RESOLUTION OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN

of March 15, 2017 No. 139

About approval of Regulations on procedure for passing of allowing procedures in system of the Public veterinary service

According to the laws of the Republic of Uzbekistan "About veterinary science" and "About allowing procedures in the field of business activity", for the purpose of further streamlining and simplification of procedures of issue of documents of allowing nature in system of the public veterinary service according to modern requirements the Cabinet of Ministers decides:

1. Approve:

Regulations on order of registration and issues of the registration certificate on the domestic and imported veterinary medicines and feed additives according to appendix No. 3;

Regulations on approval procedure for export, import and transit through the territory of the Republic of Uzbekistan of goods under control to the public veterinary service according to appendix No. 4.

2. Make changes to the List of documents of allowing nature in the field of business activity approved by the resolution of the Cabinet of Ministers of August 15, 2013 No. 225 (the joint venture of the Republic of Uzbekistan, 2013, No. 8, the Art. 55), according to appendix No. 5.

3. To the ministry of agricultural and water economy of the Republic of Uzbekistan together with the interested ministries and departments in a month:

bring the regulatory legal acts adopted by them into accord with this resolution;

approve the actions plan on extended coverage of the purposes, content and the practical importance of this resolution among subjects of business activity and to provide its realization at the scheduled time.

4. To impose control of execution of this resolution on the deputy prime minister - the minister of agricultural and water economy of the Republic of Uzbekistan Z.T.Mirzayev.

Appendix №1

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of March 15, 2017 No. 139

No. 86 voided according to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of 22.02.2022

Appendix № 2

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of March 15, 2017 No. 139

No. 86 voided according to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of 22.02.2022

Appendix №. 3

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of March 15, 2017 No. 139

Regulations on order of registration and issues of the registration certificate on the domestic and imported veterinary medicines and feed additives

Chapter 1. General provisions

1. This Provision according to the laws of the Republic of Uzbekistan "About veterinary science" and "About allowing procedures in the field of business activity" determines order of registration of the domestic and imported veterinary medicines and feed additives (further - veterinary medicines and feed additives) and issues of the registration certificate on veterinary medicines and feed additives.

2. Registration of veterinary medicines and feed additives, and also issue of the registration certificate are performed according to the scheme according to appendix No. 1 to this Provision.

3. The registration certificate is issued to the applicant with effective period for 5 years in form according to appendix No. 2 to this Provision.

The registration certificate is not the obligation on purchase of veterinary medicines and feed additives, and also the quality certificate.

4. In this Provision the following basic concepts are applied:

the applicant - the subject of entrepreneurship (the legal entity or individual entrepreneurs) who addressed to authorized body for the purpose of registration of veterinary medicines and feed additives and receipt of the registration certificate;

authorized body - the State committee of veterinary science of the Republic of Uzbekistan, the providing consideration of the application of the applicant, registration of veterinary medicines and feed additives and issue of the registration certificate;

the registration certificate - the document granting the right to implementation of production, realization, application and import to the territory of the Republic of Uzbekistan of veterinary medicines and feed additives.

5. Production, realization, application and import on the territory of the Republic of Uzbekistan of veterinary medicines and feed additives without receipt of the registration certificate is not allowed.

6. Requirements of Item 5 of this provision do not extend to the veterinary medicines and feed additives imported:

as pilot batches and samples for conducting examination;

within holding exhibitions, approbations and testing;

according to requests of state-financed organizations in case of emergency situations on especially dangerous infectious diseases of animals.

Chapter 2. Allowing requirements and conditions

7. Allowing requirements and conditions in case of production, realization, application and import on the territory of the Republic of Uzbekistan of veterinary medicines and feed additives are:

obligatory observance by the applicant of the legislation on veterinary science, regulating documents in the field of technical regulation, the data provided in registration documents of veterinary medicines and feed additives;

the notification of authorized body the owner of the existing registration certificate about changes and amendments in its registration documents, and also about the reasons of introduction of these changes and amendments with provision of exhaustive data on efficiency, harmlessness and indicators of quality of veterinary medicines and feed additives;

implementation of production of veterinary medicines and feed additives with ensuring biological safety in the territory of the republic according to the conclusion of the Central regime commission on studying of conditions of production of veterinary medicines under the State committee of veterinary science of the Republic of Uzbekistan;

timely elimination of the revealed shortcomings of registration documents.

Chapter 3. Documents and samples necessary for receipt of the registration certificate

8. For receipt of the registration certificate the applicant (or the authorized representative acting from his name) submits in authorized body the application in form according to appendix No. 3 to this Provision with appendix of the registration documents and samples necessary for registration of veterinary medicines and feed additives, according to appendix No. 4 to this Provision.

