Unofficial translation
In accordance with subparagraph 1) of Article 10 of the Law of the Republic of Kazakhstan dated April 15, 2013 "On Public Services", I HEREBY ORDER:
Footnote. Preamble - as amended by the order of the Minister of Healthcare of the Republic of Kazakhstan dated 05.01.2021 № ҚР ДСМ -2 (shall come into effect upon the expiration of twenty-one calendar days after the day of its first official publication).1. To approve the attached Rules for provision of the public service "Issuance of a license for medical activity".
2. The Committee for Control of Quality and Safety of Goods and Services of the Ministry of Health of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan, to ensure:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) placement of this order on the official Internet resource of the Ministry of Health of the Republic of Kazakhstan;
3) within ten working days after state registration in the Ministry of Justice of the Republic of Kazakhstan, submission of information to the Legal Department of the Ministry of Health of the Republic of Kazakhstan on implementation of the measures provided for in subparagraphs 1) and 2) of this paragraph.
3. The supervising Vice-Minister of Health of the Republic of Kazakhstan is authorized to control the execution of this order.
4. This order comes into effect upon the expiration of twenty one calendar days after the day of its first official publication.
|
Minister of health of the Republic of Kazakhstan |
Ye. Birtanov |
AGREED
Ministry of digital development,
innovations and aero-space industry
of the Republic of Kazakhstan
| Appendix to the order of the Minister of health of the Republic of Kazakhstan dated June 1, 2020 № ҚР ДСМ-59/2020 |
The Rules for the provision of the state service "Issuance of a license for medical activity"
Footnote. Annex - as amended by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated 09.03.2022 № ҚР ДСМ - 22 (shall come into effect sixty calendar days after the day of its first official publication).
Chapter 1. General Provisions
1. These Rules for the provision of public services "Issuance of a license for medical activities" (hereinafter referred to as the Rules) have been developed in accordance with Articles 73, 91 of the Administrative Procedural and Process-Related Code (hereinafter referred to as the APPRC), subparagraph 1) of Article 10 of the Law of the Republic of Kazakhstan "On Public Services "(hereinafter referred to as the Law) and shall determine the procedure for providing the state service "Issuance of a license for medical activities" (hereinafter referred to as the State service).
2. These Rules shall use the following concepts:
1) permitting control - the activities of licensing authorities aimed at verifying the applicant’s compliance with qualification or permitting requirements before issuing a permit and (or) annex to the permit, as well as ensuring compliance by licensees and holders of permits of the second category with the legislation of the Republic of Kazakhstan on permits and notifications after their issuance;
2) electronic digital signature – a set of electronic digital symbols created through an electronic digital signature and confirming the authenticity of the electronic document, its ownership and immutability of content (hereinafter referred to as EDS);
3) "electronic government" web portal - an information system that is a single window of access to all consolidated government information, including the regulatory legal framework, and to government services, services for issuing technical conditions for connecting to the networks of natural monopoly entities and services of quasi-state entities sector, provided in electronic form.
3. The public service shall be provided at the location of the service recipient.
4. The list of basic requirements for the provision of public services, including characteristics of the process, form, content and result of the provision, as well as other information taking into account the specifics of the provision of public services, shall be set out in the List of basic requirements for the provision of public services "Issuance of a license for medical activities" in accordance with Annex 1 to these Rules (hereinafter referred to as the List).
Footnote. Paragraph 4 - as amended by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated May 30, 2023 No. 91 (shall come into effect upon the expiration of sixty calendar days after the day of its first official publication).5. Payment of the license fee in the amount established by Article 554 of the Code of the Republic of Kazakhstan "On taxes and other obligatory payments to the budget (Tax Code)" shall be carried out in cash and non-cash form through second-tier banks and organizations carrying out certain types of banking operations, as well as through the payment gateway of the "electronic government" portal (hereinafter referred to as PGEG).
