M Public consultation on proposed financing model for WHO prequalification: summary of responses received (issued 2 June 2015) PDF
M Q&A: Submission of applications for prequalification of magnesium sulfate injection (6 October 2014) PDF
M Quality assessment training, Denmark, 18‒21 May 2014: Active pharmaceutical ingredient assessment: impurities
M Quality assessment training, Denmark, 18‒21 May 2014: Bioequivalence: general considerations and Q&A
M Quality assessment training, Denmark, 18‒21 May 2014: Good manufacturing practice issues in quality assessment
M Quality Assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2, Second updated edition, Good manufacturing practice and inspection PDF
M Quality Information Summary (QIS) of the Biotherapeutic Product (BTP) Approved by Stringent Regulatory Authority (SRA) - QIS-BTP-SRA DOCX
M Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Authority (SRA) (QIS-BTP-SRA) DOCX
M Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA) (QIS-BTP-SRA) DOCX
M Quality information summary (QIS) of the finished pharmaceutical product (FPP) approved by the reference stringent regulatory authority (SRA) (QIS-SRA) (28 October 2013) DOCX
M Recommendations on the content of a survey protocol: Survey of the quality of antimalarial medicines PDF
M Recommended comparator products: medicines for infections in newborns and young infants and childhood pneumonia PDF
M Recommended comparator products: Treatment of multi-drug resistant bacterial infections (9 January 2024) PDF
M Règles OMS de bonnes pratiques applicables par les laboratoires de contrôle qualité pharmaceutique - TRS 957 - Annex 1 PDF
M Report on post-registration actions in respect of a product registered under the procedure, Appendix 4 PDF
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
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
M Requirements for provision of a ‘bridging’ report for SRA-approved medicines for consideration of registration in non-SRA settings, Annex 8 DOCX
M Screening checklist for biotherapeutic products and their corresponding SBPs - Abridged Pathway DOCX
M Section guidance for part 3 — patient information leaflet (PIL) — of a WHO Public Assessment Report (WHOPAR) (24 October 2016) PDF
M Section guidance for part 4 — summary of product characteristics (SmPC) — of a WHO Public Assessment Report (WHOPAR) (25 October 2016) PDF