Order of the Government of the Russian Federation "About Modification of the Order of the Government of the Russian Federation of March 21, 2011 No. 181"

ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of November 2, 2024 No. 1481

About modification of the Order of the Government of the Russian Federation of March 21, 2011 No. 181

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made to the order of the Government of the Russian Federation of March 21, 2011 No. 181 "About procedure for import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors" (The Russian Federation Code, 2011, No. 13, Art. 1769; No. 51, Art. 7534; 2012, No. 15, Art. 1787; No. 37, Art. 5002; No. 40, Art. 5454; 2017, No. 2, Art. 375; No. 27, Art. 4052; 2018, No. 44, Art. 6740; 2020, No. 43, Art. 6808).

2. Recognize to invalid:

subitems "an" and "b" of Item of 152 changes which are made to acts of the Government of the Russian Federation concerning activities of the Ministry of Health of the Russian Federation, approved by the order of the Government of the Russian Federation of September 4, 2012 No. 882 "About introduction of amendments to some acts of the Government of the Russian Federation concerning activities of the Ministry of Health of the Russian Federation" (regarding modification, concerning according to Item 10 of the Regulations on import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors when implementing foreign trade activity with the State Parties of the Customs union within EurAsEC and Item 13 of the Regulations on import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors when implementing foreign trade activity with the states, not being members of the Customs union within EurAsEC, approved by the order of the Government of the Russian Federation of the Russian Federation of March 21, 2011 No. 181 "About procedure for import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors") (The Russian Federation Code, 2012, No. 37, the Art. 5002);

the order of the Government of the Russian Federation of September 26, 2012 No. 973 "About modification of the order of the Government of the Russian Federation of March 21, 2011 No. 181" (The Russian Federation Code, 2012, No. 40, the Art. 5454);

the paragraph of the sixth of the subitem "b" of Item 14 (in the part concerning Item 25 of the Regulations on import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors when implementing foreign trade activity with the states not being members of the Customs union within the EurAsEC approved by the order of the Government of the Russian Federation of March 21, 2011 No. 181 "About procedure for import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors") changes which are made to acts of the Government of the Russian Federation, approved by the order of the Government of the Russian Federation of June 27, 2017 No. 754 "About introduction of amendments to some acts of the Government of the Russian Federation" (The Russian Federation Code, 2017, No. 27, the Art. 4052);

the subitem "e" of Item of 3 changes which are made to the order of the Government of the Russian Federation of March 21, 2011 No. 181, approved by the order of the Government of the Russian Federation of October 18, 2018 No. 1242 "About modification of the order of the Government of the Russian Federation of March 21, 2011 No. 181" (The Russian Federation Code, 2018, No. 44, the Art. 6740).

3. This resolution becomes effective since March 1, 2025.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of November 2, 2024 No. 1481

Changes which are made to the Order of the Government of the Russian Federation of March 21, 2011 No. 181

1. In Regulations on import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors when implementing foreign trade activity with state members of the Eurasian Economic Union approved by the specified resolution:

a) state Item 5 in the following edition:

"5. The form of permission is established by the Ministry of Internal Affairs of the Russian Federation.

The Federal Service on supervision in the field of health care performs maintaining the register of the issued certificates in departmental information system of the Federal Service on supervision in the field of health care (further - the register of certificates). Data from the register of certificates are posted in open access on the official site of Service on the Internet with observance of requirements of the legislation of the Russian Federation on the commercial and protected by the law other secret.

Confirmation of availability of the certificate is entry in the register of certificates.

Registration number is assigned to the certificate with use of the unified register of the accounting of licenses (permissions) which is subsystem of the federal state information system "Federal Register of the State and Municipal Services (Functions)".

The statement is created of the register of certificates automatically in electronic form along with entering of record into the register of certificates and goes to personal account of the applicant in the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the single portal).

The two-dimensional bar code (QR code) by means of which transition to the page of the official site of the Federal Service on supervision in the field of health care on the Internet containing data from the register of certificates is provided is applied on the statement from the register of certificates.