Chapter 2. The procedure for providing the state service "Issuance of a license for medical activities"
6. To carry out medical activities on the territory of the Republic of Kazakhstan, individuals or legal entities (hereinafter referred to as the Service recipient) shall send through the "electronic government" web portal www.egov.kz, www.elicense.kz (hereinafter referred to as the Portal) to the territorial departments of the Medical Committee and pharmaceutical control of the Ministry of Healthcare of the Republic of Kazakhstan (hereinafter referred to as the Service provider) applications in forms in accordance with Appendices 2 or 3 to these Rules with the attachment of documents established in paragraph 8 of the List and certified by an electronic digital signature.
Footnote. Paragraph 6 - as amended by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated May 30, 2023 No. 91 (shall come into effect upon the expiration of sixty calendar days after the day of its first official publication).7. On the day the documents are received, the service provider shall accept and register them.
If the service recipient applies after the end of working hours, on weekends and holidays, in accordance with the labor legislation of the Republic of Kazakhstan, the application shall be accepted and the result of the provision of public services shall be issued on the next working day.
8. The service provider from the digital document service through the implemented integration (hereinafter referred to as the Service), subject to the consent of the service recipient (document owner), provided through the user’s cellular subscriber number registered on the "electronic government" web portal by transmitting a one-time password or by sending a short text message as a response to a notification from the e-government web portal, shall receive the information:
1) about identity documents;
2) on state registration (re-registration) of the service recipient as a legal entity or individual entrepreneur;
3) on the availability of a license for medical activities and a license (Annex to the license for the relevant facility) for the use of devices and installations that generate ionizing radiation (if necessary);
4) certifying the right of ownership or a lease agreement, or an agreement for the gratuitous use of real estate (loan), or trust management of property, or a public-private partnership agreement (if the information is available in the "electronic government" gateway (hereinafter referred to as GEG));
5) on payment of the license fee (including for cases of re-issuance or receipt of a duplicate license (annex to it)) paid through PGEG, or second-tier banks and organizations carrying out certain types of banking operations;
6) on registration of a real estate property;
7) on the availability of higher medical education, for service recipients who completed their studies after 2015;
8) on the availability of secondary (technical and vocational), post-secondary medical education, for service recipients who completed their studies after 2015;
9) on a change of first name, patronymic (if any), last name or on marriage (matrimony) or dissolution of marriage (matrimony), for applicants who changed their first name, patronymic (if any), last name after receiving educational documents;
10) availability of a valid specialist certificate in the declared speciality;
11) on a document confirming the employee’s labor activity, according to the declared subtypes of activity in accordance with Article 35 of the Labor Code of the Republic of Kazakhstan (if the GEG contains information about the profiles of employees and accounting for employment contracts);
12) on the availability of a sanitary and epidemiological conclusion for the premises (building) in which it is planned to carry out medical activities (hereinafter referred to as the Production facility) (if available in the GEG).
Service provider from the information service of the Committee on Legal Statistics and Special Accounts of the General Prosecutor's Office of the Republic of Kazakhstan on the presence or absence of a ban on the implementation of medical and (or) pharmaceutical activities in the declared speciality or specialization (if the information is available in the service).
Footnote. Paragraph 8 - as amended by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated May 30, 2023 No. 91 (shall come into effect upon the expiration of sixty calendar days after the day of its first official publication).9. The completeness of the submitted documents specified in paragraph 8 of the List and information from the service received through the portal shall be checked by the service provider within 2 (two) working days from the date of registration of the documents.
If it is established that the submitted documents are incomplete in accordance with paragraph 8 of the List, and (or) documents have expired, the service provider, within the specified time frame, shall give a written reasoned refusal (in any form) in further consideration of the application, certified by the electronic digital signature of the authorized person of the service provider.
