Since 2016, Ukraine has implemented a simplified mechanism for state registration of certain medicinal products. This procedure contains a number of differences compared to the standard procedure for state registration of medical devices, in particular, related to documentation requirements, the scope and order of examination of registration materials and the terms of its completion.

From the point of view of legislation on the protection of economic competition, simplifying the procedure for entering the market of interchangeable drugs can have a positive effect on the development of competition in the market of drugs with the corresponding international non-proprietary name – INN of the active substance.

Simultaneously with the overall positive impact on the structure of the respective drug markets, the simplified procedure for individual drugs may create unequal conditions for manufacturers of interchangeable (analogous) drugs for their entry into the respective markets.

The Antimonopoly Committee of Ukraine continues to study the issue of the presence/absence of a negative impact of the introduced mechanisms of simplified drug registration on economic activity and appeals to drug market participants with a request to participate in the survey.

Published based on the materials of www.amc.gov.ua