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RESOLUTION OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN

of May 12, 2017 No. 284

About measures for further enhancement of procedure for licensing of pharmaceutical activities

(as amended on 07-07-2020)

According to the resolution of the President of the Republic of Uzbekistan of February 14, 2017 "About measures for further enhancement of procedure for realization of medicines and products of medical appointment, licensing of pharmaceutical activities" the Cabinet of Ministers decides No. PP-2773:

1. Approve:

Regulations on procedure for licensing of retail sale of medicines and products of medical appointment according to appendix No. 1;

Regulations on procedure for licensing of pharmaceutical activities, except retail sale of medicines and products of medical appointment according to appendix No. 4;

The scheme of electronic information exchange when licensing pharmaceutical activities according to appendix No. 5.

2. Determine that:

the licenses for the right of implementation of retail sale of medicines and products of medical appointment which are earlier granted by the Ministry of Health of the Republic of Uzbekistan are effective before the expiration of their action;

licenses for the right of implementation of retail sale of medicines and products of medical appointment are issued separately from licenses for the right of implementation of other directions of pharmaceutical activities and act on all territory of the Republic of Uzbekistan.

3. Ceased to be valid according to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of 07.07.2020 No. 429

4. To the Ministry of Health of the Republic of Uzbekistan:

in two weeks together with the Ministry of development of information technologies and communications of the Republic of Uzbekistan and other interested ministries and departments to make in the Cabinet of Ministers of the Republic of Uzbekistan offers on development and deployment of the database of registers of addresses and registers of workers of drugstores and branches which license was terminated owing to the revealed violations of the law, including for gross violation of procedure for pricing of medicines and products of medical appointment, and also determination of sources of covering of expenses for realization of the specified works;

in a month together with the interested ministries and departments to bring the regulatory legal acts and regulating documents adopted by them in the field of technical regulation into compliance with this resolution.

5. In the List of the licensing authorities performing licensing of separate types of activity, No. 236 approved by the resolution of the Cabinet of Ministers of June 28, 2002 (the joint venture of the Republic of Uzbekistan, 2002, No. 6, the Art. 36):

a) third the Section "Ministry of Health of the Republic of Uzbekistan" to state the paragraph in the following edition:

"Pharmaceutical activities (except retail sale of medicines and products of medical appointment)";

b) ceased to be valid according to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of 07.07.2020 No. 429

6. Recognize invalid some resolutions of the Cabinet of Ministers of the Republic of Uzbekistan according to appendix No. 6.

7. To impose control of execution of this resolution on the Minister of Health of the Republic of Uzbekistan A. K Shadmanov and It is information - analysis department concerning health care, ecology, environmental protection, physical culture and sport of the Cabinet of Ministers of the Republic of Uzbekistan.

Prime Minister of the Republic of Uzbekistan
Abdullah Aripov

Appendix № 1

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of May 12, 2017 No. 284

Regulations on procedure for licensing of retail sale of medicines and products of medical appointment

Chapter 1. General provisions

1. This Provision determines procedure for licensing of retail sale of medicines and products of medical appointment.

2. Licensing of retail sale of medicines and products of medical appointment is performed Territorial subdivisions of the Agency on development of pharmaceutical industry under the Ministry of Health of the Republic of Uzbekistan (further - the licensing body) in the place of state registration of the license applicant.

Licensing of retail sale of medicines and products of medical appointment is performed according to the scheme according to appendix No. 1 to this Provision.

3. Licensing of retail sale of medicines and products of medical appointment is performed through the Centers of the state services (further - the centers) or through the Single portal of interactive state services of the Republic of Uzbekistan (further - the Single portal).

4. Retail sale of medicines and products of medical appointment is performed only by drugstores and their branches.

5. On implementation of retail sale of medicines and products of medical appointment standard (simple) licenses are granted.

6. The license for implementation of retail sale of medicines and products of medical appointment (further - licenses) is issued for a period of five years.

