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Adoption of the List of active substances and their irrational combinations, the medical use of which as medicines is recognized as irrational
At its meeting on September 5, the Board of the Eurasian Economic Commission adopted the List of active substances and irrational combinations of active substances, the medical use of which as medicinal products is recognized as irrational.
The combination irrationality assessment and listing used the approaches of the ICH countries to the assessment of such combinations (including those employed in the European Union, the Republic of India, and the USA), taking into account the way such combinations mutually enhance the negative effects of active substances or cause resistance to antimicrobials regardless of the commercial component (sales of a medicinal product).
The document will make it possible to establish unified approaches to the assessment of marketing authorization applications for medicinal products by expert organizations when analyzing the effectiveness and safety of combined medicines and preventing such irrational combinations from going into circulation.
For pharmaceutical manufacturers, the use of a unified List will reduce the time and financial costs associated with the development of obviously irrational combinations.
