Government Adopts Resolution On Drug Registration

The government of Belarus has adopted a resolution regulating certain aspects of the registration and circulation of medicines.

According to the Council of Ministers’ press service, the new document provides for:

• an expansion of the list of conditions under which the Health Ministry may apply a conditional registration procedure (for one year) for strategically important medicines in order to prevent shortages on the domestic market and reduce the volume of imported unregistered drugs;
• the possibility of applying a simplified registration procedure (for five years) in cases where a medicine is registered by an authorised body of a member state of the Eurasian Economic Union;
• amendments to the procedure for issuing a pharmaceutical product certificate, including the requirement to assess the information contained in the registration dossier both for medicines included in the State Register of Medicines of Belarus and those included in the unified register of registered medicines of the Eurasian Economic Union.