of February 17, 2023 No. 16-FZ
About features of legal regulation of the relations in spheres of health protection, compulsory medical insurance, drug circulation and address of medical products in connection with acceptance to the Russian Federation of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region
Accepted by the State Duma on February 14, 2023
Approved by the Federation Council on February 15, 2023
This Federal Law determines features of legal regulation of the relations in spheres of health protection, compulsory medical insurance, drug circulation and address of medical products in connection with acceptance to the Russian Federation of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region.
During the transition period established by the Federal constitutional Law of October 4, 2022 No. 5-FKZ "About acceptance to the Russian Federation of the Donetsk People's Republic and education as a part of the Russian Federation of the new subject - the Donetsk People's Republic", the Federal constitutional Law of October 4, 2022 No. 6-FKZ "About acceptance to the Russian Federation of the Luhansk People's Republic and education as a part of the Russian Federation the new subject - the Luhansk People's Republic", the Federal constitutional Law of October 4, 2022 No. 7-FKZ "About acceptance to the Russian Federation of the Zaporizhia region and education as a part of the Russian Federation the new subject - the Zaporizhia region", the Federal constitutional Law of October 4, 2022 No. 8-FKZ "About acceptance to the Russian Federation of the Kherson region and education as a part of the Russian Federation the new subject - the Kherson region" (further - transition period), the subject of federal state control (supervision) of quality and safety of medical activities, federal state control (supervision) in the field of drug circulation, the federal state control (supervision) of the address of the medical products, including of observance established by the legislation of the Russian Federation of mandatory requirements in spheres of health protection, drug circulation, the address of medical products, and also mandatory requirements, established by regulatory legal acts of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region is determined by the features of the organization and implementation in 2023 - 2026 of types of the state control (supervision), municipal control established according to the procedure, determined by the specified Federal constitutional Laws.
1. Persons having the entries into force of this Federal Law issued about one day in the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region and also in the territory of Ukraine the certificate of the specialist, and (or) the certificate on accreditation of the specialist, and (or) the document confirming assignment of qualification category on specialties which correspond to the specialties specified in nomenclatures of professions of the specialists having medical and pharmaceutical education, approved according to part 2 of article 14 of the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation" (further - nomenclatures of specialties of health and pharmaceutical workers) are allowed to implementation of medical activities and pharmaceutical activities.
2. The documents specified regarding 1 this Article including documents which effective period expires during the transition period are effective till January 1, 2026.
3. The certificates of the specialist and documents confirming assignment of qualification category on specialties which correspond to the specialties specified in nomenclatures of specialties of health and pharmaceutical workers are equated to the certificates of the specialist provided by part 1 of article 100 of the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation" in the corresponding specialty. Certificates on accreditation of the specialist in the specialty which corresponds to the specialty specified in nomenclatures of specialties of health and pharmaceutical workers are equated to the certificates on accreditation of the specialist provided by part 3.2 of article 69 of the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation" in the corresponding specialty.
4. Persons having the documents specified regarding 1 this Article are subject to accreditation of the specialist till January 1, 2026 according to the procedure, established by the legislation of the Russian Federation in the field of health protection.
5. Persons having other education who worked in the medical organizations of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region on the date of entry into force of this Federal Law and whose labor (official) obligations included implementation of medical activities are allowed to implementation of medical activities till January 1, 2026 in the presence of the education document and (or) qualification confirming education according to job evaluation catalogs in the field of health care and professional standards. Specified persons are subject to accreditation of the specialist till January 1, 2026 according to the procedure, established by the legislation of the Russian Federation in the field of health protection.
6. The persons having medical or pharmaceutical education, not working on the specialty more than five years can be allowed to implementation of medical activities or pharmaceutical activities according to specialty which corresponds to the specialty specified in nomenclatures of professions of the specialists having medical and pharmaceutical education, after training according to additional professional programs (programs of occupational retraining) and passings of accreditation of the specialist according to the procedure, established by the legislation of the Russian Federation in the field of health protection.
7. Pedagogical and the scientists having the certificates of the specialist, and (or) the certificate on accreditation of the specialist issued in the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region about day of entry into force of this Federal Law, and (or) the document confirming assignment of qualification category on specialties which correspond to the specialties specified in nomenclatures of specialties of health and pharmaceutical workers and performing practical training of students and the scientists having the documents specified regarding 1 this Article, and performing scientific research in the field of health protection about day of entry into force of this Federal Law having the right to perform medical activities. Specified persons are subject to accreditation of the specialist till January 1, 2026 according to the procedure, established by the legislation of the Russian Federation in the field of health protection.
