The Pharmacovigilance Directorate of the State Enterprise “State Expert Center of the Ministry of Health of Ukraine” (hereinafter – the Center) has begun work on preparing a draft of amendments to the Procedure for Pharmacovigilance, approved by order of the Ministry of Health of Ukraine of December 27, 2006 No. 898, registered with the Ministry of Justice of Ukraine on January 29, 2007 under No. 73/13340 (as amended by order of the Ministry of Health of Ukraine of September 26, 2016 No. 996) (hereinafter – the Procedure).
To implement the planned changes to the Procedure, a Working Group was established by order of the Center, and a plan of further work on implementing the change process was developed. The planned changes to the Procedure will be harmonized with current European requirements for the implementation of pharmacovigilance. A key aspect of the changes is the introduction in Ukraine of a single expert evaluation of the Periodic Safety Update Report for medicinal products by the international nonproprietary name (INN) of the active pharmaceutical ingredient or combinations of active pharmaceutical ingredients.
The Working Group included heads of the Center's structural units, research specialists – professors, Doctors of Medical Sciences, heads of departments and staff of the pharmacology departments of leading medical institutions of Ukraine.
The first meeting of the Working Group took place on July 28, 2020, where the goals and objectives for the planned changes were defined.
