Changes in the legislations guiding medicines circulations in Republic Belarus

On the 31st of December 2019 significant changes have been made to the procedure of medicines сirculation in the Belarus Republic:

  • “Gospharmnadzor” is to be established until May 1, 2020 as a state body responsible for pharmaceutical supervision and auditing of entities involved in medicines circulation at any stage (manufacture, release, storage, etc.).
  • 3-month accelerated registration procedure will be applicable for medicines authorised by the stringent Agencies of:
  • Australia, Austria, US, Canada, Switzerland, Japan, UK, Germany, Denmark, Netherlands, Sweden, Spain, Portuguese;
  • EMA under a centralized procedure for circulation in the abovementioned countries;
  • from now on warehouses will be a subject of EAEU GDP inspections;
  • the list of essential medicines which are subject of prices registration has been expanded.

Official text of the amendments could be found on the website: