The summary data on the safety of the medical use of the medicinal product in Ukraine for the period of validity of the latest registration certificate shall reflect: the number of adverse reactions, sales volume (completed at the request of the Center), and the medicinal product exposure indicator (the exposure indicator is specified in accordance with the indicator specified in section "Calculation of exposure and regimens of use" of the Addendum to the clinical data review in accordance with subparagraph 2.3 of paragraph 2 of Annex 15 to the Procedure for conducting expert evaluation of registration materials for medicinal products submitted for state registration (re-registration), as well as expert evaluation of materials on amendments to registration materials during the validity of the registration certificate, approved by order of the Ministry of Health of Ukraine dated 26 August 2005 No. 426, registered with the Ministry of Justice of Ukraine on 07 October 2015 under No. 1210/27655 (as amended by order of the Ministry of Health of Ukraine dated 23 July 2015 No. 460), or in section V "Assessment of exposure and regimens of use" of the latest generated periodically updated safety report of the medicinal product in accordance with the requirements of Annex 12 to the Procedure for pharmacovigilance, approved by order of the Ministry of Health of Ukraine dated 26 September 2016 No. 996).
Regulatory references: Annex 13 to the Procedure for Pharmacovigilance, approved by order of the Ministry of Health of Ukraine No. 898 of December 27, 2006, registered with the Ministry of Justice of Ukraine on December 19, 2016 under No. 1649/29779 (as amended by order of the Ministry of Health of Ukraine No. 996 of September 26, 2016).
