M Notification of outcomes of national registration procedure by the NRA, Appendix 3, Part C PDF Template
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M Outline of the content of an annual report on the activities of a prequalified quality control laboratory (QCL) (4 June 2016) PDF Guideline/guidance
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M PQT/MED reliance on the work of national regulatory agencies and regional regulatory systems – new pathways PDF Guideline/guidance
M PQT/MED-specific Annotations for the WHO guideline on Biopharmaceutics Classification System-based biowaivers PDF Guideline/guidance
M Préqualification des laboratories de contrôle de qualité. Procédure d'evaluation de l'acceptabilité, de principe, des laboratoires de contrôle qualité à l'usage des institutions des Nations Unies PDF Guideline/guidance
M Principles for prioritizing dossiers within the WHO Prequalification Team: medicines (27 October 2011) PDF Information note
M Procedure to enable national registration of products prequalified based on SRA approval through CRP-18-March-2025 PDF Guideline/guidance
M Procedure to enable prequalification products approved by SRAs for use outside the SRA region-18 March 2025 PDF Guideline/guidance
M Product Recall - Moxifloxacin 100mg Dispersible Tablets (TB342): Batch BMC5801A PDF Information note
M Public consultation on proposed financing model for WHO prequalification: summary of responses received Application form
M Public consultation on proposed financing model for WHO prequalification: summary of responses received (issued 2 June 2015) PDF Report
M Q&A: Submission of applications for prequalification of magnesium sulfate injection (6 October 2014) PDF Guideline/guidance
M Quality assessment training, Denmark, 18-21 May 2014: Prequalification overview and update Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Active pharmaceutical ingredient assessment: impurities Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Bioequivalence: general considerations and Q&A Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Good manufacturing practice issues in quality assessment Presentation
M Quality Assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2, Second updated edition, Good manufacturing practice and inspection PDF Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product (BTP) Approved by Stringent Regulatory Authority (SRA) - QIS-BTP-SRA DOCX Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Authority (SRA) (QIS-BTP-SRA) DOCX Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA) (QIS-BTP-SRA) DOCX Template
M Quality Information Summary (QIS) of the Finished Pharmaceutical Product (FPP) Approved by the Reference Stringent Regulatory Authority (SRA) DOCX Template
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 Template
M Quality Information Summary (QIS) of the FPP Approved by the Reference SRA for use outside of the SRA Region DOCX Template
M Recommendations on the content of a survey protocol: Survey of the quality of antimalarial medicines PDF Report