9. The requirement from the applicant of submission of documents and samples, not stipulated in Item the 8th this provision is not allowed.

10. The documents necessary for receipt of the registration certificate are represented by the applicant to authorized body 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.

At the same time the samples necessary for registration of veterinary medicines and feed additives are represented by the applicant directly or through means of mail service.

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

12. In case issue to the applicant of the registration certificate requires receipt of the documents and information which are available in other state bodies, the request is performed in the simplified procedure by the principle "one window" in case of which the authorized body receives the specified documents independently, without participation of the applicant.

13. The confidential information given in the documents submitted for receipt of the registration certificate shall not be disclosed by authorized body.

Chapter 4. Consideration of the application about issue of the registration certificate of veterinary medicines and feed additives. Issue of the registration certificate

14. The authorized body in time not exceeding three working days from the date of documents acceptance, stipulated in Item the 8th this provision, considers the documents submitted by the applicant regarding their compliance and sends them for consideration in accordance with the established procedure to the State scientific center of quality control and turnover of veterinary medicines and feed additives under the State committee of veterinary science of the Republic of Uzbekistan.

15. The state scientific center of quality control and turnover of veterinary medicines and feed additives under the State committee of veterinary science of the Republic of Uzbekistan in time which is not exceeding thirty working days performs:

conducting examination of the documents submitted for registration of veterinary medicines and feed additives;

assessment of conformity of requirements, shown to conditions of production of veterinary medicines and feed additives and control of their quality in the manufacturing organizations (if in the manufacturing organization international standards on compliance of quality of veterinary medicines and feed additives are implemented);

laboratory researches and receipt of analyses of veterinary medicines and feed additives;

efficiency analysis, harmlessness and quality of veterinary medicines and feed additives;

researches of samples of veterinary medicines and feed additives regarding compliance to requirements of regulating documents in the field of technical regulation regarding control of their quality and application of the offered methods of researches.

At the same time approbation and test works of veterinary medicines and feed additives are performed according to the program of testing approved by authorized body and approved with the applicant.

Implementation of the works provided in this Item is provided with authorized body by consideration of production of new, original veterinary medicines and feed additives. By consideration of production of earlier known veterinary medicines and feed additives (generics) the authorized body provides work only on examination of the documents of veterinary medicines and feed additives submitted by the applicant.

16. The authorized body in time which is not exceeding three working days from the date of documents acceptance, stipulated in Item the 8th this provision taking into account the conclusions of the State scientific center of quality control and turnover of veterinary medicines and feed additives and scientific technical council under the State committee of veterinary science makes the decision on registration of veterinary medicines and feed additives on issue of the registration certificate or on refusal in issue of the registration certificate.

17. The authorized body issues (sends) to the applicant the registration certificate or notifies the applicant in writing on refusal in issue of the registration certificate no later than one working day from the moment of adoption of the relevant decision in time.

18. For consideration of the application about issue of the registration certificate, and also work, stipulated in Item the 15th this provision, is levied collection in 10-fold size of minimum wage.

The amount of collection is credited into the account of the State scientific center of quality control and turnover of veterinary medicines and feed additives under the State committee of veterinary science.

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

The amount of collection for consideration of the application of the foreign producer (or the authorized representative acting from his name) about issue of the registration certificate, modification and amendments, issue of the duplicate, prolongation of effective period, renewal of the registration certificate is established by the State committee of veterinary science of the Republic of Uzbekistan within expense amount of the State scientific center of quality control and turnover of veterinary medicines and feed additives on implementation of the specified works.

19. For issue of the registration certificate collection in the amount of one basic settlement size is levied.

The amount of collection is credited on the bank account of authorized body.

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

submission of documents by the applicant, stipulated in Item 8th this provision, not in full;

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

discrepancy of the applicant to allowing requirements and conditions;

receipt of the motivated negative conclusion following the results of examination of documents, approbation and testing of samples of veterinary medicines and feed additives or other scientific and technical assessments.

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

22. In case of decision making about refusal in issue of the registration certificate the notification on refusal goes (is handed) to the applicant in writing including electronically through information system, with indication of causes of failure, specific regulations of the legislation and term during which the applicant, having removed the specified causes, can submit documents for de novo review.

The term during which the applicant has the right to remove causes of failure and to submit documents for de novo review, there cannot be less than ten working days from the date of receipt of the written or electronic notice of refusal in issue of the registration certificate.

23. In case of elimination by the applicant of the reasons which formed the basis for refusal in issue of the registration certificate, at the scheduled time de novo review of documents, issue of the registration certificate or refusal in its issue are performed by authorized body 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.

