On approval of the Rules for the Public Service “Provision of Medicinal Products, Specialised Therapeutic Products and Medical Devices to Certain Categories of Citizens”

Updated Unofficial translation

Order of the Minister of Health of the Republic of Kazakhstan No. КR DSM-103 of October 12, 2021. Registered with the Ministry of Justice of the Republic of Kazakhstan on October 15, 2021 under No. 24765.

      Unofficial translation

      Under sub-paragraph 1) of Article 10 of the Law of the Republic of Kazakhstan “On Public Services” I HEREBY ORDER:

      1. That the attached Rules for the Public Service “Provision of Medicinal Products, Specialised Therapeutic Products and Medical Devices to Certain Categories of Citizens” shall be approved as per the Annex hereto.

      2. That, in the manner prescribed by the legislation of the Republic of Kazakhstan, the Department of Drug Policy of the Ministry of Health of the Republic of Kazakhstan shall:

      1) ensure the state registration hereof with the Ministry of Justice of the Republic of Kazakhstan;

      2) place this order on the website of the Ministry of Health of the Republic of Kazakhstan after its official publication;

      3) within ten working days of the state registration hereof with the Ministry of Justice of the Republic of Kazakhstan, provide to the Legal Department of the Ministry of Health of the Republic of Kazakhstan information on the implementation of the measures envisaged in sub-paragraphs 1) and 2) of this paragraph.

      3. That the Supervising Vice-Minister of Health of the Republic of Kazakhstan shall be responsible for the implementation of this Order.

      4. That this order shall be enforced ten calendar days after the date of its first official publication.

      Minister of Health
of the Republic of Kazakhstan
A. Tsoy

      “APPROVED BY”
Ministry of Digital Development,
Innovations and Aerospace Industry
of the Republic of Kazakhstan

  Annex
to Order of the
Minister of Health of the
Republic of Kazakhstan
№ KR DSM-103
of October 12, 2021

Rules for the Public Service “Provision of Medicinal Products, Specialized Therapeutic Products, Medical Devices to Certain Categories of Citizens”

Chapter 1. General provisions

      1. These Rules for the Public Service “Provision of Medicinal Products, Specialized Therapeutic Products, Medical Devices to Certain Categories of Citizens” (hereinafter – the Rules) have been developed in conformity with the Code of the Republic of Kazakhstan “On Public Health and the Health Care System” and sub-paragraph 1) of Article 10 of the Law of the Republic of Kazakhstan “On Public Services” (hereinafter referred to as the Law) and determine the procedure for the provision of the public service "Provision of Medicinal Products, Specialized Therapeutic Products and Medical Devices to Certain Categories of Citizens" (hereinafter referred to as the public service).

      2. Basic terms used herein:

      1) information system for the accounting of outpatient drug provision (hereinafter referred to as ISDP) - information system specified by the competent authority in the field of health care to automate the accounting of prescriptions, dispensing of goods to pharmaceutical providers or service providers for the accounting and sales within the guaranteed volume of free medical care (hereinafter referred to as the GVFMC) and in the compulsory social health insurance system (hereinafter referred to as the CSHI system);

      2) medical devices - materials, products, solutions, reagents, sets, kits used to provide medical care according to the functional purpose and manufacturer's instructions;

      3) public service - one of the forms of implementation of individual public functions performed individually upon application or without application by the recipient of the service and aimed at realizing their rights, freedoms and legitimate interests, providing them with appropriate tangible or intangible benefits;

      4) electronic digital signature (hereinafter referred to as EDS) - a complex of electronic digital characters, created by means of electronic digital signature and confirming the authenticity of an electronic document, its ownership and invariability of its content.

