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LAW OF THE REPUBLIC OF MOLDOVA

of November 20, 2008 No. 241

About donorship and blood transfusion

(as amended on 08-11-2018)

The parliament adopts this organic law.

This law is drafted for the purpose of regulation and stimulation of voluntary donorship of human blood and its components, provision of complex of the social, legal, economic and medical rights to donors and recipients of components and medicines of blood, and also use of components and medicines of blood by medical and sanitary organizations.

Chapter I. General provisions

Article 1. Area of regulation

This law regulates:

a) the social, legal and economic relations directed to stimulation and the organization of donorship of human blood (daleekrov) and its components and also transfusions of those;

b) regulations on quality assurance and safety of donorship, conversion and use of blood and its components, including as raw materials for production of diagnostic and biomedical supplies, for the purpose of maintenance of high level of public health care.

Article 2. Legal basis

(1) the Legal basis of donorship and use of blood and its components are the Constitution of the Republic of Moldova, this law, the international agreements, one of the parties of which is the Republic of Moldova, other regulations regulating legal relations in the field.

(2) If international treaties, one of the parties of which is the Republic of Moldova, other provisions than containing in this law are established, provisions of international treaties are applied.

Article 3. Basic concepts

In this law the following concepts are used in value:

authorization - the process of assessment and the analysis causing from the technical and legal point of view implementation of activities in the field of donorship of blood, production of components and medicines of blood, and also use of those;

permission - the administrative legal act published by competent authority of public health care, setting conditions and/or parameters of implementation of activities in the field of donorship of blood, production of components and medicines of blood, and also use of those;

self-sufficiency - ensuring national need for blood and its components in the conditions of rational therapeutic use according to modern practice of transfusion therapy;

blood transfusion office - structure as a part of medical and sanitary organization, responsible for acceptance of components and medicines of blood from the centers and departments of blood transfusion and issue of those in divisions of organization;

the center of blood transfusion - structure or the body responsible for collection and blood test, production of components and medicines of blood irrespective of use of those;

committee on transfusiology - group of specialists as a part of medical and sanitary organization, responsible for realization in it of policy on blood transfusion, its components and biomedical supplies of blood;

blood components - the constituting blood (erythrocytes, leukocytes, platelets and plasma) which can be received from blood of the donor by various methods;

derivative blood - the therapeutic product received by conversion of components of blood;

distribution - supply of blood and its components to other centers and departments of blood transfusion or for industrial and pharmaceutical conversion; the concept "distribution" does not belong to supply of blood or its components from office of blood transfusion of medical and sanitary organization to department of the same organization for use in the therapeutic purposes;

voluntary donorship of blood or its components - delivery by person of blood or its components at own will, without earning for it reward neither in cash, nor in any other form which can be considered replacement the monetary reward;

the blood donor or its components - the physical person taking blood test or components of blood;

the permanent voluntary blood donor or its components - the person taking blood test at least four times a year or components of blood of 20 times a year for at least five years in a row and continuing these activities;

blood donorship - intake of blue blood at one physical person (donor) in the sterile and apirogenny device containing anticoagulant;

haemo safety - set of procedures for supervision of the undesirable incidents or serious side effects arising both at the donor, and at the recipient and also epidemiological surveillance for donors;

quality management - set of the approved actions performed for the purpose of ensuring quality control at all levels in blood transfusion institutions;

biomedical supply of blood - the product received from blood by industrial and pharmaceutical conversion for the therapeutic purposes;

diagnostic medicine of blood - the product received by conversion of blood or its components for the diagnostic purposes;

the recipient - person to whom blood and/or its components is transfused;

the legal representative of the recipient - person who can represent in the procedure provided by the law without power of attorney the interests of the recipient if he is minor or is protected by judicial measure of protection;

department of blood transfusion - the division of medical and sanitary organization responsible for collection, storage and distribution of blood and its components irrespective of use of those;

the quality system - organizational structure, the procedures, processes and resources necessary for quality management implementation;

blood - the blood which is taken away from the donor in the sterile and apirogenny device containing anticoagulant, processed for transfusion or for production of biomedical supplies;

blood transfusion - introduction taken away from the blood donor or its components to other persons in the therapeutic purposes;

autologichny blood transfusion - introduction of blood or its components only to the donor of those;

traceability - set of the measures allowing to trace and identify each stage of activities - from assumption of person to donorship before therapeutic use of blood and its components, to establish connection between the donor and recipients using single national system of identification;

validation - establishment of documentary and objective evidences of the fact that the specific requirements relating to use of blood, its components and medicines of blood are executed in full.

Article 4. Principles of donorship and blood transfusion and its components

Donorship and blood transfusion and its components are performed on the basis of the following principles:

a) blood recognitions by national resource;

b) freedoms of donorship: any person cannot be forced in any form to donorship of blood and its components;

c) guaranteeing health protection of donors and recipients;

d) voluntary and non-paid donorship of blood and its components;

e) quality assurances of blood and its components;

f) self-sufficiency of blood and its components;

g) rational use of blood and its components;

h) ensuring anonymity of the donor and recipient.

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