product registered under the procedure, Appendix 4 PDF
M Request for Proposals (RFP): IT support, application and data management activities to the WHO Prequalification Unit – Medicines Assessment Team PQT/MED PDF
M Request to stringent regulatory authority for permission to share stringent regulatory authority’s non-public information concerning product with the national regulatory authority/ies and the World Health Organization, Annex 3B DOCX
M Request to submit stability data with the submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities (1 March 2016) PDF
M Requirements for provision of a ‘bridging’ report for SRA-approved medicines for consideration of registration in non-SRA settings, Annex 8 DOCX
IVD Risk-based classification of diagnostics for WHO prequalification) (PQDx_172 v1, 13 May 2014) PDF
V Roadmap for introduction and roll-out of Janssen VAC52150 (Ad26.ZEBOV, MVA-BN®-Filo) Ebola Virus Disease vaccine in African countries PDF
V Roadmap for introduction and roll‐out of Merck rVSV‐ZEBOV Ebola Virus Disease vaccine in African countries PDF