RESOLUTION OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN

of November 12, 2015 No. 330

About enhancement of procedure for import, export and transit through the territory of the Republic of Uzbekistan of drugs, psychotropic substances and precursors, and also control of their turnover

According to the laws of the Republic of Uzbekistan "About drugs and psychotropic substances", "About allowing procedures in the field of business activity" and the resolution of the Cabinet of Ministers of the Republic of Uzbekistan of August 15, 2013 "About measures for implementation of the Law of the Republic of Uzbekistan "About allowing procedures in the field of business activity" the Cabinet of Ministers decides No. 225:

1. Approve:

Regulations on procedure for passing of allowing procedures for receipt of the certificate on import, export of drugs, psychotropic substances and precursors according to appendix No. 1;

Regulations on procedure for passing of allowing procedures for receipt of permission to transit of drugs, psychotropic substances and precursors through the territory of the Republic of Uzbekistan according to appendix No. 2;

Regulations on procedure for passing of allowing procedures for receipt of permission to the right of the room of drugs, psychotropic substances and precursors on customs warehouse of the closed type according to appendix No. 3;

The list of drugs which turnover in the Republic of Uzbekistan is prohibited (List I), according to appendix No. 4;

The list of drugs which turnover in the Republic of Uzbekistan is limited (List II), according to appendix No. 5;

The list of psychotropic substances which turnover in the Republic of Uzbekistan is limited (List III), according to appendix No. 6;

The list of precursors which turnover in the Republic of Uzbekistan is limited (List IV), according to appendix No. 7.

2. To provide to state commission of the Republic of Uzbekistan on control of drugs strict control, and to the Council of Ministers of the Republic of Karakalpakstan, khokimiyats of areas and Tashkent, the State Customs Committee of the Republic of Uzbekistan interested to the ministries and departments to take necessary measures for observance by the subordinated organizations and other legal entities of established procedure of passing of allowing procedures for receipt of the certificate on import, export, permissions to transit through the territory of the Republic of Uzbekistan and permissions to the right of the placement on customs warehouse of drugs, psychotropic substances and precursors.

3. To the ministries and departments to bring the regulatory legal acts adopted by them into accord with this resolution.

4. Recognize invalid some decisions of the Government of the Republic of Uzbekistan according to appendix No. 8.

5. To impose control of execution of this resolution on the deputy prime minister of the Republic of Uzbekistan Ikramov A. I.

Appendix №1

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of November 12, 2015 No. 330

Regulations on procedure for passing of allowing procedures for receipt of the certificate on import, export of drugs, psychotropic substances and precursors

I. General provisions

1. This Provision according to the laws of the Republic of Uzbekistan "About drugs and psychotropic substances", "About allowing procedures in the field of business activity" and the resolution of the Cabinet of Ministers of the Republic of Uzbekistan of August 15, 2013 No. 225 "About measures for implementation of the Law of the Republic of Uzbekistan "About allowing procedures in the field of business activity" determines procedure for passing of allowing procedures for receipt of the certificate on import, export to the Republic of Uzbekistan of drugs, psychotropic substances and precursors (further - Scientific Production Enterprise) concerning which measures of the state control taking into account international treaties of the Republic of Uzbekistan are established.

2. Issue of the certificate on import, export of Scientific Production Enterprise (further - the certificate) is performed by Committee on control of drugs of Head department on quality control of medicines and medical equipment of the Ministry of Health of the Republic of Uzbekistan (further - Committee on control of drugs) under approval of Service of state security (further - SGB), the Ministry of Internal Affairs of the Republic of Uzbekistan (further - the Ministry of Internal Affairs) and to the relevant decision of State commission of the Republic of Uzbekistan on control of drugs (further - State commission) according to the scheme according to appendix No. 1 to this Provision.

3. Import and export of Scientific Production Enterprise are performed by legal entities (further - the applicant) in the presence of the certificate in form according to appendices No. 2 - 7 to this Provision.