8. Persons who swore oath of the doctor according to the legislation existing in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region about day of their acceptance to the Russian Federation are considered sworn oath of the doctor in accordance with the legislation of the Russian Federation in the field of health protection.
9. The federal executive body performing functions on development and realization of state policy and normative legal regulation in the field of health care (further - authorized federal executive body), establishes compliance:
1) specialties on which about day of entry into force of this Federal Law in the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region, and also in the territory of Ukraine certificates of the specialist, and (or) the certificate on accreditation of the specialist, and (or) the documents confirming assignment of qualification category, to the specialties specified in nomenclatures of specialties of health and pharmaceutical workers were issued;
2) positions of the health workers and pharmaceutical workers established about day of entry into force of this Federal Law in the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region and also in the territory of Ukraine, to the positions specified in the nomenclature of positions of health workers and pharmaceutical workers approved according to part 2 of article 14 of the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation";
3) the qualification categories appropriated according to the legislation existing about day of entry into force of this Federal Law in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, and also the legislation of Ukraine, to the qualification categories appropriated according to the procedure, approved by authorized federal executive body.
10. During the transition period the authorized federal executive body has the right to make the decision on determination of cases (conditions) in case of which persons can be allowed to implementation of medical activities and (or) pharmaceutical activities without certificate of the specialist or passing of accreditation of the specialist and (or) in the specialties which are not provided by the certificate of the specialist or accreditation of the specialist and also on establishment of features of carrying out accreditation of the specialist.
11. During the transition period in coordination with authorized federal executive body regulatory legal acts of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region features of the organization and delivery of health care can be established.
12. During the transition period in coordination with the federal executive body performing functions on normative legal regulation in the field of medical and sanitary providing workers of separate industries of economy with especially dangerous working conditions, regulatory legal acts of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region features of the organization of delivery of health care in the territories with physical, chemical and biological factors hazardous to health of the person included in the corresponding list approved by the Government of the Russian Federation can be established.
13. During the transition period medical care in the medical organizations located in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region will be organized and appears without clinical recommendations.
14. During the transition period the authorized federal executive body has the right to establish features of performing medical examinations, medical surveys and medical examinations (except for medico-social examination), including procedure for registration and form of medical certificates by results of the specified surveys, surveys and examinations.
15. The persons which are on forced treatment in the medical organizations giving mental health services in stationary conditions, and also hospitalized in the specified organizations in involuntary procedure are considered respectively being on forced treatment and receiving mental health services in involuntary procedure in accordance with the legislation of the Russian Federation.
16. Till March 1, 2024 in coordination with authorized federal executive body regulatory legal acts of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region features of licensing of medical activities, pharmaceutical activities and activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants can be established.
1. In the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region the address is allowed:
1) medicines, data on which contain in the state register of medicines in accordance with the legislation of the Russian Federation, and (or) medicines, data on which contain in the unified register of the registered medicines of the Eurasian Economic Union according to the international treaties and acts constituting the right of the Eurasian Economic Union;
2) the medicines for medical application which are not subject to registration in the territory of the Russian Federation in accordance with the legislation of the Russian Federation or the international treaties and acts constituting the right of the Eurasian Economic Union;
3) the unregistered medicines allowed to import to the Russian Federation in accordance with the legislation of the Russian Federation or the international treaties and acts constituting the right of the Eurasian Economic Union;
4) medicines, including the medicines for medical application made in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region till January 1, 2026.
2. Production of the medicines specified in item 4 of part of 1 this Article is allowed without any confirmation by state bodies of the Russian Federation:
1) based on the allowing documents issued about day of entry into force of this Federal Law by public authorities of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region, and also Ukraine;
2) based on the allowing documents issued by public authorities of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, applications for which receipt were submitted about day of entry into force of this Federal Law.
3. The allowing documents specified in part 2 of this Article (including documents which effective period expired about day of entry into force of this Federal Law), are effective till January 1, 2026, except as specified, if the regulatory legal acts specified in part 16 of article 3 of this Federal Law contain other provisions regulating action of the specified allowing documents.
4. In the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region storage, transportation, leave, realization, transfer, use of the medicines specified in item 4 of part of 1 this Article before the expiration of their validity, and also their destruction are allowed.
5. Storage, transportation, leave, use of the medicines which are not conforming to requirements of part of 1 this Article delivered in the medical organizations of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region about day of entry into force of this Federal Law, till the expiry date of such medicines and also their destruction are allowed.
6. Transfer to the medical organizations of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region, storage, transportation, leave of the medicines which are not conforming to requirements of part of 1 this Article delivered (taking into account observance of storage conditions and expiration dates) in the pharmaceutical organizations of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region about day of entry into force of this Federal Law, retail trade by them till the expiry date of such medicines, and also their destruction are allowed.