Footnote. Paragraph 9 - as amended by the order of the Minister of Healthcare of the Republic of Kazakhstan dated May 30, 2023 No. 91 (shall come into effect upon the expiration of sixty calendar days after the day of its first official publication).10. Upon provision of documents in full in accordance with paragraph 8 of the List, the service provider shall:
1) send, through the portal, to the territorial division of the state body in the field of sanitary and epidemiological welfare of the population- (hereinafter referred to as the Approving body) a request for approval of the issuance of a license and (or) annex to the license for medical activities;
2) conduct a hearing in accordance with Article 73 of the Arbitration Procedure Code;
3) carry out permitting control (before issuing a license) at the production facility of the first-time application for medical activities in accordance with the procedure in accordance with Article 51 of the Law of the Republic of Kazakhstan "On Permits and Notifications".
Footnote. Paragraph 10 - as amended by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated May 30, 2023 No. 91 (shall come into effect sixty calendar days after the day of its first official publication).11. The response on approval or refusal to approve the issuance of a license and (or) annex to the license for medical activities by the approving body shall be provided within 10 (ten) working days from the date of receipt of the request from the service provider.
12. The service provider, in accordance with Article 73 of the APPRC, shall provide the opportunity for the service recipient to express their position on a preliminary decision on an administrative case, about which the service recipient shall be notified in advance, but no later than three working days before the result of the provision of the public service (reasoned refusal).
The service recipient shall submit an objection to the preliminary decision no later than two working days from the date of its receipt.
If the service recipient verbally expresses their objection, the service provider shall maintain a hearing protocol, which they shall draw up in accordance with Article 74 of the Arbitration Procedure Code.
13. The service provider, in accordance with paragraph 2 of Article 21 of the Law, shall provide in an accessible form complete and reliable information on the list of required documents and the execution of such documents.
If there are comments, the service provider shall reason each comment with references to the structural elements of regulatory legal acts, and provide the opportunity for the service recipient to express their position.
14. Permit control shall be carried out in the order of preventive control with access to the object of control for the first time applying for medical activities.
Herewith, if medical activities are carried out at the production facility based on a license (annex to it), then upon receipt of an application from the service recipient for the issuance of an additional annex to the license, including in other specialities in accordance with paragraph 15 of the List of permits of the first category, approved by Annex 1 to According to the law, licensing control shall not be carried out at this production facility.
The service recipient shall be notified of the time and date of the visit to the control object by sending a text message to the subscriber's cellular number or the email address specified in the application, or using other means of communication that ensure the recording of the notice or call, at least one day before the start of the visit.
15. During licensing control (during a visit to the production facility), the service provider shall check the service recipient’s compliance with the qualification requirements, including the submitted documents and information, in accordance with paragraph 8 of the List.
Footnote. Paragraph 15 - as amended by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated May 30, 2023 No. 91 (shall come into effect sixty calendar days after the day of its first official publication).16. Permitting control shall be carried out using audio, photo or video recording; records are stored in the service provider’s internal information system "licensing portal".
17. The conclusion of the permitting control shall indicate the name of the service provider, data of the specialist who carried out the permitting control (last name, first name, patronymic (if any), place of work, position), data of the object of control (location address, business identification code or individual identification code, authorized person of the service recipient), as well as information on all points of the qualification requirements for medical activities, approved by Order of the Minister of Healthcare of the Republic of Kazakhstan dated October 22, 2020 No. ҚР-ДСМ-148/2020 "On approval of qualification requirements for medical and pharmaceutical activities" (registered in the State Register of Normative Legal Acts under No. 21502).
18. If the place where the service recipient carries out a subtype of medical activity is located in another administrative-territorial unit, the service provider who accepted the documents shall send a request and documents to the service provider at the place where the upcoming activity is carried out, for permitting control.
Herewith, the service provider, who will carry out permitting control, shall notify about the date and time of the site visit.