Chapter 2. Procedure for the provision of the public service “Provision of Medicinal Products, Specialized Therapeutic Products and Medical Devices to Certain Categories of Citizens”

      3. To obtain the service on provision of medicinal products, specialized therapeutic products, medical devices for certain categories of citizens in electronic form, a natural person (hereinafter - the Service Receiver) shall log in to his/her personal profile on the "e-government" web portal www.egov.kz (hereinafter - portal) via the Service Receiver's EDS or through the certified one-time password, in case of registration and connection of the Service Receiver’s subscriber number provided by the mobile network operator to the portal account and shall submit the application electronically.

      When the Service Receiver submits an application for a public service, the service recipient's “personal profile” shall display the status of acceptance of the request for a public service, as well as a notification.

      4. To obtain the public service on paper, the Service Receiver shall apply to the health care entity (hereinafter Service Provider), presenting an identity card or an electronic document from the digital document service (for identification purposes).

      5. The person in charge, appointed by the head of the Service Provider, shall verify the assignment of the service recipient to the service provider, identify the service recipient for the provision of the public service and take a decision on the provision of the public service or on a justified refusal of the public service.

      When an application is submitted electronically, the Service Provider shall obtain the identity document information from the relevant state information systems via the e-government gateway.

      6. The list of basic requirements for the provision of public services, including the characteristics of the process, the form and result of the provision, as well as information taking into account the specifics of the provision of public services, shall be provided in the list of basic requirements for the provision of public services "Provision of medicines, specialized medical products, medical devices to certain categories of citizens" in accordance with Annex 1 to these Rules (hereinafter referred to as the List).

      The Ministry of Healthcare of the Republic of Kazakhstan, within three working days from the date of approval or introduction of amendment to these Rules, shall update them and send them to the healthcare entities, the operator of the information and communication infrastructure of the "electronic government" and the Unified Contact Center.

      Footnote. Paragraph 6 – in the wording of the order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 03.04.2023 № 56 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).

      7. The Service Receiver shall receive medicinal products, specialised therapeutic products, medical devices based on prescriptions issued in the ISDP. Information on provided medicinal products, specialised therapeutic products, medical devices shall be obtained via ISDP in the Service Receiver's personal profile of the e-Government.

      The Service Provider shall process the request within fifteen minutes of receiving the request at ISDP.

      Based on the results of processing, information on provided medicinal products, specialised therapeutic products, medical devices for certain categories of citizens shall be issued in the form as per Annex 2 hereto or a reasoned response on refusal to provide a public service shall be sent to the Service Receiver's personal account in the form of an electronic document signed with EDS by the Service Provider's authorized person.

      8. The term for the provision of public services from the moment the service recipient submits documents to the healthcare organization, as well as when contacting through the portal, is no more than 3 (three) hours in accordance with the List.

      Footnote. Paragraph 8 – in the wording of the order of the acting Minister of Health of the Republic of Kazakhstan dated 03.04.2023 № 56 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).

      9. The Service Provider shall ensure that data on the provision of the public service “Provision of Medicinal Products, Specialised Therapeutic Products, Medical Devices to Certain Categories of Citizens” is entered into the information monitoring system so as to track the provision of public services as per sub-paragraph 11) of paragraph 2 of Article 5 of the Law.

Chapter 3. Procedure for appealing against decisions, actions (inaction) of the service provider and (or) its officials concerning the provision of public services

      9. A complaint about a decision, action (inaction) of the service provider regarding the provision of public services shall be filed to the head of the service provider and (or) to the competent body for assessment and quality control of public services as per the legislation of the Republic of Kazakhstan.

      Under paragraph 2 of Article 25 of the Law, a Service Receiver's complaint filed against the Service Provider shall be considered within five working days of its registration.

      A complaint by a Service Receiver to the competent authority for the assessment and control of the quality of public services shall be considered within fifteen working days of its registration.

      10. In cases of disagreement with the results of a public service rendered, the Service Receiver shall apply to the court in the manner prescribed by the legislation of the Republic of Kazakhstan.