4. The certificate is issued for a period of one year, except as specified, provided by the paragraph the second this Item.

When implementing import, export of certain amount of Scientific Production Enterprise several batches on each batch based on the statement of the applicant issue the separate certificate. At the same time the certificate is issued for the first batch for a period of one year, and on the second and the subsequent batches effective period of the certificate shall not exceed the effective period issued on the first batch.

5. Import and export of Scientific Production Enterprise is performed by the applicants having the license for the occupation right the activities connected with turnover of Scientific Production Enterprise issued by the Ministry of Health of the Republic of Uzbekistan.

6. Quarterly no later than the 25th following the accounting period, the State Customs Committee of the Republic of Uzbekistan submits the report in Committee on control of drugs and State commission on the actual import, export of Scientific Production Enterprise in form according to appendix No. 8 to this Provision.

7. The applicant in case of customs clearance of the imported and exported Scientific Production Enterprises represents to specially authorized bodies of the country importer/exporter, and also customs authorities original certificates.

8. Transfer of the Scientific Production Enterprise which are medicines in mailings, including international, is forbidden, except as specified, when they go as samples for registration or re-registration in the Republic of Uzbekistan of the medicines containing Scientific Production Enterprise.

9. Transfer by mail of Scientific Production Enterprise under the guise of the humanitarian assistance is forbidden, except as specified, when drugs or psychotropic substances go to particular legal entities of the Republic of Uzbekistan according to the conclusion of the Secretariat concerning education, health cares, cultures, youth, spirituality and public organizations, support waved also families of the Cabinet of Ministers of the Republic of Uzbekistan about belonging of the specified loads to the humanitarian assistance.

II. Allowing requirements and conditions

10. When passing allowing procedures for receipt of the certificate on import, export of Scientific Production Enterprise treat allowing requirements and conditions:

obligatory availability at the applicant of the license for the occupation right the activities connected with turnover of Scientific Production Enterprise;

obligatory compliance with law when implementing import, export of Scientific Production Enterprise;

the notification of Committee on control of drugs within seven working days after passing of re-registration about change of the name or the location (postal address) of the applicant.

III. Documents necessary for receipt of the certificate

11. For receipt of the certificate the applicant represents the following documents to Committee on control of drugs:

a) the statement for issue of the certificate on the official form of the applicant in form according to appendix No. 9 to this Provision;

b) copy of the contract for import or export of Scientific Production Enterprise;

c) when implementing export from the Republic of Uzbekistan Scientific Production Enterprise - the document of the importing country resolving import (the certificate, permission, the license for import or other allowing documents).

12. After adoption of documents for execution of the certificate the Committee on control of drugs independently obtains the following documents and information which are available in other authorized bodies by means of information exchange, including in electronic form:

a) the copy of the registration certificate of the medicine (in case as a part of medicine contain drugs and psychotropic substances) issued by Head department on quality control of medicines and medical equipment of the Ministry of Health of the Republic of Uzbekistan (further - Head department);

b) the copy of the license for the occupation right the activities connected with turnover of Scientific Production Enterprise, issued by the Ministry of Health of the Republic of Uzbekistan.

13. The requirement from the applicant of documents, not stipulated in Item the 11th this provision, is not allowed.

14. The documents necessary for receipt of the certificate are represented by the applicant to Committee on control of drugs directly, through means of mail service or electronically with the notification on their obtaining. The documents submitted electronically are confirmed by the digital signature of the applicant.

15. The documents submitted for receipt of the certificate are accepted according to the inventory which is without delay issued (goes) to the applicant with mark about date of documents acceptance.

IV. Consideration of the application and decision making about issue of the certificate or on refusal in its issue

16. The committee on control of drugs considers the application, issues or refuses issue of the certificate in time, not exceeding thirty working days from the date of reception of an application.

17. The committee on control of drugs creates document package and directs it for review with SGB and Ministry of Internal Affairs. After approval of SGB and Ministry of Internal Affairs the document package goes to State commission for receipt of the relevant decision.