The license can be granted for the term of less than five years only according to the statement of the license applicant.

7. Receipt of the license for implementation of retail sale of medicines and products medical prescription is not limited by the right of receipt of the license for other parts of pharmaceutical activities.

Transfer of the license or the rights on it is forbidden to other persons.

Chapter 2. Licensed requirements and conditions

8. Licensed requirements and conditions when implementing retail sale of medicines and products of medical appointment are:

a) obligatory compliance with law about medicines and pharmaceutical activities, and also requirements of regulating documents in the field of technical regulation in the field of drug circulation and products of medical appointment;

b) availability in staff of the legal entity at least one worker – the pharmacy manager having the higher pharmaceutical education and workers of drugstores, not vklyuchennoy in the register, whose license was terminated owing to the revealed violations of the law (further - the register of workers), including for gross violation of procedure for pricing of medicines and products of medical appointment;

c) when opening by the licensee of branch of drugstore - availability in staff of the legal entity at least one worker - the manager of branch of drugstore having the higher pharmaceutical education or secondary vocational professional education with specialty the assistant (assistant) to the druggist;

d) forming of personnel of drugstore, branch of drugstore from among the faces which are not included in the register of workers;

e) advanced training of the pharmacy manager and/or manager of branch of drugstore in accordance with the established procedure;

e) availability on the property right or other corporeal right of the building (room) conforming to the requirements provided in appendix No. 2 to this Provision, for implementation of retail sale of the medicines and products of medical appointment and which are not included in the register of addresses of drugstores and branches which license was terminated owing to the revealed violations of the law (further - the register of addresses) including for gross violation of procedure for pricing of medicines and products of medical appointment;

g) availability is material - the technical base conforming to the requirements provided in appendix No. 2 to this Provision;

h) the written notice of the licensing body of change of the pharmacy manager managing branch of drugstore, closing of branch of drugstore constituted in form according to appendix No. 3 to this Provision, within ten days from the date of approach of the specified cases;

i) payment of charges, the state fees in the cases, terms and the sizes established by this Provision.

j) conducting uninterrupted video fixing and storage within one month of videos of implementation process (leave) of medicines and products of medical appointment (except for drugstores and their branches located in the territory of rural family polyclinics and rural medical Items).

Chapter 3. Documents necessary for receipt of the license

9. For receipt of the license the license applicant represents to the center in attendance procedure or in electronic form through the Single portal the following documents:

the statement for licensing in form according to appendix No. 4 to this Provision (further - the statement);

the data confirming payment of collection for consideration of the application about licensing.

Instruction in the statement for licensing of the e-mail address of the license applicant is its consent to receipt of the notification on the made decision according to its statement electronically through the Single portal.

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

11. The licensing body independently obtains the documents and information, necessary for licensing, which are available in other authorized bodies in accordance with the established procedure according to the scheme of electronic information exchange when licensing the pharmaceutical activities determined by the Cabinet of Ministers of the Republic of Uzbekistan.

12. In case of the address in attendance procedure the employee of the center checks completeness of filling of the statement according to the passport of the state service approved by the licensing body in accordance with the established procedure.

After registration of a statement, the employee of the center issues to the license applicant the receipt on receipt of the statement or puts down the corresponding mark in the copy of the application, with indication of registration number of the statement.

13. The employee of the center in day of receipt of the statement in attendance procedure enters the data specified in the statement in special form which goes through the Single portal respectively to the licensing body.

14. In case of the address in attendance procedure to the center not in the location of the license applicant, the application is directed to the relevant licensing organ by the center through the Single portal.

In case of submission by the license applicant to the center of the statement on the electronic medium the employee of the center renders him, if necessary, assistance in the direction of the statement through the Single portal in the center, taken away for self-service.

15. The application directed through the Single portal is registered automatically with assignment of unique registration number.