7. Till January 1, 2026 price regulation on the medicines for medical application specified in item 4 of part of 1 this Article is performed according to regulatory legal acts of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region. From the date of entry into force of this Federal Law the regulatory legal acts of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region governing the relations in the specified sphere are accepted in coordination with the authorized federal executive body and federal executive body performing functions on acceptance of regulatory legal acts and control of compliance with law in the field of state regulation of the prices (rates) for goods (services).
8. Implementation of 1 this Article of the medicines for medical application included in the list of vital and essential drugs specified in item 4 of part is performed at the prices calculated proceeding from the actual selling prices established by producers of medicines, and the extreme sizes of wholesale allowances and limiting retail allowances to the actual selling prices of the producers established by the regulatory legal acts specified in part 7 of this Article.
9. Till January 1, 2026 realization by the pharmaceutical organizations located in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, medicines for medical application which are not included in the list of the vital and essential drugs, medical products, other goods specified in part 7 of article 55 of the Federal Law of April 12, 2010 to No. 61-FZ "About drug circulation" delivered in the pharmaceutical organizations for the prices in foreign currency is performed in rubles. The price of acquisition of the specified medicines, medical products and other goods is recalculated in rubles on the official rate of the Central bank of the Russian Federation for the delivery date.
10. In the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region the address is allowed:
1) the medical products registered in the Russian Federation in accordance with the legislation of the Russian Federation or the international treaties and acts constituting the right of the Eurasian Economic Union;
2) the medical products which are not subject to registration in the territory of the Russian Federation in accordance with the legislation of the Russian Federation or the international treaties and acts constituting the right of the Eurasian Economic Union;
3) the unregistered medical products allowed to import to the Russian Federation in accordance with the legislation of the Russian Federation or the international treaties and acts constituting the right of the Eurasian Economic Union;
4) the medical products made in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region till January 1, 2026.
11. Production of the medical products specified in item 4 of part 10 of this Article is allowed based on regulating, technical and (or) operational documentation of the producer (manufacturer) without any confirmation by state bodies of the Russian Federation.
12. In the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region storage, transportation, realization, installation, adjustment, application, operation, including the maintenance provided by regulating, technical and (or) operational documentation of the producer (manufacturer) and repair of the medical products specified in item 4 of part 10 of this Article before the expiration of their service (expiration date), and also their utilization or destruction are allowed.
13. Storage, transportation, installation, adjustment, application, operation, including the maintenance provided by regulating, technical and (or) operational documentation of the producer (manufacturer) and repair of the medical products which are not conforming to requirements of part 10 of this Article which about day of entry into force of this Federal Law equipped the medical organizations of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, before the expiration of service (expiration date) of such medical products, and also their utilization or destruction are allowed.
14. Storage, transportation of the medical products which are not conforming to requirements of part 10 of this Article, delivered in the organizations performing retail trade about day of entry into force of this Federal Law and also retail trade by them are allowed.
15. Production of the medical products specified in item 4 of part 10 of this Article is performed without the requirements established by part 8.1 of article 38 of the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation".
16. Till January 1, 2026 in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region the address of the medical products specified in item 4 of part 10 of this Article without submission of data according to part 3.1 of article 96 of the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation" is allowed.
1. Till January 1, 2026 financial provision of rendering in the medical organizations subordinated to executive bodies of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, medical care within the program of the state guarantees of free rendering medical care to citizens is performed at the expense of means of the federal budget, budgets of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, and also means of Federal Compulsory Health Insurance Fund.
2. Financial provision of rendering in the medical organizations subordinated to executive bodies of the government of other subjects of the Russian Federation, and the medical organizations, functions and powers of founders concerning which perform the Government of the Russian Federation or federal executive bodies of medical care to the citizens of the Russian Federation, foreign citizens and persons without citizenship who are living in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region and did not receive the policy of compulsory medical insurance within the program of the state guarantees of free rendering medical care to citizens is performed at the expense of means of the federal budget according to the procedure, established by the Government of the Russian Federation.
3. Till January 1, 2024 financial provision of rendering in the medical organizations subordinated to executive bodies of the government of other subjects of the Russian Federation, medical care to the citizens of the Russian Federation, foreign citizens and persons without citizenship living in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region and insured on compulsory medical insurance within the program of the state guarantees of free rendering medical care to citizens is performed at the expense of means of the federal budget according to the procedure, established by the Government of the Russian Federation.
