Problems of Social Hygiene, Public Health and History of MedicineProblems of Social Hygiene, Public Health and History of Medicine0869-866X2412-2106Joint-Stock Company Chicot111410.32687/0869-866X-2022-30-6-1328-1330Научная статьяThe characteristics of restrictive listings of medications: the position of orphan medical preparationsKomarovI. A.iliya_komarov@mail.ruN. A. Semashko National Research Institute of Public Health151220223061328133021122022Copyright © 2022,2022In the Russian Federation, the regulations on making out restrictive listings of medications were established as separate Government Order in 2014. Since this moment, the procedure of listing revision underwent various changes. The last revisions of this legal document contained several amendments regarding orphan medications. So, in last version the rating scale included separate component related to these medications. This indicates at unique characteristics of orphan medications that not allow to consider them along with other medications. The article covers main stages of drug list forming procedures of making out restrictive listings of medications in the light of how available methodology is adapted to be applied to orphan medications.public healthhealth carerare diseasesorphan medicationslistingmedical carepatientslegal regulationобщественное здоровьездравоохранениередкие заболеванияорфанные лекарственные препаратыперечнимедицинская помощьпациентызаконодательствонормативно-правовое регулирование1.Taruscio D., Vittozzi L., Stefanov R. National plans and strategies on rare diseases in Europe. Ad. Exper. Med. Biol. 2010;686:475-91.2.Miller K. L., Lanthier M. Investigating the landscape of US orphan product approvals. Orphanet J. Rare Dis. 2018;183(13):1-8.