M Règles OMS de bonnes pratiques applicables par les laboratoires de contrôle qualité pharmaceutique - TRS 957 - Annex 1 PDF Guideline/guidance
M Report on post-registration actions in respect of a product registered under the procedure, Appendix 4 PDF Template
M Report on the meeting on the survey of the quality of antimalarials in sub-Saharan Africa PDF Report
M Request for Proposals (RFP): IT support, application and data management activities to the WHO Prequalification Unit – Medicines Assessment Team PQT/MED PDF
M 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 Template
M Request to submit stability data with the submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities (1 March 2016) PDF Guideline/guidance
M Requirements for provision of a ‘bridging’ report for SRA-approved medicines for consideration of registration in non-SRA settings, Annex 8 DOCX Information note
M Requirements for stability studies of finished pharmaceutical products (29 March 2010) PDF Guideline/guidance
M Revised active pharmaceutical ingredient master file (APIMF) amendment guidance PDF Guideline/guidance
M Screening checklist for biotherapeutic products and their corresponding SBPs - Abridged Pathway DOCX Guideline/guidance
M Screening checklist for biotherapeutic products and their corresponding SBPs - Full Pathway DOCX Guideline/guidance
M Section guidance for part 3 — patient information leaflet (PIL) — of a WHO Public Assessment Report (WHOPAR) (24 October 2016) PDF Guideline/guidance
M Section guidance for part 4 — summary of product characteristics (SmPC) — of a WHO Public Assessment Report (WHOPAR) (25 October 2016) PDF Guideline/guidance
M Section guidance for part 5 — labelling — of a WHO Public Assessment Report (WHOPAR) (24 October 2016) PDF
M Section guidance for part 6 of — scientific discussion — of a WHO Public Assessment Report (WHOPAR) (25 October 2016) PDF Guideline/guidance
M Stability data for finished pharmaceutical products (FPPs) approved by stringent regulatory authorities (SRAs) PDF Template
M Stability testing of active pharmaceutical ingredients and finished pharmaceutical products - TRS 1010 - Annex 10 PDF Report
M Stability testing of active pharmaceutical ingredients and finished pharmaceutical products - WHO Technical Report Series, No.1010, Annex 10, 2018 PDF Guideline/guidance
M Stringent regulatory authority sharing of non-public information concerning product with the national regulatory authority and the World Health Organization (WHO), Annex 3A DOCX Template
M Survey of the quality of anti-tuberculosis medicines circulating in selected newly independent states of the former Soviet Union (issued November 2011) PDF Report
M Survey of the quality of antiretroviral medicines circulating in selected African countries (issued September 2007) PDF Report
M Survey of the quality of medicines identified by the United Nations Commission on Life Saving Commodities for women and children PDF Report
M Survey of the quality of selected antimalarial medicines circulating in six countries of sub-Saharan Africa (issued January 2011) PDF Report
M Survey of the quality of selected antiretroviral medicines circulating in five African countries (2019) PDF Report
M Three more Nigerian companies meet international pharmaceutical manufacturing standards PDF Guideline/guidance
M Use of ICHQ3D guideline in the assessment of APIMFs submitted in support of an FPP or prequalified API (18 October 2019) PDF Guideline/guidance
M Variation to a prequalified finished pharmaceutical product (FPP): major, minor or immediate notification (5 December 2015) DOCX Application form
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of biotherapeutic products for human insulin - full assessment pathway PDF Guideline/guidance
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of human insulin approved by Stringent regualtory authorities - abridged assessment pathway PDF Guideline/guidance
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of rituximab or trastuzumab approved by stringent regulatory authorities - Abridged Assessment PDF Guideline/guidance
M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products for rituximab and trastuzumab. Preparation of product dossiers in common technical document format - Full Assessment PDF Guideline/guidance
M WHO Guidelines on submission of documentation for the procedure for prequalification of biotherapeutic products or their corresponding similar biotherapeutic products approved by stringent regulatory authorities PDF Guideline/guidance
M WHO Guidelines on submission of documentation for the procedure for prequalification of similar biotherapeutic products PDF Guideline/guidance
M WHO Pilot Procedure for Prequalification of Biotherapeutic Products: Human Insulin PDF Guideline/guidance