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

24. In case of de novo review of documents reduction from authorized body of the causes of failure which are earlier not stated in the notification to the applicant in writing, including electronically through information system, except for reductions of the causes of failure connected with the documents certifying elimination of earlier specified reasons is not allowed.

25. The application submitted by the applicant after the term specified in the written notice of refusal in issue of the registration certificate is considered again given and is considered by authorized body in accordance with general practice.

26. The applicant has the right to appeal in accordance with the established procedure the decision on refusal in issue of the registration certificate, and also action (failure to act) of the official of authorized body.

Chapter 5. Prolongation of effective period of the registration certificate

27. After effective period of the registration certificate it can be prolonged according to the statement of the applicant.

28. The application for prolongation of effective period of the registration certificate shall be submitted to authorized body in 90 days prior to expiration of the registration certificate.

29. Prolongation of effective period of the registration certificate is performed according to the procedure, provided for issue of the registration certificate.

Chapter 6. Renewal of the registration certificate and issue of the duplicate

30. In case of transformation of the applicant - the legal entity, change of its name or the location (postal address) the applicant or his legal successor shall within seven working days after passing of re-registration submit to authorized body the application for renewal of the registration certificate with application of documents, confirming the specified data.

31. In case of change of surname, name, middle name or the place of activities of the applicant - the physical person specified in the certificate on state registration granted to it, the applicant shall within seven working days after passing of re-registration submit to authorized body the application for renewal of the registration certificate with application of documents, confirming the specified data.

31-1. In case of merge of applicants - the legal entities having the registration certificate for date of state registration of again arisen legal entity renewal of the registration certificate according to the procedure, stipulated in Item the 30th this provision is allowed.

31-2. In case of change of the data containing in the registration certificate, in cases, which are not provided in Items 30, of the 31 and 311 this provision, renewal of the registration certificate is performed according to the statement of the applicant with appendix of the relevant documents.

32. Documents are submitted by the applicant to authorized body 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.

33. Before renewal of the registration certificate the applicant or his legal successor (heir) who submitted the application for renewal of the registration certificate makes or performs the action and (or) type of activity specified in it based on the submitted application for renewal of the registration certificate with mark of authorized body about date of reception of an application.

34. In case of renewal of the registration certificate the authorized body enters corresponding changes in the register of the issued registration certificates.

Renewal and issue of the registration certificate are performed no more than three working days from the date of receipt by authorized body of the statement for renewal of the registration certificate with appendix of the relevant documents in time.

35. The requirement from the applicant of the documents which are not provided by Items 30 and 31 of this provision is not allowed.

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

The authorized body shall issue (to direct) the duplicate of the registration certificate no more than three working days from the date of receipt of the statement, and also the original of the registration certificate in case of its spoil in time.

37. For consideration of the application about renewal of the registration certificate, issue of the duplicate of the registration certificate charges are not levied.

Chapter 7. Suspension, cancellation and cancellation of the registration certificate

38. Suspension, cancellation or cancellation of the registration certificate are made in cases and according to the procedure, 23 and 25 Laws of the Republic of Uzbekistan provided by Articles 22, "About allowing procedures in the field of business activity".

39. Treat the single gross violation of allowing requirements and conditions giving the grounds for the termination in accordance with the established procedure of action of the registration certificate damnification of life and to human health or animals as a result of implementation of activities on which right of implementation the registration certificate, or creation of real threat of causing such harm is issued.

Chapter 8. The register of the issued registration certificates

40. The authorized body keeps the register of the issued registration certificates and posts it on the official website.

41. In the register of the issued registration certificates the following main data are specified:

about applicants (the name of the applicant - for legal entities, their form of business, the location (postal address), phone; surname, name, the applicant's middle name - for physical persons, their passport data, the postal address, phone);

name of veterinary medicine and feed additive, form of their release, pharmakoterapevtichesky group and active ingredient;

country and name of the producer of veterinary medicines and feed additives;

dates of issue and number of the registration certificate;

bases and dates of renewal, suspension and renewal, prolongation of effective period of the registration certificate;

bases and date of cancellation of the registration certificate;

bases and dates of issue of duplicates of the registration certificate;

bases and date of cancellation of the registration certificate.

42. Information containing in registers of the issued registration certificates is open for acquaintance.

Chapter 9. Final provision

43. Persons guilty of violation of requirements of this provision bear responsibility according to the legislation.

Appendix №1

to Regulations on order of registration and issues of the registration certificate on the domestic and imported veterinary medicines and feed additives

Scheme of registration of veterinary medicines and feed additives, and also issues of the registration certificate

 

Appendix № 2

to Regulations on order of registration and issues of the registration certificate on the domestic and imported veterinary medicines and feed additives

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