19. Terms of provision of public services:
from the moment the package of documents is submitted to the portal:
when issuing a license and (or) annex to the license - 13 (thirteen) working days;
when re-issuing a license and (or) annex to a license – 3 (three) working days;
when issuing a duplicate license and (or) annex to the license in case of loss or damage, issued in paper form - 2 (two) working days.
20. The result of the provision of a public service or a reasoned refusal to provide a public service, when the service recipient applies for obtaining, re-issuing a license and (or) annex to a license, as well as issuing a duplicate of a license and (or) annex to a license, shall be issued in electronic form, certified by the authorized digital signature of the service provider, is sent to the portal and stored in the "personal account" of the service recipient.
21. The service provider shall ensure that data is entered into the information system for monitoring the provision of public services in accordance with subparagraph 11) of paragraph 2 of Article 5 of the Law.
21-1. The Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan, within three working days from the date of making changes and (or) additions to these Rules, shall update information on the procedure for its provision and send information to the service provider, the operator of the information and communication infrastructure of "electronic government" and Unified contact center.
Footnote. The Rules are supplemented by paragraph 21-1 in accordance with the Order of the Minister of Healthcare of the Republic of Kazakhstan dated May 30, 2023 No. 91 (shall come into effect upon the expiration of sixty calendar days after the day of its first official publication).Chapter 3. The procedure for appealing decisions, actions (inaction) of service providers and (or) officials regarding the provision of public services
22. A complaint against decisions, actions (inaction) of the service provider and (or) their employees regarding the provision of public services shall be submitted to the head of the service provider.
23. A complaint from a service recipient received by a service provider directly providing a public service, in accordance with paragraph 2 of Article 25 of the Law of the Republic of Kazakhstan, is subject to consideration within five working days from the date of its registration.
24. When applying through the portal, information on the appeal procedure may be obtained by calling the Unified contact center for the provision of public services.
25. Pre-trial consideration of a complaint regarding the provision of public services shall be carried out by a higher administrative body, an authorized body for assessing and monitoring the quality of public services (hereinafter referred to as the Body considering the complaint) within fifteen working days from the date of its registration.
26. The complaint shall be submitted to the service provider whose decision, action (inaction) is being appealed.
The service provider, whose decision, action (inaction) is being appealed, no later than three working days from the date of receipt of the complaint, shall send it and the administrative file to the body considering the complaint.
In this case, the service provider, whose decision, action (inaction) is being appealed, shall have the right not to forward the complaint to the body considering the complaint if, within three working days, it makes a decision that fully satisfies the requirements specified in the complaint.
27. Unless otherwise provided by law, an appeal to the court shall be allowed after pre-trial appeal.
| Annex 1 to the Rules for the provision of public services "Issuance of a license for medical activities" |
List of basic requirements for the provision of the public service
"Issuance of a license for medical activities"
Footnote. Annex 1 - as amended by the order of the Minister of Healthcare of the Republic of Kazakhstan dated May 30, 2023 No. 91 (shall come into effect upon the expiration of sixty calendar days after the day of its first official publication).