Chapter 4. Consideration of the application and decision making about licensing or about refusal in licensing

16. For consideration of the application about licensing collection in the amount of two minimum wages, by the established legislation on the date of filing of application is levied from the license applicant. In case of submission of the statement for licensing along with opening of branch of drugstores, the established collection is levied for each opened branch.

For receipt of the license in case of the address through the Single portal 90 percent from the amount of the collection specified in paragraph one of this Item are levied.

17. In case of filing of application on licensing by the license applicant through the Single portal the collection amount for consideration of the application is credited:

Percent 11,25 - into the special account SUE Project Management Center of the Electronic Government and Digital Economy under the National Agency of Project Management in case of the President of the Republic of Uzbekistan in authorized bank;

10 percent - on personal account of off-budget fund of the Agency of the state services under the Ministry of Justice of the Republic of Uzbekistan;

the rest - into the account of the licensing body

In case of filing of application about licensing by the license applicant through the Single portal, means in the amount of 10 percent from the collection amount for consideration of the application are enlisted on personal account of off-budget fund of the Agency of the state services under the Ministry of Justice of the Republic of Uzbekistan, and the rest of means is enlisted into the account of the licensing body.

In case of the address in attendance procedure in the amount of 20 percent from the amount of the paid charges for consideration of the applications are enlisted in the centers, funds for personal account of off-budget fund of the Agency of the state services under the Ministry of Justice of the Republic of Uzbekistan in accordance with the established procedure.

18. The decision on issue or on refusal in licensing is accepted in time, not exceeding ten days from the date of receipt of the statement of the license applicant.

19. Ceased to be valid according to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of 07.07.2020 No. 429

20. The licensing body from the date of submission of the statement to the center:

within two days shall inform in writing the center by means of the Single portal on date and time, surname and initials of the authorized representative of the licensing body which is coming out to the location of the license applicant for studying of the license applicant on compliance to licensed requirements and conditions on form, according to appendix No. 5 to this Provision. At the same time the employee of the center without delay informs the license applicant on date and time of carrying out studying, and also the authorized representative of the licensing body;

within seven days considers the submitted documents and provides timely departure on locations of the license applicant, authorized representative who shall provide the official ID to the license applicant with explanation to it procedure for carrying out studying on compliance to licensed requirements and conditions. The authorized representative shall complete studying within one working day;

within ten days studies the license applicant on compliance to licensed requirements, with indication of about compliance or not compliance of the license applicant to licensed requirements and conditions, stipulated in Item the 8th this provision.

As authorized representatives highly qualified specialists of the corresponding profile and specialists of bodies of sanitary and epidemiological surveillance shall be involved.

21. Ceased to be valid according to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of 07.07.2020 No. 429

22. Ceased to be valid according to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of 07.07.2020 No. 429

23. Ceased to be valid according to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of 07.07.2020 No. 429

24. The licensing body within one working day from decision date about licensing or about refusal in licensing sends the notification on the made decision to the center (in case of its attendance address) or to the applicant (in case of the address in electronic form) through the Single portal in electronic form.

25. Notification:

about the made decision on licensing shall contain bank account details and payment due date of the state fee for licensing;

about refusal shall contain in licensing causes of failure, specific regulations of the legislation and term during which the license applicant, having removed the specified causes, can submit documents for de novo review.

The term during which the license applicant has the right to remove causes of failure and to submit documents for de novo review, shall be proportional to time necessary for elimination of causes of failure.

26. Licenses are drawn up by the licensing body, signed by the head of the licensing body, in case of its absence his deputy, and issued in accordance with the established procedure in three-day time after representation by the license applicant of the document confirming payment of the state fee.

In case of confirmation by the license applicant about observance of licensed requirements and conditions by putting down of all marks in the Section XI of appendix No. 4 to this Provision, signing of the license agreement is not required.

27. Licenses are drawn up on special forms.

The sample of the form of the license affirms the licensing body according to standard form of the form of the license provided by appendix No. 6 to this Provision.

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