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
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
Recommendation for an Emergency Use Listing (EUL) of Tozinameran (COVID-19mRNA Vaccine (Nucleoside Modified)) submitted by BioNTech Manufacturing GmbH pdf
Recommendation for an Emergency Use Listing of COVID-19 mRNA Vaccine (nucleoside modified) submitted by Moderna Biotech (Spain) pdf
Recommendation for an Emergency Use Listing of COVID-19 Vaccine Janssen Submitted by Janssen – Cilag International N. V. (Belgium) pdf
Recommendations on the content of a survey protocol: Survey of the quality of antimalarial medicines pdf
Recommended comparator products: anti-tuberculosis medicines pdf
Recommended comparator products: antimalarial medicines pdf
Recommended comparator products: influenza-specific antiviral medicines pdf
Recommended comparator products: medicines for hepatitis B and C pdf
Updated Recommended comparator products: medicines for HIV/AIDS and related diseases pdf
Recommended comparator products: medicines for infections in newborns and young infants and childhood pneumonia pdf
Recommended comparator products: neglected tropical disease medicines pdf
Recommended comparator products: reproductive health medicines pdf
Recommended comparator products: therapeutics against COVID-19 pdf
Report on post-registration actions in respect of a product registered under the procedure, Appendix 4 pdf
Report on the international API inspection programme 2011 - 2016 pdf
Report on the meeting on the survey of the quality of antimalarials in sub-Saharan Africa pdf
Reportable changes to a prequalified male circumcision device (PQMC_121 v1, April 2019) pdf
Request for Proposals (RFP): IT support, application and data management activities to the WHO Prequalification Unit – Medicines Assessment Team PQT/MED pdf
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
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
Requirements for provision of a ‘bridging’ report for SRA-approved medicines for consideration of registration in non-SRA settings, Annex 8 docx
Requirements for stability studies of finished pharmaceutical products (29 March 2010) pdf
Risk-based classification of diagnostics for WHO prequalification) (PQDx_172 v1, 13 May 2014) pdf
Roadmap for assessment of nOPV2 pdf
Roadmap for assessment of nOPV2 manufactured by PT Biofarma under the EUL procedure pdf
Roadmap for evaluation of AstraZeneca ADZ122 Vaccine against Covid-19 pdf
Roadmap for evaluation of Jansen Ad26.COV2-S (recombinant) vaccine against Covid-19 pdf
Roadmap for introduction and roll-out of Janssen VAC52150 (Ad26.ZEBOV, MVA-BN®-Filo) Ebola Virus Disease vaccine in African countries pdf
Roadmap for introduction and roll‐out of Merck rVSV‐ZEBOV Ebola Virus Disease vaccine in African countries pdf
Rolling review of COVID-19 vaccines pdf
Règles de bonnes pratiques applicables par les laboratoires (2010) pdf