In time, stipulated in Item the 16th this provision, approval of document package of SNB, the Ministry of Internal Affairs and receipt of the relevant decision of State commission joins.

18. For consideration by Committee on control of drugs of the statement and issue of the certificate collection in the amount of one minimum wage established by the legislation is levied. The amount of collection is credited on the bank account of the State center of examination and standardization of medicines of Head department (further - the State center).

In case of refusal the applicant from the submitted application for issue of the certificate the fee paid amount is not subject to return.

19. The committee on control of drugs issues to the applicant the certificate or notifies him in writing on refusal in issue of the certificate no later than one working day from the date of receipt by Committee on control of drugs of the corresponding conclusion of SGB, the Ministry of Internal Affairs (in case of refusal) and decisions of State commission.

20. Issue of the certificate on import, evacuation of the second and the subsequent batches of Scientific Production Enterprise is performed based on the statement of the applicant in time, not exceeding five working days from the date of reception of an application.

21. In the cases provided by the paragraph the second item 4 of this provision on the second and the subsequent batches of Scientific Production Enterprise the certificate is issued based on the statement of the applicant. At the same time for issue of each separate certificate collection in the amount of half of the minimum size of the salary established by the legislation is levied.

22. Issue of the certificate it can be refused on the following bases:

submission of the documents by the applicant necessary for issue of the certificate, not in full;

discrepancy of the applicant to allowing requirements and conditions;

representation following the results of studying of the reasonable negative conclusion of SGB or Ministry of Internal Affairs or the decision of State commission on impossibility of issue of the certificate;

availability in the documents submitted by the applicant, the doubtful or distorted data.

23. The refusal in issue of the certificate on other bases, including based on inexpediency, is not allowed.

In case of refusal in issue of the certificate the fee paid amount is not subject to return.

24. In case of decision making about refusal in issue of the certificate the Committee on control of drugs no later than one working day directs (hands) to the applicant the notification in writing with reasons for causes of failure and specific regulations of the legislation.

25. In case of elimination by the applicant of the reasons which formed the basis for refusal in issue of the certificate, de novo review of documents is performed by Committee on control of drugs in time, not exceeding ten working days from the date of receipt of the statement of the applicant for elimination of the causes of failure and the relevant documents certifying elimination of causes of failure.

26. In case of de novo review of the statement for issue of the certificate the refusal in issue of the certificate for the reasons which are earlier not specified in the notification on issue of the certificate is not allowed.

For de novo review of the statement of the applicant collection is not levied.

27. The applicant has the right to appeal in accordance with the established procedure refusal in issue of the certificate, and also action (failure to act) of the official of Committee on control of drugs.

V. Issue of duplicates of the certificate

28. In case of loss or spoil of the certificate according to the statement of the applicant its duplicate is issued.

The committee on control of drugs shall issue (to direct) the duplicate of the certificate no more than five working days from the date of receipt of the statement of the applicant, and also the document confirming introduction by the applicant of collection for issue of the duplicate of the certificate in time. In case of spoil of the certificate also its original is submitted.

29. For issue of the duplicate of the certificate collection in the amount of 10 percent of basic settlement size is levied. The amount of collection is credited on the bank account of the State center.

VI. Suspension, cancellation, renewal and cancellation of the certificate

30. Suspension (renewal), cancellation, renewal and cancellation of the certificate are made in the cases and procedure provided respectively by Articles 22 - 25 Laws of the Republic of Uzbekistan "About allowing procedures in the field of business activity".

31. For renewal of the certificate collection in half size of the amount of collection paid for consideration by Committee on control of drugs of the statement of the applicant for issue of the certificate is levied.

VII. The register of the issued certificates

32. The committee on control of drugs keeps the register of the issued certificates with placement it on the official website of Head department.

