M Coronavirus disease (COVID-19) pandemic Product specific requirements for currently invited combination of casirivimab and imdevimab PDF
M Coronavirus disease (COVID-19) pandemic Product specific requirements for currently invited IL-6 inhibitors (tocilizumab and sarilumab) PDF
M Directives de l’OMS pour la préparation d’un dossier d’information par le laboratoire - TRS 961 - Annex 13 PDF
M Example of a Completed Application for a New Version of an Active Pharmaceutical Ingredient Master File (APIMF) PDF
M Example of a Completed Application for an Amendment to an Active Pharmaceutical Ingredient Master File (APIMF) PDF
M Expression of interest to national regulatory authority (NRA) in the assessment and accelerated national registration, acceptance by NRA and notification of procedure outcomes, Appendix 3, Part A PDF
M Expression of interest to participate in the system of peer audits within the network of quality control laboratories involved in WHO prequalification (1 October 2016) DOCX
M FAQ: WHO Collaborative Procedure between WHO and National Medicines Regulatory Authorities in Assessment and Accelerated National Registration PDF
M Frequently Asked Questions (FAQ) - WHO Pilot Procedure for Prequalification of Biotherapeutic Products: rituximab and trastuzumab PDF
M Frequently asked questions by the manufacturing, trial and testing organizations in connection with some of their constraints faced during the COVID-19 outbreak PDF
M Guidance on amendments to an active pharmaceutical ingredient master file (APIMF) submitted in support of a prequalified finished pharmaceutical product (FPP) or prequalified API PDF
M Guidance on the Submission of Applications for Prequalification of Zinc Tablets and Zinc Oral Liquid (Solution) PDF
IVD M HIV market report: the state of HIV treatment, testing and preventing in low- and middle-income countries (CHAI, September 2020) PDF
ID IVD M V VCP Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF
M Joint UNICEF & WHO meeting with manufacturers and suppliers, Denmark, 24‒26 September 2012: Programme description
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 14–27 September 2018: Agenda PDF
ID IVD IS M V VCP Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 18–21 September 2017: Agenda PDF
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 18–21 September 2017: Programme description PDF
ID IVD M V VCP Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 2–5 December 2019: Agenda PDF
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 24–27 September 2018: Programme description PDF
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers, Denmark, 18‒21 September 2017: Background for WHO vector control prequalification PDF