Statement form from the register of certificates, form of the notification of the applicant of the made decision on refusal in issue of the certificate, the scope of information for inclusion in the register of certificates affirm the Federal Service on supervision in the field of health care.";

b) in Item 6:

in the offer the first "subitems "a" - "" of Item 9" shall be replaced with words words "paragraphs second and third Item 7 (1)";

the offer second to state in the following edition: "If concerning drugs, psychotropic substances or precursors temporary quantitative restrictions on import (export) are introduced, effective period of permissions and certificates is limited date of termination of the specified quantitative restrictions.";

c) state Item 7 in the following edition:

"7. For receipt of permission the applicant submits to the Ministry of Internal Affairs of the Russian Federation the application in writing on paper or electronically with use of personal account on the single portal or the information system "One Window" in the field of foreign trade activity (further - the One Window system).

For receipt of the certificate the applicant submits to the Federal Service on supervision in the field of health care the statement electronically with use of personal account on the single portal.";

d) add with Items 7 (1) and 7(2) following contents:

"7(1). Copies of the following documents are attached to the statements specified in Item 7 of this provision:

permission of competent authority of the import state to import to its territory of specific batch of the drugs which are under the international control according to the Single convention on the drugs of 1961, psychotropic substances which are under the international control according to the Convention on psychotropic substances of 1971, or the precursors which are under the international control in compliance the Convention of the United Nations on fight against illicit trafficking in drugs and psychotropic substances of 1988 (for precursors - in the presence of such permission at the importer);

the contract in foreign trade (agreement) concerning drugs, psychotropic substances or precursors with appendix of documentation (supplementary agreements, changes, amendments, amendments) and appendices which are integral part of the contract in foreign trade (agreement).

If the applicant is acted by the other person on behalf, for confirmation of powers use of the machine-readable power of attorney created including with use of the federal state information system "Single System of Identification and Authentication in the Infrastructure Providing Information and Technological Interaction of the Information Systems Used for Provision of the State and Municipal Services Electronically" is allowed.

The representative of the applicant has the right to submit on own initiative other documents confirming powers of the representative.

If the applicant is acted by the other person on behalf, also the power of attorney on the right of making of actions on behalf of the applicant signed by the head of the applicant or person authorized by it is attached to the statements specified in Item 7 of this provision, provided in writing on paper. If such power of attorney is signed by person authorized by the applicant's head also the document confirming powers of the specified person it is submitted to sign.

7(2). In case of import (export) of the drugs, psychotropic substances or precursors which are medicines, the applicant in addition to specified in paragraphs second and third Item 7 (1) this provision of copies of documents, in addition represents to the Federal Service on supervision in the field of health care the copy of the document confirming quality of drug, psychotropic substance or precursor.

If the drugs planned to import (export), psychotropic substances or precursors which are medicines on the date of filing of application, the Item 7 of this provision specified in the paragraph the second, are not made not made), the copy of the document confirming quality of drug, psychotropic substance or precursor is submitted in the Federal Service on supervision in the field of health care within 10 working days from the date of implementation of import (export).";

e) state Items 8 and 9 in the following edition:

"8. The statements specified in Item 7 of this provision in writing on paper are signed by the head of the applicant or other authorized person with indication of its position. The signature is deciphered with indication of surname and initials of the signing person and sealed the applicant (in the presence of seal). Persons assured by the signature of the head or other representative it who signed such applications and the applicant's seal (in the presence of seal) copies of the documents specified in Item 7 are enclosed to the specified applications (1) this provision.

The statements specified in Item 7 of this provision, and the copies of documents provided electronically attached to them are signed by the applicant (the applicant's representative) one of the following types of the digital signature:

the strengthened qualified digital signature;

the strengthened unqualified digital signature which certificate of key of check is created and is used in the infrastructure providing information and technological interaction of the information systems used for provision of the state and municipal services electronically in the procedure established by the Government of the Russian Federation on condition of the organization of interaction of physical person (in case of representation of interests of the applicant) with such infrastructure using the means of information protection which underwent in accordance with the established procedure assessment procedure of compliance.