In the register of the issued certificates are specified:

name of the applicant, its form of business, postal address, phone;

date of issue and certificate number;

certificate effective period;

bases and dates of suspension and renewal of action of the certificate;

bases and date of cancellation of the certificate;

bases and date of renewal of permission to transit;

bases and date of cancellation of the certificate;

bases and dates of issue of duplicates of the certificate.

33. Information containing in registers of the issued certificates is open for acquaintance of legal entities and physical persons with it.

VIII. Final provision

34. Persons guilty of violation of requirements of this provision bear responsibility in the procedure established by the legislation.

Appendix №1

to Regulations on procedure for passing of allowing procedures for receipt of the certificate on import, export of drugs, psychotropic substances and precursors

The scheme of issue of certificates on import, export of drugs, psychotropic substances and precursors

Appendix № 2

to Regulations on procedure for passing of allowing procedures for receipt of the certificate on import, export of drugs, psychotropic substances and precursors

MINISTRY OF HEALTH OF THE REPUBLIC OF UZBEKISTAN COMMITTEE ON CONTROL OF MAIN THING DRUGS MANAGEMENTS ON QUALITY CONTROL OF MEDICINAL MEANS AND MEDICAL EQUIPMENT CERTIFICATE NO. 000001
on import of drugs
Makes sure present that the Committee on control of drugs of Head department on quality control of medicines and medical equipment to which application of the relevant laws on the drugs and their derivatives provided by the Single Convention of the UN on drugs of 1961 is assigned permits:
___________________________________________________________________________________________
(name of the import organization and its address)
____________________________________________________________________________________________
_______________________________________________________________________________
import to the Republic of Uzbekistan from ________________________________________________________________
			(name of the export organization and its address)
following drugs (international unlicensed name, dosage form, dosage, quantity):
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
The drugs specified in the certificate will be used for:
____________________________________________________________________________________________
____________________________________________________________________________________________
___________________________________________________________________________________________
____________________________________________________________________________________________
This certificate is valid to "____" _____________ 20 ___.
Chairman
Committee on control of drugs
"____" ______________ 20 ___.

(back)

COMMITEE ON LICIT DRUG CONTROL HEAD DEPARTMENT OF DRUGS AND MEDICAL EQUIPMENT QUALITY CONTROL PUBLIC HEALTH MINISTRY OF THE REPUBLIC UZBEKISTAN CERTIFICATE No. 000001
on the import of narcotics
This is to certify that Committee on Licit Drug Control Head department of drugs and medical equipment quality control entrusted with the application of laws on narcotics and their derivatives envisaged by 1961 UN Single Convention on Narcotics permits:
____________________________________________________________________________________________
(name and address importer)
____________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________
to import in Republic of Uzbekistan from ___________________________________________________________________________________________
(name and address exporter)
____________________________________________________________________________________________
____________________________________________________________________________________________
undermentioned narcotics (international nonproprietary name, pharmaceutical name, dosage, number):
________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
Above-stated narcotics are to be used in:
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
The certificate is valid up to "____" _____________ 20 __ at.
Chairman of the Licit
Drug Control Committee
"____" ________________ 20 __ at.

Appendix №. 3

to Regulations on procedure for passing of allowing procedures for receipt of the certificate on import, export of drugs, psychotropic substances and precursors

MINISTRY OF HEALTH OF THE REPUBLIC OF UZBEKISTAN COMMITTEE ON CONTROL OF MAIN THING DRUGS MANAGEMENTS ON QUALITY CONTROL OF MEDICINAL MEANS AND MEDICAL EQUIPMENT CERTIFICATE NO. 000001

on import of psychotropic substances

Makes sure present that the Committee on control of drugs of Head department on quality control of medicines and medical equipment to which application of the relevant laws on the psychotropic substances and their derivatives provided by the Convention of the UN on psychotropic substances of 1971 is assigned permits:

____________________________________________________________________________________________

(name of the import organization and its address)

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

________________________________________________________________________________________

import to the Republic of Uzbekistan from

____________________________________________________________________________________________

(name of the export organization and its address)

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