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: http://pravo.by/