Is it necessary to submit paper adverse reaction report forms for medicinal products if the applicant submits the same reports to the e-mail of the State Expert Center of the MoH in electronic format?

The applicant must provide information on cases of adverse reactions to a medicinal product, vaccine, tuberculin, and/or lack of efficacy of a medicinal product, and/or an adverse event following immunization/tuberculin diagnostics to the Pharmacovigilance Department of the Center, in accordance with the requirements of Chapter 2 of the Section of the Procedure for Pharmacovigilance, approved by order of the Ministry of Health of Ukraine of 27 December 2006 No. 898, registered with the Ministry of Justice of Ukraine on 19 December 2016 under No. 1649/29779 (as amended by order of the Ministry of Health of Ukraine of 26 September 2016 No. 996).

The applicant may provide information on the specified cases to the Center's e-mail in the appropriate format (for example, pdf) at cioms@dec.gov.ua (for medicinal products) and sayenko@dec.gov.ua (for medical immunobiological preparations), or using https://aisf.dec.gov.ua/Account/LogOn, which eliminates the need to submit paper report forms.