This was announced by the Deputy Head of Department for Social Sphere and Services of the Belarusian Ministry of Antimonopoly Regulation and Trade – Daria Orlova.
“It is assumed that the registration will be carried out by the Ministry of Health in agreement with the Ministry of Antimonopoly Regulation and Trade,” said Daria Orlova.
In addition, there will be a mechanism for re-registration of the maximum ex-works price for the drug (in case of an increase in prices for raw materials, etc.). This procedure will take less time than the registration.
Maximum ex-works prices will be determined in accordance with a specially elaborated methodology based on the reference pricing. In other words, they will take into account the information on manufacturer prices in countries similar to Belarus in terms of circulation of medicinal products. It is proposed that the procedure of registration would be set forth by a special decree of the Council of Ministers, which would specify the requirements for registration documents, period of their consideration, etc.
According to Daria Orlova, the mechanism for registration of maximum ex-works prices for medicines takes into account the experience of Russia and other countries.