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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
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M Stability testing of active pharmaceutical ingredients and finished pharmaceutical products - WHO Technical Report Series, No.1010, Annex 10, 2018 PDF Guideline/guidance
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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
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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
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IVD Technical Guidance Series (TGS) 1 - Standards applicable to the WHO Prequalification of in vitro diagnostic medical devices PDF Guideline/guidance
IVD Technical Guidance Series (TGS) 2 - Establishing stability of in vitro diagnostic medical devices PDF Guideline/guidance
IVD Technical Guidance Series (TGS) 4 - Test method validation for in vitro diagnostic medical devices Guideline/guidance
IVD Technical Guidance Series (TGS) 5 - Designing instructions for use for in vitro diagnostic medical devices PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 10 - In vitro diagnostic medical devices used for the qualitative and quantitative detection of Hepatitis C RNA Guideline/guidance
IVD Technical Specifications Series (TSS) 11 - In vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid Guideline/guidance
IVD Technical Specifications Series (TSS) 13 - Rapid diagnostic tests to detect hepatitis B surface antigen Guideline/guidance
IVD Technical Specifications Series (TSS) 14 - Immunoassays to detect hepatitis B virus surface antigen Guideline/guidance
IVD Technical Specifications Series (TSS) 15 - In vitro diagnostic medical devices used for the quantitative detection of Hepatitis B DNA Guideline/guidance
IVD Technical Specifications Series (TSS) 16 - Hepatitis C rapid diagnostic tests for professional use and/or self-testing, 2021 update Report
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