The Belarusian Government has addressed certain issues that arise in the practice of registering and circulating medical products. The corresponding resolution has been signed by Prime Minister Aleksandr Turchin.
The resolution “On Amending Resolutions No. 545 of the Council of Ministers of the Republic of Belarus of 18 September 2020, and No. 570 of 8 October 2021” provides for an expansion of the list of conditions under which, if any one is met, the Healthcare Ministry may apply a conditional registration procedure (for one year) for strategically important medical products. This is aimed at preventing shortages on the domestic market and reducing the number of unregistered medical products brought into the country.
The document also allows for the application of a simplified registration procedure (for five years) in cases where a product has already been registered by an authorized body of a Eurasian Economic Union member state.
The resolution also introduces changes to the procedure for issuing a pharmaceutical product certificate regarding the need to assess the information contained in the registration dossier - both for products included in the State Register of Medicinal Products of the Republic of Belarus and for those included in the Unified Register of Medical Products Registered in the Eurasian Economic Union.