A State Register of Manufacturer Selling Prices for Medicines has been established in Belarus. This is stipulated by Resolution of the Council of Ministers No. 776 of October 31, 2018, which was officially published today on the National Legal Internet Portal, BELTA reports.
A State Register of Manufacturer Selling Prices for Medicines has been established in Belarus. This is stipulated by Resolution of the Council of Ministers No. 776 of October 31, 2018, which was officially published today on the National Legal Internet Portal, BELTA reports.
The Register is a state information resource, which is an electronic database containing information on the maximum manufacturer selling prices for medicines.
According to the document, the Register will be formed by the Ministry of Health based on the Republican Unitary Enterprise "Center for Examinations and Drug Testing in Healthcare". The Center will be responsible for the development and modernization of the Register, its technical and software support, including automated consolidation of information included in the Register, its updating, storage, and protection.
The Register will be maintained on the principles of completeness and reliability of information, promptness, and compliance with organizational, software, technical, and methodological requirements.
The Register will be maintained electronically using an automated system by entering registry entries, which will contain the following information: the name of the marketing authorization holder for the medicinal product; the name of the manufacturer and the location of production sites; the name of the medicinal product; the number of the marketing authorization for the medicine; the dosage form indicating the dosage of the medicinal product and its quantity in the secondary packaging, as well as the completeness; the maximum manufacturer selling price in Belarusian rubles; the date and number of the Ministry of Health order on the registration of the maximum manufacturer selling price for the medicinal product, as well as the code of the medicinal product according to the Anatomical Therapeutic Chemical Classification system recommended by the World Health Organization.
The information contained in the Register will be open and accessible for public review.