Annex - WHO Model NRA/NCL Lot Release Certificate for SARS-CoV-2 (Covid-19) vaccines docx
Annotated labelling template (25 October 2016) docx
Annotated patient information leaflet (PIL) (24 October 2016) docx
Annotated summary of product characteristics (SmPC) template (24 October 2016) docx
Clinical trial protocol: zinc sulphate acceptability study in children with acute diarrhoea: a prospective, open-label (multicentre) interventional study docx
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
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
Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the procedure, Appendix 2 pdf
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
Generic Risk Assessment Model for Indoor Residual Spraying of Insecticides - Example Worksheet xlsx
Generic Risk Assessment Model for Insecticide-Treated Nets - Empty Worksheet xlsx
Generic Risk Assessment Model for Insecticide-Treated Nets - Example Worksheet xlsx
IVD principles checklist docx
Labelling template (25 October 2016) docx
Model cover letter for the submission of a variation to a WHO-prequalified vaccine docx
Model letter of access: active pharmaceutical ingredient master file (APIMF) (14 February 2016) docx
National regulatory authority participation agreement and undertaking for national regulatory focal point(s), Appendix 1, Part A pdf
Notification of an outcome of the national registration provided by the participating company to WHO-PQT, Annex 7 docx
Notification of outcomes of national registration procedure by the NRA, Appendix 3, Part C pdf
Patient information leaflet (PIL) template (24 October 2016) docx
PQS laboratory report template docx
Quality information summary (QIS) (01 June 2020) docx
Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA) (QIS-BTP-SRA) docx
Quality information summary (QIS) of the finished pharmaceutical product (FPP) approved by the reference stringent regulatory authority (SRA) (QIS-SRA) (28 October 2013) docx
Quality overall summary: product dossier (QOS-PD) docx
Report on post-registration actions in respect of a product registered under the procedure, Appendix 4 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
Stringent regulatory authority sharing of non-public information concerning product with the national regulatory authority and the World Health Organization (WHO), Annex 3A docx
Summary of product characteristics (SmPC) template (24 October 2016) docx
User feedback form docx
WHO Declaration of Manufacturing Sites docx
WHO Declaration of Product Formulation docx
WHO Prequalification of Vector Control Products - Dossier Table of Contents docx
WHO prequalified quality control laboratory (QCL) annual report on activities (1 October 2016) docx
تعهد بالتزام السرية من قِبل السلطات التنظيمية الوطنية pdf