9. In the statements specified in Item 7 of this provision are specified:

a) purposes of import (export) of drugs, psychotropic substances or precursors;

b) the name and the location address of the applicant, its primary state registration number (concerning the legal entities registered in accordance with the legislation of the Russian Federation) and identification taxpayer number (concerning the legal entities obliged to stay on the registry in tax authorities in accordance with the legislation of the Russian Federation), names and addresses of the locations of the producer and the consignee, and also the importer (in case of export implementation);

c) the name of drug, psychotropic substance or precursor specified in the list, the international non-proprietary name of drug or psychotropic substance, if any, or the first name under which it was issued or the name under which the specified drug or psychotropic substance, the name of precursor is issued;

d) dosage form of drug, psychotropic substance or precursor (if they are medicines);

e) amount of drugs, psychotropic substances or precursors in specific batch;

e) term of import (export) of drugs, psychotropic substances or precursors;

g) the country from which (in which) import (export) of drugs, psychotropic substances or precursors is performed;

h) mode of transport which is supposed to be used for import (export) of drugs, psychotropic substances or precursors, or method of their sending;

i) place and time of import (export) of specific batch of drugs, psychotropic substances and precursors;

j) number of entry in the register of licenses about provision of license for activities on drug trafficking, psychotropic substances and their precursors, to cultivation of the narcocontaining plants;

k) availability of the quality certificate of drug, psychotropic substance or precursor.";

e) in the offer the second Item 9 (the words "in the statement on receipt of permission" shall be replaced with words 1) "in the statement, the specified in paragraph one of Item 7 of this provision,";

g) declare Item 10 invalid;

h) in Item 11 of the word "to the statement" shall be replaced with words "to the statements specified in Item 7 of this provision";

i) Item 11 (to declare 1) invalid;

j) state Item 12 in the following edition:

"12. The Ministry of Internal Affairs of the Russian Federation makes the decision on issue or on refusal in issue of permission within 15 working days from the date of submission of the statement specified in paragraph one of Item 7 of this provision, and copies of the documents specified in Item 7 (1) this provision.

The Federal Service on supervision in the field of health care makes the decision on issue or on refusal in issue of the certificate within 5 working days from the date of submission of the statement specified in the paragraph the second Item 7 of this provision, and copies of the documents specified in Items 7 (1) and 7(2) this provision.";

k) in Item 13:

the paragraph one, subitems "an" and "b" to state in the following edition:

"13. The Ministry of Internal Affairs of the Russian Federation and the Federal Service on supervision in the field of health care (further - authorized bodies) refuse issue of permission or the certificate on the following bases:

a) availability of unreliable information in the statements specified in Item 7 of this provision, and copies of the documents specified in Items 7 (1) and 7(2) this provision provided by the applicant to the Ministry of Internal Affairs of the Russian Federation according to Items 7 and 7 (1) this provision and the Federal Service on supervision in the field of health care according to Items 7 - 7(2) this provision;

b) exhaustion of limit of drugs, psychotropic substances or precursors concerning which temporary quantitative restrictions on import (export), or introduction of temporary bans on import (export) of drugs, psychotropic substances or precursors are introduced;";

in the subitem "d" of the word "the subitem "an" of Item 9" shall be replaced with words "the paragraph the second Item 7 (1)";

l) Items 14 - 16 to state in the following edition:

"14. The decision of the Ministry of Internal Affairs of the Russian Federation on refusal in issue of permission with reasons for causes of failure is brought to the attention of the applicant in writing on paper within 5 working days from the date of adoption of such decision or electronically with use of personal account on the single portal or the One Window systems in day of adoption of such decision.

The decision of the Federal Service on supervision in the field of health care about refusal in issue of the certificate with reasons for causes of failure is brought to the attention of the applicant electronically with use of personal account on the single portal in day of adoption of such decision.

The decision on refusal in issue of permission or the certificate can be appealed in accordance with the legislation of the Russian Federation.

