M WHO Guidelines on submission of documentation for the pilot procedure for prequalification of biotherapeutic products for human insulin - full assessment pathway PDF
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
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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
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
M WHO Guidelines on submission of documentation for the procedure for prequalification of similar biotherapeutic products PDF
M WHO prequalified quality control laboratory (QCL) annual report on activities (1 October 2016) DOCX
M WHO Procedure for Prequalification of Biotherapeutic Products or their corresponding Similar Biotherapeutic Products PDF
M WHO TRS 1003 Annex 3 - Procedure for assessing the acceptability in principle of quality control laboratories for use by the United Nations agencies PDF
IS M Withdrawal Notice - AmBisome Liposomal Amphotericin B 50mg Powder for Concentrate for Dispersion for Infusion (HA705) - Minisart® Filter PDF