Appendix 3: Part B Acceptance by the NMRA to apply the procedure pdf
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Application for active pharmaceutical ingredient (API) prequalification based upon previous stringent regulatory authority (SRA) assessment ‒ history of changes (1 May 2013) docx
Application for active pharmaceutical ingredient master file (APIMF) procedure docx
Application for an active pharmaceutical ingredient master file (APIMF) amendment (25 January 2019) docx
Application for biowaiver for zinc product (10 November 2016) docx
Application for biowaiver: Biopharmaceutics Classification System (BCS) docx
Application for new version of an active pharmaceutical ingredient master file (APIMF) (23 May 2017) docx
Application for prequalification of an active pharmaceutical ingredient (API-abridged) docx
Application for prequalification of an active pharmaceutical ingredient (API-standard) docx
Application Form - PQT Medicines Virtual Assessment Training 2020 docx
Application form for prequalification of a male circumcision device (PQMC_015 v1, 13 September 2011) doc
Change report form for a WHO-prequalified in vitro diagnostic (PQDx_119 v2, 2 December 2016) docx
Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex B): Expression of interest (18 January 2010) docx
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
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
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
Expression of interest submission form for prequalification evaluating laboratories (PQDx_250 v1.0, 23 May 2016) docx
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
Form for submission of variations docx
Meeting request: assessment (7 February 2016) docx
National regulatory authority participation agreement and undertaking pdf
Notification of a change(s) to the key information of a product approved by a stringent regulatory authority (SRA) (4 December 2015) docx
Prequalification of immunization equipment and devices pre-submission form pdf
Presentation of bioequivalence trial information - BTIF docx
Screening checklist for generic products doc
Variation to a prequalified finished pharmaceutical product (FPP) docx
Variation to a prequalified finished pharmaceutical product (FPP): major, minor or immediate notification (5 December 2015) docx
WHO Prequalification of Vector Control Products - Post-PQ Change Application Form docx
WHO Prequalification of Vector Control Products - Pre-submission meeting request form docx
WHO Prequalification of Vector Control Products - Product Application Form docx
WHO Prequalification of Vector Control Products – Source Material Specification Application Form docx
WHO Request for Determination of Pathway - Vector Control docx
Zinc product: acceptability study summary (11 November 2016) docx
