The regulator has changed the rules for importing medicines for medical use

The new version also sets out a block of justification for the quantity of imported drugs and pharmaceutical substances. Thus, the justification for the purposes of developing drugs, conducting scientific and other studies will be determined based on the needs of the preclinical study and provided in the form of a study plan containing the main tasks, methodology, procedures, statistical aspects, organization and planning of resources for the preclinical study (including its stages and parts), and calculations of the quantity of imported drugs required to conduct pharmacological and toxicological studies during the preclinical study of the drug.

Previously, this development goal was determined based on the technological scheme of production and the material balance, compiled according to the industrial regulations for the production of medicinal products or its draft, and was presented in the form of extracts from the industrial regulations and regulatory documentation containing information on the quantity of the medicinal product required to conduct quality tests for the relevant indicators, references to pharmacopoeial articles of the state pharmacopoeia, the pharmacopoeia of the Eurasian Economic Union (EAEU) or foreign pharmacopoeias and calculations of the expert institution carrying out the examination of medicinal products.

A rationale has also been introduced for the purposes of registration and examination of medicines intended for circulation in Russia or on the common market of the EAEU and for the implementation of state registration. The inclusion of pharmaceutical substances in the State Register of Medicines will be determined based on the needs for the drug when conducting a comparative dissolution kinetics test in vitro. Information will be presented in the form of extracts from technological instructions, regulatory documentation (on quality) with information on the amount of medicine required to conduct quality tests for the relevant indicators, references to pharmacopoeial articles and calculations of the expert institution.

In August 2024, the Government of the Russian Federation approved an order according to which the pre-trial appeal procedure became mandatory from September 1, 2024, when challenging the actions of state and municipal bodies related to the provision of a number of licenses and permits. The order affected disputes when Roszdravnadzor issues a certificate for the right to import (export) narcotic drugs, psychotropic substances and their precursors, permits for the use of medical devices intended for the diagnosis of diseases, and other aspects.

UPD: The news from September 26, 2024, about the Ministry of Health proposing to adjust the Rules for the import of medicines for medical use into the country, was amended in connection with the approval of the thematic resolution .