4. Financial provision of rendering the specialized, including high-technology, medical care provided by the medical organizations, functions and powers of founders concerning which perform the Government of the Russian Federation or federal executive bodies to the citizens of the Russian Federation, foreign citizens and persons without citizenship living in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region insured on compulsory medical insurance according to single requirements of the basic program of compulsory medical insurance is performed at the expense of means of Federal Compulsory Health Insurance Fund.
4.1. In 2025 financial provision of rendering the ambulance, including the fast specialized, medical care, primary health care included in the basic program of compulsory medical insurance, rendered by the medical organizations, functions and powers of founders concerning which perform the Government of the Russian Federation or federal executive bodies to the citizens of the Russian Federation, foreign citizens and persons without citizenship living in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region insured on compulsory medical insurance according to single requirements of the basic program of compulsory medical insurance is performed at the expense of interbudget transfers, the territorial funds of compulsory medical insurance of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region transferred from the budget of Federal Compulsory Health Insurance Fund to budgets.
5. In 2023 - 2025 the fixed term of submission of the notification on inclusion of the medical organization in the register of the medical organizations performing activities in the field of compulsory medical insurance, other than the term established by part 2 of article 15 of the Federal Law of November 29, 2010 No. 326-FZ "About compulsory medical insurance in the Russian Federation" can be regulatory legal acts of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region.
6. In 2025 the size of insurance premiums for compulsory medical insurance of the idle population in the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region is determined as the work of number of unemployed insured persons in the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region as of January 1, 2024 and rate of insurance premium for compulsory medical insurance of the idle population established by the Federal Law of November 30, 2011 No. 354-FZ "About the size and procedure of payments of rate of insurance premium for compulsory medical insurance of the idle population".
6.1. In 2025 payment of the insurance premiums for compulsory medical insurance of the idle population specified in part 6 of this Article is performed monthly from budgets of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region in the budget of Federal Compulsory Health Insurance Fund in the amount of one twelfth annual amounts of budgetary appropriations provided on the specified purposes by the laws on budgets of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region, calculated according to part 6 of this Article, in time no later than the 28th of the current calendar month. If the specified payment due date of monthly obligatory payment falls on the day recognized in accordance with the legislation of the Russian Federation in the output and (or) non-working holiday in the afternoon of the termination of payment due date of monthly obligatory payment the working day following it is considered.
6.2. In 2025 financial provision of delivery of health care, included in the basic program of compulsory medical insurance, to the citizens of the Russian Federation, foreign citizens and persons without citizenship living in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, insured on compulsory medical insurance in the medical organizations subordinated to executive bodies of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, and also in the medical organizations subordinated to executive bodies of the government of other subjects of the Russian Federation, according to single requirements of the basic program of compulsory medical insurance is performed at the expense of interbudget transfers, the territorial funds of compulsory medical insurance of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region transferred from the budget of Federal Compulsory Health Insurance Fund to budgets, according to the procedure, established by the Government of the Russian Federation. The procedure for finishing by territorial funds of compulsory medical insurance of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region of the specified budgetary appropriations to the medical organizations subordinated to executive bodies of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, and payment of the medical care provided by these medical organizations is established by authorized federal executive body.
6.3. The interbudget transfers specified in part 6.2 of this Article are provided on condition of payment of the insurance premiums for compulsory medical insurance of the idle population specified in part 6 of this Article from budgets of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region in the budget of Federal Compulsory Health Insurance Fund monthly in the amount of one twelfth annual amounts of budgetary appropriations provided on the specified purposes by the laws on budgets of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region, in time no later than the 28th day of every month.
6.4. In 2025 financial provision of delivery of health care, to the citizens of the Russian Federation, foreign citizens and persons without citizenship living in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, not being insured on compulsory medical insurance, in the medical organizations subordinated to executive bodies of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region which is not included in the basic program of compulsory medical insurance, and also medical care is performed within the budgetary appropriations of budgets of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region created including due to provision from the federal budget to budgets of the Donetsk People's Republic, the Luhansk People's Republic, The Zaporizhia region and the Kherson region of grants for equalization of level of fiscal capacity of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and the Kherson region and on support of measures for ensuring balance of budgets of the specified subjects of the Russian Federation.
6.5. In case of insufficiency of the budgetary appropriations received in the form of interbudget transfers, specified in parts 6.2 of this Article, financial provision of delivery of health care to citizens of the Russian Federation, to the foreign citizens and persons without citizenship living in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, insured on compulsory medical insurance in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region in the medical organizations subordinated to executive bodies of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, and also in the medical organizations subordinated to executive bodies of the government of other subjects of the Russian Federation according to single requirements of the basic program of compulsory medical insurance it is performed in 2024 and 2025 within the budgetary appropriations of budgets of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region transferred to budgets of the relevant territorial funds of compulsory medical insurance.
