ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of February 5, 2025 No. 56

About exchange of the human bodies intended for transplantation between the Republic of Moldova and other states, import and export of fabrics and cells of the person

The government DECIDES:

1. Approve:

1.1. Regulations on exchange of the human bodies intended for transplantation between the Republic of Moldova and other states, according to appendix No. 1.

1.2. Regulations on import and export of the fabrics and cells of the person intended for therapeutic use at the person according to appendix No. 2.

2. To the Ministry of Health to approve regulations on implementation of the Regulations on exchange of the human bodies intended for transplantation between the Republic of Moldova and other states and Regulations on import and export of the fabrics and cells of the person intended for therapeutic use at the person.

3. To provide to transplantation agency methodological and advisory support to the suppliers of medical services having permissions for accomplishment of conditions of the provisions specified in Item 1.

4. To the suppliers of medical services having permissions to provide accomplishment of conditions of the provisions specified in Item 1.

5. To impose control over the implementation of this resolution on the Ministry of Health.

6. Financing of activities for exchange of the human bodies intended for transplantation between the Republic of Moldova and other states, to import and export of the fabrics and cells of the person intended for therapeutic use at the person will be performed for the account and within the means which are annually approved in the government budget, funds of compulsory medical insurance and also from other sources, according to the legislation.

7. This resolution becomes effective after one month from the date of publication in the Official monitor of the Republic of Moldova, except for Item 3 of the Regulations on exchange of the human bodies intended for transplantation between the Republic of Moldova and other states which will become effective at the time of the entry of the Republic of Moldova into the European Union.

Appendix №1

to the Order of the Government of the Republic of Moldova of February 5, 2025 No. 56

Regulations on exchange of the human bodies intended for transplantation between the Republic of Moldova and other states

This Provision shifts:

- Items (b), (c), (g), (n), (o), (s) of Article 3, part (4) Articles 9, part (2) Articles 18, Article 20 and 21, and also Appendix (Part of A "Minimum Data" and the Part of B "Additional Data") to the Directive 2010/53/EU of the European parliament and Council of July 7, 2010 about the quality standards and safety for the human bodies intended for transplantation (CELEX: 32010L0053), published in the Official magazine of the European Union by L 207 of August 6, 2010;

- The executive directive 2012/25/EU of the Commission of October 9, 2012 about establishment of information procedures of exchange between state members the human bodies intended for transplantation (CELEX: 32012L0025), published in the Official magazine of the European Union by L 275 of October 10, 2012.

Chapter I. General provisions

1. The regulations on exchange of the human bodies intended for transplantation between the Republic of Moldova and other states (further - the Provision) regulate:

1.1. exchange of the human bodies intended for transplantation between the Republic of Moldova and other states;

1.2. information procedures, in case of implementation of exchange of the human bodies intended for transplantation between the Republic of Moldova and other states, for the purpose of observance of quality requirements and the safety equivalent to requirements of the European Union (EU).

2. For the purposes of this provision the following concepts are applied:

2.1. the State of origin - the state in which the human body for transplantation is withdrawn;

2.2. the state of appointment - the state to which the human body for transplantation goes;

2.3. national identification number of the donor/receiver - the identification code (IST Code) assigned for the donor or the receiver, automatically generated by the Information system "Transplant";

2.4. the specification of body - the anatomic description of human body which includes the following information:

2.4.1. type of human body (for example, heart, liver);

2.4.2. provision of body in body of the person (at the left or on the right);

2.4.3. whether it is the whole body or part of body, with indication of share or segment of relevant organ, proceeding from circumstances;

2.5. the delegated body - competent authority of the Republic of Moldova or other state, or the international organization for exchange of bodies which/which delegated powers according to the conclusion of agreements with the international organizations for exchange of human bodies;

2.6. competent authority - any authority, organism, the organization or organization responsible for coordination, supervision, issue of permission and inspection of activities in the field of transplantation, and also for implementation of regulations in the field of transplantation. Competent authority in the field of transplantation in the Republic of Moldova is the transplantation Agency;

2.7. the European organization for exchange of bodies - the non-profit, state or private organization which is engaged in national and international exchange of human bodies most of which of member countries is EU member states;

2.8. traceability of bodies - capability to determine location and to identify human body at any stage of chain, from donorship before transplantation or destruction, including opportunity:

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