M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex D): Form for nomination of an observer or co-inspector (18 January 2010) DOCX
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex E): Details of external expert (18 January 2010) DOCX
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex F): Provisions for evaluators of product dossiers and for inspectors (18 January 2010) DOCX
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex G): Appointment as an observer or co-inspector in a WHO inspection team (18 January 2010) PDF
M Collaborative procedure between World Health Organization and selected national medicines regulatory authorities in inspection activities (Annex A): Invitation to participate (January 2010) DOCX
M Collaborative procedure between World Health Organization and selected national medicines regulatory authorities in inspection activities (Annex H): Appointment of observer or co-inspector: template letter to supervisor (18 January 2010) PDF
M Common Deficiencies in Finished Pharmaceutical Product (FPP) Dossiers - Additional Guidance to Manufacturers PDF
M Concept note: Requirements for provision of a ‘bridging’ report for SRA-approved medicines for consideration of registration in non-SRA settings DOCX
M Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the procedure, Appendix 2 PDF
M Coordination between WHO Living Guidelines and WHO EUL and PQ processes for Therapeutics in the context of COVID-19 PDF
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