1 | Name of the service provider | Territorial departments of the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan |
2 | Methods of providing public services | web portal "electronic government" www.egov.kz, www. elicense.kz (hereinafter referred to as the Portal) |
3 | Duration of provision of public services |
when issuing a license and (or) annex to the license - 13 (thirteen) working days; |
4 | Form of provision | electronic (partially automated) |
5 | The result of the provision of public services | license and (or) annex to a license, re-issuance of a license and (or) annex to a license, a duplicate of a license and (or) annex to a license for medical activities, or a reasoned response about a refusal to provide a public service |
6 | The amount of payment collected from the service recipient when providing a public service, and methods of collecting it in cases provided for by the legislation of the Republic of Kazakhstan |
The public service shall be provided for a fee, the following license fee shall be charged: |
7 | Work schedule of the service provider and information objects |
1) service provider - from Monday to Friday from 9.00 to 18.30 with a lunch break from 13.00 to 14.30, except weekends and holidays; |
8 | List of documents and information required from the service recipient for the provision of public services |
List of documents and information required for the provision of public services: |
9 | Grounds for refusal to provide public services established by the legislation of the Republic of Kazakhstan |
1) engaging in a type of activity is prohibited by the laws of the Republic of Kazakhstan for this category of individuals or legal entities, a branch of a foreign legal entity; |
10 | Other requirements taking into account the specifics of the provision of public services, including those provided in electronic form and through the State Corporation |
1. The service recipient shall have the opportunity to obtain information about the procedure and status of the provision of public services in remote access mode through the "personal account" of the portal, as well as a Unified contact center. |
| Annex 2 to the Rules for the provision of public services "Issuance of a license for medical activities" |
Form
Application by an individual to obtain a license and (or) annex to the license
To ______________________________________________________________
(full name of the licensor )
from____________________________________________________________
(last name, first name, patronymic (if any) of an individual, individual identification number
I hereby request to issue a license and (or) annex to the license to carry out
________________________________________________________________
(indicate the full name of the type of activity and (or) subtype (subtypes) of activity) on paper
media___________________________________________________________
(put an X if you need to obtain a license on paper)
Residence address of an individual____________________________________
________________________________________________________________
________________________________________________________________
(postal code, region, city, district, locality, street name,
house/building number (stationary premises)
Email___________________________________________________________
Phone numbers ___________________________________________________
Fax ____________________________________________________________
Bank account _____________________________________________________
(account number, name and location of the bank)
Address of the object of activity or actions (operations)
________________________________________________________________
(postal code, region, city, district, settlement, street name, house/building number (stationary premises)
_____ sheets attached.
It is hereby confirmed that:
1) all specified data are official contacts and any information on issues of issuing or refusing to issue a license and (or) annex to the license may be sent to them;
2) the applicant is not prohibited by the court from engaging in a licensed type and (or) subtype of activity;
3) all attached documents are valid;
4) the applicant agrees to the use of personal data of limited access, constituting a secret protected by law, contained in information systems, when issuing a license and (or) annex to the license.
Individual ____________ ___________________________________________
(signature) (last name, first name, patronymic (if any)
Date of completion: "_____"___________ 20_____.
| Annex 3 to the rules for the provision of public services "Issuance of a license for medical activities" |
Form
Application by a legal entity to obtain a license and (or) annex to the license
To ______________________________________________________________
(full name of the licensor)
from ____________________________________________________________
(full name, location, business identification number of a legal entity (including a foreign
legal entity), business identification number of a branch or representative office
of a foreign legal entity - if the legal entity does not have a business identification number)
I hereby request to issue a license and (or) annex to the operating license
________________________________________________________________
(indicate the full name of the type of activity and (or) subtype(s) of activity) on paper
media___________________________________________________________
(put an X if you need to obtain a license on paper)
Legal entity address ________________________________________________
________________________________________________________________
________________________________________________________________
(postal code, country (for a foreign legal entity), region, city, district, locality,
street name, house/building number (fixed premises)
Email ___________________________________________________________
Phone numbers ___________________________________________________
Fax _____________________________________________________________
Bank account _____________________________________________________
(account number, name and location of the bank)
Address of the object of activity or actions (operations)
_________________________________________________________________
(postal code, region, city, district, locality, street name, house number, building
(fixed premises). _____ sheets attached.
It is hereby confirmed that:
1) all specified data are official contacts and any information on issues of issuing
or refusing to issue a license and (or) annex to the license may be sent to them;
2) the applicant is not prohibited by the court from engaging in a licensed type
and (or) subtype of activity;
3) all attached documents are valid;
4) the applicant agrees to the use of personal data of limited access, constituting
a secret protected by law, contained in information systems, when issuing a license
and (or) annex to the license.
Supervisor ________ __________________________________
(signature) (last name first name patronymic (if any)
Date of completion: "_____" ___________ 20_____.