6.6. In 2025 financial provision of expenses on the medical care provided in the medical organizations subordinated to executive bodies of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region according to single requirements of the basic program of compulsory medical insurance, to the citizens of the Russian Federation, foreign citizens and persons without citizenship insured on compulsory medical insurance, living in other subjects of the Russian Federation is performed within the budgetary appropriations specified in Item 2 of part 6 of article 26 of the Federal Law of November 29, 2010 to No. 326-FZ "About compulsory medical insurance in the Russian Federation", according to the procedure, established by the Government of the Russian Federation.
6.7. In 2025 financial provision of delivery of health care by method of replacement kidney therapy in case of the chronic renal failure in out-patient conditions included in the basic program of compulsory medical insurance, to the citizens of the Russian Federation, foreign citizens and persons without citizenship living in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, insured on compulsory medical insurance in the medical organizations of non-state pattern of ownership participating in implementation of territorial programs of compulsory medical insurance of other subjects of the Russian Federation according to single requirements of the basic program of compulsory medical insurance is performed at the expense of interbudget transfers, the territorial funds of compulsory medical insurance of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region transferred from the budget of Federal Compulsory Health Insurance Fund to budgets, according to the procedure, established by the Government of the Russian Federation.
7. During the transition period territorial funds of compulsory medical insurance of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region perform powers of medical insurance companies according to part 11 of article 14 of the Federal Law of November 29, 2010 No. 326-FZ "About compulsory medical insurance in the Russian Federation".
1. During the transition period by the Government of the Russian Federation features of creation, development and operation of the state information systems in the field of health care of subjects of the Russian Federation, medical information systems of the medical organizations and information systems of the pharmaceutical organizations in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region can be established. Functions of the operator of the specified information systems can be transferred to the federal state institution subordinated to authorized federal executive body.
2. During the transition period the authorized federal executive body has the right to approve features of the organization of system of document flow in the field of health protection regarding maintaining medical documentation in the form of electronic documents.
1. Actions for the organization of purchases regarding collection of supply requisitions of medicines, consideration and approval of such requests for the purposes of providing in 2023 with medicines for medical application of persons specified in parts 9.2 - 9.4 articles 83 of the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation", being in the territories of the Donetsk People's Republic, the Luhansk People's Republic, the Zaporizhia region and Kherson region, and immunobiological medicines according to Item 2 of article 15 of the Federal Law of September 17, 1998 No. 157-FZ "About immunoprevention of infectious diseases" are held by authorized federal executive body till July 1, 2023.
2. Producers of the medicines specified in item 4 of part 1 of article 4 of this Federal Law within two months from the date of entry into force of this Federal Law represent to the federal executive body performing functions on coordination of activities in the field of drug circulation regarding production of medicines for medical application, electronically or on paper the notification on implementation of activities for production of medicines containing the following data:
1) complete and (if is available) reduced names, including trade name of the legal entity;
2) form of business of the legal entity (in the presence);
3) location address of the legal entity;
4) addresses of places of implementation of activities for production of medicines which are intended to be performed and (or) is performed by producer of medicines, and (or) other data which allow to identify the place of implementation of productive activity and are specified in need of amendment to the postal address of the producer of medicines or instead of it in case of its absence, with indication of phone number and the e-mail address of the producer of medicines;
5) the list of the medicines made (planned to production);
6) information on production volume of each made medicine in month and in year.
3. Producers of the medical products specified in item 4 of part 10 of article 4 of this Federal Law within two months from the date of entry into force of this Federal Law represent to the federal executive body performing functions on control and supervision in the field of health care, electronically or on paper the notification on implementation of activities for production of medical products containing the following data:
1) name of medical product;
2) the purpose of medical product established by the producer (manufacturer) of medical products;
3) type of medical product;
4) class of potential risk of application of medical product;
5) code of the All-Russian Product Classifier by types of economic activity;
6) the name and the location of the organization - producer (manufacturer) of medical product or surname, name and (if is available) middle name, the residence of the individual entrepreneur - the producer (manufacturer) of medical product;
7) address of production site or production of medical product, contact phone number, e-mail address;
8) production volume of medical product in month and in year.
1. This Federal Law becomes effective since March 1, 2023.
2. Provisions of parts 1 and 3 of Article 3 and article 11 of the Federal Law of July 31, 2020 No. 247-FZ "About mandatory requirements in the Russian Federation" are not applied to the regulatory legal acts of the Russian Federation establishing mandatory requirements and provided by this Federal Law.
President of the Russian Federation
V. Putin
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