15. Permission cannot be transferred by the applicant to other legal entity. Modification of the issued document is not allowed.

16. In case of change of form of business, the name or the location address of the applicant permission is renewed after entering of the corresponding record into the Unified State Register of Legal Entities when giving in the Ministry of Internal Affairs of the Russian Federation of the statement for renewal of permission in writing on paper or electronically with use of personal account on the single portal or the One Window systems along with which the applicant has the right to provide on own initiative verified copies of the documents confirming the specified changes. In case of detection by the applicant of mistake in permission such permission is renewed by the Ministry of Internal Affairs of the Russian Federation according to the specified statement.

In case of loss of permission the duplicate of the specified document according to its application for issue of the duplicate of permission submitted to the Ministry of Internal Affairs of the Russian Federation in writing on paper or electronically with use of personal account on the single portal or the One Window systems is issued to the applicant.

Issue of the renewed permission or its duplicate is performed within 15 days from the date of registration of the corresponding application submitted by the applicant to the Ministry of Internal Affairs of the Russian Federation.

In case of change of form of business, the name or the location address of the applicant, the data in the register of certificates are adjusted automatically in case of their change in the Unified State Register of Legal Entities.

In case of detection by the applicant of mistake in information containing in the register of certificates, the Federal Service on supervision in the field of health care adjusts the specified information on the application for modification of the register of certificates submitted by the applicant to the Federal Service on supervision in the field of health care electronically with use of personal account on the single portal within 3 working days from the date of registration of such statement.";

m) in the subitem "b" of Item 18 of the word "the subitem "an" of Item 9" shall be replaced with words "the paragraph the second Item 7 (1)";

o) add Item 19 with the paragraph of the following content:

"The corresponding record is entered by the Federal Service on supervision in the field of health care within 3 working days from the date of the introduction in legal force of the judgment about cancellation of the license in the register of certificates.";

o) state Item 20 in the following edition:

"20. The decision of the Ministry of Internal Affairs of the Russian Federation on cancellation of permission is brought to the attention of the applicant in writing on paper within 5 working days from the date of adoption of such decision.

The decision of the Federal Service on supervision in the field of health care about cancellation of the certificate is brought to the attention of the applicant electronically by means of information and communication technologies in day of adoption of such decision.".

2. In Regulations on import to the Russian Federation and export from the Russian Federation of drugs, psychotropic substances and their precursors when implementing foreign trade activity with the states which are not members of the Eurasian Economic Union approved by the specified resolution:

a) in item 4 of the word "the Section II of Rules of issue of licenses and import permits and (or) commodity import (appendix to the Protocol on measures of non-tariff regulation concerning the third countries which is appendix No. 7 to the Agreement on the Eurasian Economic Union)" shall be replaced with words "Rules of issue of the licenses and import permits and (or) commodity import included in the single inventory to which measures of non-tariff regulation in trade with the third countries approved by the decision of Council of the Eurasian economic commission of November 24, 2023 No. 125 "About approval of Rules of issue of the licenses and import permits and (or) commodity import included in the single inventory to which measures of non-tariff regulation in trade with the third countries are applied" are applied;

b) state Item 8 in the following edition:

"8. The form of permission is established by the Ministry of Internal Affairs of the Russian Federation.

The Federal Service on supervision in the field of health care performs maintaining the register of the issued certificates in departmental information system of the Federal Service on supervision in the field of health care (further - the register of certificates). Data from the register of certificates are posted in open access on the official site of Service on the Internet with observance of requirements of the legislation of the Russian Federation on the commercial and protected by the law other secret.

Confirmation of availability of the certificate is entry in the register of certificates.

Registration number is assigned to the certificate with use of the unified register of the accounting of licenses (permissions) which is subsystem of the federal state information system "Federal Register of the State and Municipal Services (Functions)".

The statement is created of the register of certificates automatically in electronic form along with entering of record into the register of certificates and goes to personal account of the applicant in the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the single portal).

