ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 1, 2021 No. 853

About approval of Rules of import of medicines for medical application to the Russian Federation and recognition voided some acts and separate provisions of some acts of the Government of the Russian Federation

According to part 1 of article 47 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

1. Approve enclosed:

Rules of import of medicines for medical application to the Russian Federation;

list of invalid acts and separate provisions of acts of the Government of the Russian Federation.

2. This resolution becomes effective since September 1, 2021. The rules approved by this resolution are effective till September 1, 2027.

Approved by the Order of the Government of the Russian Federation of June 1, 2021 No. 853

Rules of import of medicines for medical application to the Russian Federation

1. These rules establish procedure for import to the Russian Federation of medicines for medical application, except for medicines for the purpose of humanitarian assistance (assistance) or the help in case of emergency situations (further - medicines).

These rules do not extend to import of the drugs, psychotropic substances and their precursors included in the Section 2.12 "Drugs, Psychotropic Substances and Their Precursors" of the inventory concerning which the allowing procedure for import to customs area of the Eurasian Economic Union and (or) export from customs area of the Eurasian Economic Union (appendix No. 2 to the decision of Board of the Eurasian economic commission of April 21, 2015 No. 30 "About measures of non-tariff regulation"), in the list of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation, No. 681 approved by the order of the Government of the Russian Federation of June 30, 1998 "About approval of the list of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation" is established and in the nomenclature of the strong and toxic agents which are not precursors of drugs and psychotropic substances to which the procedure for import to the Russian Federation and export from the Russian Federation approved by the order of the Government of the Russian Federation of March 16, 1996 No. 278 extends approved by the order of the Government of the Russian Federation of August 3, 1996 No. 930.

2. The following legal entities can import medicines into the Russian Federation:

a) the organizations - producers of medicines - for the purposes of self-produced medicines;

b) organizations of wholesale trade by medicines;

c) foreign developers of medicines and foreign producers of medicines or other legal entities at the request of developer of medicine for performing clinical trials of medicine, registration and examination of the medicines intended for the address in the Russian Federation or in the total market of medicines within the Eurasian Economic Union, implementation of state registration of medicine, inclusion of pharmaceutical substance in the state register of medicines and quality control of medicines in the presence of the conclusion (the allowing document) processed by the Ministry of Health of the Russian Federation according to the decision of Board of the Eurasian economic commission of May 16, 2012 No. 45 "About single form of the conclusion (the allowing document) for import, export and transit of the separate goods included in the single inventory to which measures of non-tariff regulation in trade with the third countries, and methodical instructions for its filling are applied" (further - the conclusion);

d) the research organizations, the educational organizations of the higher education and producers of medicines - for development, researches, control of safety, quality and efficiency of medicines in the presence of the conclusion;

e) the medical organizations, and also the organizations specified in subitems "a" - "" of this Item, for delivery of health care according to vital testimonies of the specific patient or delivery of health care to the narrow contingent of patients with rare and (or) especially heavy pathology in the presence of the conclusion.

3. Import to the Russian Federation specific batch of the registered and (or) unregistered medicines intended for performing clinical trials of medicines, specific batch of the unregistered medicines for conducting examination of medicines for the purpose of registration and examination of the medicines intended for the address in the Russian Federation or in the total market of medicines within the Eurasian Economic Union, implementation of state registration of medicines, inclusion of pharmaceutical substance in the state register of medicines specific batch of the unregistered medicines for delivery of health care according to vital testimonies of the specific patient or for delivery of health care to the narrow contingent of patients with rare and (or) especially heavy pathology within activities of Fund of support of children with serious zhizneugrozhayushchy and chronic illness, including rare (orphan) diseases, "The good circle" (further respectively - specific batch of medicines, Fund) can be performed based on the conclusion according to statements of the legal entities specified in subitems "a" - "д" Item 2 of these rules.

Medicines can be imported into the Russian Federation for the purpose of, the these rules specified in Item 5.

4. Import to the Russian Federation of counterfeited, substandard, counterfeit medicines is forbidden.

5. Medicines for medical application can be imported into the Russian Federation for personal use and other non-commercial purposes without the conclusion if they are intended for:

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info