Addendum – Evaluation of Modified COVID-19 Vaccines pdf
Annex - WHO Model NRA/NCL Lot Release Certificate for SARS-CoV-2 (Covid-19) vaccines docx
Article 58 Scientific Opinion procedure pdf
Comirnaty Product Information pdf
Confidentiality Undertaking by National Regulatory Authorities pdf
Consent of applicants/manufacturers of a vaccine or a pharmaceutical product, diagnostics and vaccines for WHO to share information with the national regulatory authority(ies) confidentially in Emergency Situations docx
Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO pdf
Emergency Use Listing Procedure (EUL) (13 December 2020) pdf
Engagement de Confidentialité des Autorités Nationales de Réglementation pdf
First Invitation to manufacturers of vaccines against Covid-19 to submit an Expression of Interest (EOI) for evaluation by the WHO (Prequalification and/or EUL) pdf
Form for submission of variations docx
Guidance on variations to a prequalified vaccine pdf
Impact assessment of WHO prequalification and systems supporting activities (June 2019) pdf
Janssen EVD vaccine roadmap pdf
Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 18–21 September 2017: Agenda pdf
Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 2–5 December 2019: Agenda pdf
New List of WHO-contracted laboratories (March 2021) pdf
Model cover letter for the submission of a variation to a WHO-prequalified vaccine docx
MSD EVD vaccine roadmap pdf
nOPV2 Product Information pdf
Package Insert Tozinameran pdf
Product eligibility under the COVAX Facility pdf
Q&A for Guidelines on Emergency Use Listing Procedure pdf
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
New Recommendation for an Emergency Use Listing of COVID-19 Vaccine Janssen Submitted by Janssen – Cilag International N. V. (Belgium) 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
Updated Status of COVID-19 vaccines within WHO EUL/PQ evaluation process pdf
Terms of Reference for the Technical Advisory Group on Emergency Use Listing (EUL) pdf
Use of Emergency Use Listing procedure for vaccines against Covid-19 Q&A pdf
USPI Tozinameran pdf
Vaccines Under Assessment pdf
WHO Operational Tool for efficient and effective lot release of SARS-CoV-2 (Covid-19) vaccines pdf
WHO Package Leaflet - COVID-19 Vaccine (ChAdOx1-S [recombinant]) pdf
WHO recommendation COVID-19 mRNA vaccine (nucleoside modified) - COMIRNATY® pdf
WHO Recommendation for EUL of AZD1222 submitted by AstraZeneca AB and manufactured by SK Bioscience Co Ltd. (Published: 23 February 2021) pdf
WHO Recommendation for EUL of COVISHIELD™ submitted by Serum Institute of India Pvt Ltd pdf
WHO Summary of Product Characteristics - COVID-19 Vaccine (ChAdOx1-S [recombinant]) pdf
WHO TRS 978 - Annex 6 - Prequalification Vaccine Procedure pdf
WHO workshop on implementation of good manufacturing practices for biological products, Seoul, September 2018 pdf
СОГЛАШЕНИЕ О СОБЛЮДЕНИИ КОНФИДЕНЦИАЛЬНОСТИ ИНФОРМАЦИИ НАЦИОНАЛЬНЫМ ОРГАНОМ РЕГУЛИРОВАНИЯ pdf
تعهد بالتزام السرية من قِبل السلطات التنظيمية الوطنية pdf
