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Requirements for the bioequivalence report.

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The report on the bioavailability and/or bioequivalence study shall be prepared in accordance with the requirements of the guideline ICH Topic E 3 CPMP/ICH/137/95 "Structure and Content of Clinical Study Reports" and the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials, approved by order of the Ministry of Health of Ukraine No. 690 dated 23.09.2009, as amended by Orders of the Ministry of Health No. 523 dated 12.07.2012, No. 304 dated 06.05.2014, No. 966 dated 18.12.2014, and shall comply with the requirements of the guidelines EMA CPMP/QWP/EWP/1401/98 Rev. 1 "Guideline on the investigation of bioequivalence", EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2** "Guideline on bioanalytical method validation".