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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of January 16, 2023 No. 7

About approval of regulations of ministerial procedures

(as amended on 26-04-2024)

Based on the paragraph of third of article 9-1 of the Law of the Republic of Belarus of October 28, 2008 No. 433-Z "About bases of ministerial procedures", subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446, the Ministry of Health of the Republic of Belarus DECIDES:

1. Approve:

The regulations of the ministerial procedure performed concerning subjects of managing on podpunktu1 9.14-1.1 "Receipt of permission to implementation of medical activities in the territory of the Chinese-Belarusian industrial park "Great Stone" (are attached);

The regulations of the ministerial procedure performed concerning subjects of managing according to subitem 9.14-1.2 "The admission" (are attached) by residents of the Chinese-Belarusian industrial park "Great Stone" of the unregistered medicines and medical products to medical application.

______________________________

1 For the purposes of this resolution the subitem is understood as the subitem of Item of the single list of the ministerial procedures performed concerning subjects of the managing approved by the resolution of Council of Ministers of the Republic of Belarus of September 24, 2021 No. 548.

2. This resolution becomes effective after its official publication.

Minister

D.L.Pinevich

It is approved

Ministry of Economics of the Republic of Belarus

 

Public institution "Administration of the Chinese-Belarusian industrial park "Great Stone"

 

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of January 16, 2023, No. 7

Regulations of the ministerial procedure performed concerning subjects of managing according to subitem 9.14-1.1 "Receipt of permission to implementation of medical activities in the territory of the Chinese-Belarusian industrial park "Great Stone"

1. Features of implementation of ministerial procedure:

1.1. the name of authorized body (jurisdiction of ministerial procedure) – public institution "Administration of the Chinese-Belarusian industrial park "Great Stone" (further, unless otherwise specified, – administration of the park);

1.2. the regulatory legal acts, the international agreements of the Republic of Belarus, the international legal acts containing the obligations of the Republic of Belarus regulating procedure of ministerial procedure:

The law of the Republic of Belarus "About bases of ministerial procedures";

The presidential decree of the Republic of Belarus of May 12, 2017 No. 166 "About enhancement of special legal regime of the Chinese-Belarusian industrial park "Great Stone";

the resolution of Council of Ministers of the Republic of Belarus of September 24, 2021 No. 548 "About the ministerial procedures performed concerning subjects of managing";

The instruction about procedure for the organization of maintenance and repair of medical equipment approved by the resolution of the Ministry of Health of the Republic of Belarus of October 3, 2006 No. 78;

1.3. other available features of implementation of ministerial procedure:

1.3.1. before decision making about issue of permission the administration of the park has the right to appoint conducting examination of compliance of opportunities of resident of public institution "Administration of the Chinese-Belarusian industrial park "Great Stone" (further, unless otherwise specified, – the industrial park) to perform medical activities;

1.3.2. appeal of the executive decision is performed judicially.

2. Documents and (or) data necessary for implementation of ministerial procedure:

2.1. represented by the interested person:

Name of the document and (or) data

Requirements imposed to the document and (or) data

Form and procedure for submission of the document and (or) data

Statement for issue of permission to implementation
medical activities

in form according to appendix

in writing:

during acceptance of the interested person;

by means of mail service; courier (courier)

The list of the works and services constituting the performed medical activities, and the list of procedures (researches, manipulations) relating to these works, services

affirms resident of the industrial park

The list of the methods of delivery of health care which are not approved to application

affirms resident of the industrial park with appendix of allowing documentation (registration, normative),
issued by authorized body (organization) of foreign state

The conclusion (act) of assessment of technical condition and results of works on metrological assessment and (or) commissioning of the declared works and services constituting medical activities belonging on the property right or other legal cause of medical equipment, products of medical appointment necessary for accomplishment (rendering)

it shall be issued by authorized body (organization)

Regulations for patients

shall be approved by resident of the industrial park

Copy of the staff list

The copy of the decision on appointment of person responsible for implementation of medical activities, and the statement from the order on its employment (position assignment)

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