      11. A complaint shall be filed with the service provider, whose decision, action (inaction) shall be appealed.

      The service provider, whose decision, action (omission) shall be appealed, no later than three working days from the date of receipt of the complaint shall send it and the administrative case to the body considering the complaint. At the same time, the service provider, whose decision, action (inaction) shall be appealed, has the right not to send a complaint to the body considering the complaint, if he makes a decision or other administrative action that fully meets the requirements specified in the complaint within three working days. Unless otherwise provided by the Law, an appeal to a court shall be allowed after a pre-trial appeal.

      Footnote. Paragraph 11 – in the wording of the order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 03.04.2023 № 56 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).

  Annex 1
to the Rules of provision
of public service
"Provision of medicinal means,
specialized medical products
products medical use, to individual categories of citizens"

List of basic requirements for the provision of public services "Provision of medicines, specialized medical products, and medical devices to certain categories of citizens"

      Footnote. Annex 1 – in the wording of the order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 03.04.2023 № 56 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).

1

Name of service provider

Health care subjects

2

Methods of public service provision

1) service provider (if the service recipient directly contacts);

3

Term of public service provision

2) web portal "e-government" www.egov.kz (hereinafter referred to as the portal).

4

Form of public service provision

1) Service provider: from the moment the service recipient shall submit documents to the service provider - no more than 3 (three) hours; the maximum allowed waiting time for the delivery of documents is thirty minutes; maximum service time of the service recipient is thirty minutes.

5

Result of public service provision

2) through the portal - from the moment of submission of the document no more than thirty (30) minutes.

6

The amount of payment charged from the service recipient in the provision of public services, and methods of its collection in cases provided for by the legislation of the Republic of Kazakhstan

Electronic (partially automated) and/or paper

7

Service provider, state corporation and information objects work schedule

1) service provider - from Monday to Friday inclusive, in accordance with the established work schedule from 9-00 to 18-30 with a lunch break from 13-00 to 14-30, with the exception of Saturdays, Sundays and holidays;
2) portal - around the clock, with the exception of technical breaks associated with repair work (when the service recipient applies after the end of working hours, on weekends and holidays in accordance with the Labor Code of the Republic of Kazakhstan, applications are accepted and the results of the provision of state services are issued on the next working day).

8

List of documents and information requested from the service recipient for the provision of public service

1) to the service provider: an identity document, upon direct request, or an electronic document from the digital document service (for identification).

9

Grounds for refusal to provide public services established by the legislation of the Republic of Kazakhstan

2) to the portal: request in electronic form. Service providers shall receive digital documents from the digital document service through the implemented integration, subject to the consent of the owner of the document provided through the user's registered cellular subscriber number by transmitting a one-time password or by sending a short text message as a response to the notification.

10

Other requirements, taking into account the specifics of the provision of public services, including those provided in electronic form

The service recipient can receive the state service in electronic form by means of the service recipient registered on the mobile communication subscriber number portal by transmitting a one-time password or by sending a short text message as a response to the portal notification.
The service recipient shall have the opportunity to receive a state service in electronic form through the portal, provided that there shall be the EDS. For people with disabilities, there is a ramp, a call button, a tactile track for the blind and visually impaired, a waiting room, and a rack with sample documents.
The service recipient shall have the opportunity to obtain information on the procedure and status of the provision of public services in the reference services of the service provider, as well as the Unified Contact Center "1414," 8-800-080-7777.

  Annex 2
to the Rules for the Public Service
“Provision of Medicinal Products,
Specialised Therapeutic Products,
Medical Devices to Certain
Categories of Citizens”
  Document form

Information on medicinal products, specialized therapeutic products and medical devices provided to certain categories of citizens

      1. IIN:

      2. Full name:

      3. Date of birth:

      4. Nosology name:

      5. Service Provider’s name:

      6. International non-proprietary name of the medicinal product:

      7. Trade name of the medicinal product:

      8. Date of prescription:

      9. Prescription number:

      10. Date the prescription is provided:

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