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LAW OF THE REPUBLIC OF BELARUS

of October 14, 2022 No. 214-Z

About change of the laws concerning health care, donorship of blood and its components

Accepted by the House of Representatives on September 20, 2022

Approved by Council of the Republic on September 26, 2022

Article 1. Bring in the Law of the Republic of Belarus of June 18, 1993 No. 2435-XII "About health care" the following changes:

1. To add article 2 after part two with part of the following content:

"The relations in the field of health care in the territory of the Chinese-Belarusian industrial park "Great Stone" are governed by the legislation on health care if other is not established by the legal acts regulating activities of the Chinese-Belarusian industrial park "Great Stone".".

2. To add paragraph two of Article 4 and part one of article 5 after words of "medical care" with the words "at the expense of public funds".

3. The paragraph the fourth article 32 parts four after the word "blood" to add with words of "its components".

4. The eleventh articles 46 after the paragraph of the fourth to add part with the paragraph of the following content:

"in the organization of service of blood according to the procedure and according to the list, the established Council of Ministers of the Republic of Belarus;".

Article 2. Item 1 of article 10 of the Law of the Republic of Belarus of July 15, 2010 No. 169-Z "About the objects which are only in property of the state, and types of activity to which implementation the exclusive right of the state extends" to add with subitem 1.10-1 of the following content:

"1.10-1. procurement and (or) realization of blood, its components;".

Article 3. No. 197-Z "About donorship of blood and its components" to be reworded as follows the law of the Republic of Belarus of November 30, 2010:

"LAW OF THE REPUBLIC OF BELARUS

About donorship of blood and its components

Chapter 1. General provisions

Article 1. The main terms used in this Law and their determinations

For the purposes of this Law the following main terms and their determinations are used:

autodonorstvo - the complex of actions including medical examination of the patient, blood extraction and (or) its components (further - blood, its components) at the patient in connection with the forthcoming carrying out concerning its difficult medical intervention which can be followed by blood loss, laboratory research, conversion, labeling, quality control, storage and transportation of blood, its components of the patient for the purpose of the subsequent transfusion to their this patient;

safety of blood, its components - set of properties and characteristics in case of which blood, its components do not pose hazard to life and health of the patient;

the auxiliary medical technologies applied in donorship of blood, its components (further - auxiliary medical technologies), - introduction in organism of the blood donor, its components (further - the donor) immunobiological medicines or erythrocytes (further - immunization of the donor), use of other medical technologies approved according to the procedure, established by the legislation;

mobile team on procurement of blood, its components (further - mobile team) - the structural division of the organization of service of blood performing procurement of blood, its components out of the organization of service of blood;

donation of blood, its components (further if other is not established, - donation) - complex of medical interventions on blood extraction, its components at the donor;

the donor - the patient who had medical examination and taking blood test, its components including the patient to whom auxiliary medical technologies are applied;

donor function - passing by the donor of medical examination, application concerning the donor of auxiliary medical technologies and (or) donation;

donorship of blood, its components (further - donorship) - complex of the actions aimed at providing and direct implementation of procurement of blood, its components;

unit (dose) of component of blood - blood component amount which can be, as a rule, made by conversion of one unit (dose) of blood;

unit (dose) of blood - 450 milliliters plus-minus of 10 percent of whole blood without amount of the preserving solution;

procurement of blood, its components - the complex of actions including medical examination of the donor, application concerning the donor of auxiliary medical technologies, donation, laboratory research, conversion, labeling and quality control of blood, its components;

karantinization - storage of components of blood with prohibition of their use on purpose throughout the period of time established by the legislation for the purpose of decrease in risk of transfer of pathogenic biological agents;

quality of blood, its components - compliance of blood, its components to the requirements established by acts of the legislation;

blood components - the blood components (leukocytes, plasma, platelets, erythrocytes) taken from the patient or made by conversion of blood of the patient and intended for medical application, industrial production of medicines productions of products of medical appointment, use in the scientific purposes and (or) educational process;

contract manufacturing of medicines from blood, its components (contractual fractionation) - industrial production of medicines based on the contract for contract manufacturing according to which the domestic manufacturer of medicines on the processing equipment belonging to it on the property right, economic maintaining, operational management or other legal cause makes medicines from blood, its components provided by the legal entity - the customer of production of such medicines, with the subsequent transfer of the made medicines to this legal entity - to the customer;

blood - the whole blood taken from the patient intended for medical application, conversion for the purpose of production of components of blood and also for industrial production of medicines, production of products of medical appointment, use in the scientific purposes and (or) educational process;

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