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

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
No. KR DSM-103
of October 12, 2021

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

Chapter 1. General provisions

      1. These Rules for the Public Service “Provision of Medicinal Products, Specialised 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, Specialised 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 realising 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, Specialised 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 a public service, including the characteristics of the process, the form and the result of the provision, as well as information, subject to the peculiarities of public service, shall be prescribed in the standard of public service “Provision of Medicinal Products, Specialised Therapeutic Products, Medical Devices for Certain Categories of Citizens” as per Annex 1 hereto (hereinafter - the Standard).

      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 authorised person.

      8. The time limit for the provision of the public service from the moment the Service Receiver submits documents to the healthcare organisation, as well as when applying through the portal, shall not exceed 3 (three) hours in compliance with the Standard.

      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.

  Annex 1
to the Rules for the Public Service
“Provision of Medicinal Products,
Specialised Therapeutic Products,
Medical Devices to Certain
Categories of Citizens”

Standard of the Public Service
“Provision of Medicinal Products, Specialised Therapeutic Products, Medical Devices to Certain Categories of Citizens”

1

Name of the service provider

Healthcare providers

2

Ways of providing the public service

1) the Service Provider (upon direct application of the Service Receiver);
2) e-government web portal www.egov.kz (hereinafter referred to as the portal).

3

Time of public service delivery

1) from the moment the Service Receiver submits the documents to the healthcare provider, as well as when applying through the portal - not more than 3 (three) hours;
2) maximum permitted waiting time for document delivery - thirty minutes;
3) maximum permissible service time of the Service Receiver - thirty minutes.

4

Form of public service delivery

Electronic (partly automated) and/or paper

5

Result of public service delivery

1) when directly addressed to the service provider - provision of medicinal products, specialised therapeutic products and medical devices to certain categories of citizens.
2) when accessing the portal - provision of medicinal products, specialised therapeutic products and medical devices to certain categories of citizens in the information viewer of the e-Government Personal Office;
3) a reasoned refusal to provide the service.

6

Form of provision and result of public service

Electronic (partly automated) and/or paper

7

The amount of the fee charged to the Service Receiver in the provision of a public service and the manner in which it is charged in cases stipulated by the legislation of the Republic of Kazakhstan

Free of charge

8

Work schedule

1) the Service Provider - Monday to Friday inclusive, as per the established working hours from 9:00 to 18:30, with a lunch break from 13:00 to 14:30, except Saturdays, Sundays and public holidays;
2) Portal - twenty-four hours a day, except for technical breaks related to repair work (when a service recipient applies after working hours, on weekends and public holidays under the Labour Code of the Republic of Kazakhstan, applications shall be accepted and results of public service delivery shall be delivered on the next working day after the end of working hours).

9

List of documents required for the provision of the public service

1) to the service provider:
an identity document on direct application or an electronic document from the digital document service (for identification purposes)
2) to the portal:
request electronically.
The service providers shall receive the digital documents from the digital document service via the implemented integration, subject to the consent of the document owner provided via the user's cellular subscriber number registered to the portal by transmitting a one-time password or by sending a short text message as a response to the notification.

10

Grounds for refusal of a public service established by the legislation of the Republic of Kazakhstan

1) the unreliability of a document submitted by the Service Receiver to obtain a public service and (or) the data (information) contained therein is established;
2) lack of attachment to a Service Provider offering medicinal products, specialised therapeutic products and medical devices to certain categories of citizens as part of the GVFMC and (or) the CSHI system on an outpatient basis.

11

Other requirements, considering the specifics of public service delivery, including electronic service delivery

The Service Receiver may receive the public service electronically through the Service Receiver's mobile subscription number registered on the portal by transmitting a one-time password or by sending a short text message as a response to the portal notification.
The Service Receiver may receive a public service electronically via the portal, subject to the availability of an electronic digital signature.
For people with disabilities, there will be a ramp, call button, tactile walkway for the blind and visually impaired, waiting room, counter with sample documents.
The Service Receiver may obtain information on the procedure and status of the public service from the Service Provider's information services as well as from the 1414 Call Centre, 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, specialised 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: