ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of March 5, 2020 No. 230

About import to the Russian Federation specific batch of the unregistered medicines containing drugs or psychotropic substances for delivery of health care according to vital testimonies of the specific patient or group of patients

According to part 3.1 of Article 47 and Item 6 of article 48 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

1. Approve the enclosed Rules of import to the Russian Federation of specific batch of the unregistered medicines containing drugs or psychotropic substances for delivery of health care according to vital testimonies of the specific patient or group of patients.

2. Import of the unregistered medicines containing drugs or psychotropic substances according to this resolution is performed by the federal state unitary enterprise "Moscow Endocrine Plant".

3. Money on purchase, import and delivery to authorized organizations of specific batch of the unregistered medicines containing drugs or psychotropic substances, the federal state unitary enterprise "Moscow Endocrine Plant" is provided to the Ministry of Industry and Trade of the Russian Federation in the federal budget for the corresponding year.

4. Determine that issue and (or) use of the medicines which are not registered in the Russian Federation containing drugs or psychotropic substances are performed by the medical organizations in the presence of license for activities for drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants with indication of works (services) in use of the drugs and psychotropic substances entered in lists II and III of the list of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation in the medical purposes and to their storage based on decisions of the medical commissions of the medical organizations in which there are under medical observation patients, about appointment and use of the unregistered medicines containing drugs or psychotropic substances according to vital indications.

5. Authorized bodies of the executive authority of subjects of the Russian Federation in the field of protection of public health based on decisions of the medical commissions of the medical organizations on inefficiency or impossibility of application for the specific patient of other registered medicines including containing other active ingredients will organize distribution between the medical organizations of specific batch of the unregistered medicines containing drugs or psychotropic substances for the purpose of their issue and (or) application taking into account again revealed patients.

6. This resolution is effective till December 31, 2023.

Approved by the Order of the Government of the Russian Federation of March 5, 2020 No. 230

Rules of import to the Russian Federation specific batch of the unregistered medicines containing drugs or psychotropic substances for delivery of health care according to vital testimonies of the specific patient or group of patients

1. These rules establish procedure for import to the Russian Federation for specific batch of the unregistered medicines containing drugs or psychotropic substances, included in the list of the diseases and conditions and the corresponding medicines containing drugs and psychotropic substances, approved by the Ministry of Health of the Russian Federation for delivery of health care according to vital testimonies of the specific patient or group of patients (further - specific batch of narcotic or psychotropic medicines).

2. For import to the Russian Federation of specific batch of narcotic or psychotropic medicines by the company specified in Item 2 of the order of the Government of the Russian Federation of March 5, 2020 to No. 230 "About import to the Russian Federation to specific batch of the unregistered medicines containing drugs or psychotropic substances for delivery of health care according to vital testimonies of the specific patient or group of patients" allowing documents according to the procedure, No. 181 established by the order of the Government of the Russian Federation of March 21, 2011 "About procedure for import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors" shall be received.

3. Authorized bodies of the executive authority of subjects of the Russian Federation in the field of protection of public health based on decisions of the medical commissions of the medical organizations on inefficiency or impossibility of application for the specific patient of other registered medicines including containing other active ingredients, and need of import of certain unregistered medicine with indication of its international unlicensed (either chemical, or grouping) names, forms of release and quantity according to the procedure, No. 558 established by the order of the Government of the Russian Federation of July 26, 2010 "About procedure for distribution, leave and realization of drugs and psychotropic substances, and also leaves and realization of their precursors", create the summary request for specific batch of narcotic or psychotropic medicines proceeding from settlement requirement, having provided if necessary increase in settlement requirement at the size which is not exceeding 25 percent for the purpose of stock forming, also submit the summary request to the Ministry of Industry and Trade of the Russian Federation for inclusion in the plan of distribution of drugs and psychotropic substances, and also in the Ministry of Health of the Russian Federation.

3(1). Authorized bodies of the executive authority of subjects of the Russian Federation in the field of protection of public health quarterly, no later than the 10th following reporting quarter send information on availability of unclaimed quantity of the delivered specific batch of narcotic or psychotropic medicines to the Ministry of Industry and Trade of the Russian Federation.

3(2). In case of additional requirement for specific batch of narcotic or psychotropic medicines the authorized body of the executive authority of the subject of the Russian Federation in the field of protection of public health represents to the Ministry of Industry and Trade of the Russian Federation the summary request for receipt of additional quantity of specific batch of narcotic or psychotropic medicines with appendix of the guaranty letter about fee on its transportation by budget funds of the subject of the Russian Federation.

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