The two-dimensional bar code (QR code) by means of which transition to the page of the official site of the Federal Service on supervision in the field of health care on the Internet containing data from the register of certificates is provided is applied on the statement from the register of certificates.

Statement form from the register of certificates, form of the notification of the applicant of the made decision on refusal in issue of the certificate, the scope of information for inclusion in the register of certificates affirm the Federal Service on supervision in the field of health care.";

c) in Item 9:

in the offer the first "subitems "a" - "" of Item 12" shall be replaced with words words "paragraphs second and third Item 10 (1)";

the offer second to state in the following edition: "If concerning drugs, psychotropic substances or precursors temporary quantitative restrictions on import (export) are introduced, effective period of permissions and certificates is limited date of termination of the specified quantitative restrictions.";

d) state Item 10 in the following edition:

"10. For receipt of permission the applicant submits to the Ministry of Internal Affairs of the Russian Federation the application in writing on paper or electronically with use of personal account on the single portal or the information system "One Window" in the field of foreign trade activity (further - the One Window system).

For receipt of the certificate the applicant submits to the Federal Service on supervision in the field of health care the statement electronically with use of personal account on the single portal.";

e) add with Items 10 (1) and 10(2) following contents:

"10(1). Copies of the following documents are attached to the statements specified in Item 10 of this provision:

permission of competent authority of the import state to import to its territory of specific batch of drugs, psychotropic substances or precursors if it is stipulated by the legislation the relevant state, or the formal notice from this body that the specified permission is not required;

the contract in foreign trade (agreement) concerning drugs, psychotropic substances or precursors with appendix of documentation (supplementary agreements, changes, amendments, amendments) and appendices which are integral part of the contract in foreign trade (agreement).

If the applicant is acted by the other person on behalf, for confirmation of powers use of the machine-readable power of attorney created including with use of the federal state information system "Single System of Identification and Authentication in the Infrastructure Providing Information and Technological Interaction of the Information Systems Used for Provision of the State and Municipal Services Electronically" is allowed.

The representative of the applicant has the right to submit on own initiative other documents confirming powers of the representative.

If the applicant is acted by the other person on behalf, also the power of attorney on the right of making of actions on behalf of the applicant signed by the head of the applicant or person authorized by it is attached to the statements specified in Item 10 of this provision, provided in writing on paper. If such power of attorney is signed by person authorized by the applicant's head also the document confirming powers of the specified person it is submitted to sign.

10(2). In case of import (export) of the drugs, psychotropic substances or precursors which are medicines, the applicant in addition to specified in Item 10 (1) this provision of documents, in addition represents to the Federal Service on supervision in the field of health care the copy of the document confirming quality of drug, psychotropic substance or precursor.

If the drugs planned to import (export), psychotropic substances or precursors which are medicines on the date of filing of application, the Item 10 of this provision specified in the paragraph the second, are not made not made), the copy of the document confirming quality of drug, psychotropic substance or precursor is submitted in the Federal Service on supervision in the field of health care within 10 working days from the date of implementation of import (export).";

e) state Items 11 and 12 in the following edition:

"11. The statements specified in Item 10 of this provision in writing on paper are signed by the head of the applicant or other authorized person with indication of its position. The signature is deciphered with indication of surname and initials of the signing person and sealed the applicant (in the presence of seal). Persons assured by the signature of the head or other representative it who signed such applications and the applicant's seal (in the presence of seal) copies of the documents specified in Item 10 are enclosed to the specified applications (1) this provision.

The statements specified in Item 10 of this provision, and the copies of documents provided electronically attached to them are signed by the applicant (the applicant's representative) one of the following types of the digital signature:

the strengthened qualified digital signature;

the strengthened unqualified digital signature which certificate of key of check is created and is used in the infrastructure providing information and technological interaction of the information systems used for provision of the state and municipal services electronically in the procedure established by the Government of the Russian Federation on condition of the organization of interaction of physical person (in case of representation of interests of the applicant) with such infrastructure using the means of information protection which underwent in accordance with the established procedure assessment procedure of compliance.

12. In the statements specified in Item 10 of this provision are specified: