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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of February 24, 2021 No. 158

Some questions of implementation of the Law of Ukraine "About application of transplantation of anatomic materials to the person" concerning bioimplants, ksenoimplantat, medicobiological requirements to animals, conditions of their content, procedure for withdrawal at animal anatomic materials for production of ksenoimplantat

According to parts three and the fourth article 18 of the Law of Ukraine "About application of transplantation of anatomic materials to the person" the Cabinet of Ministers of Ukraine decides:

1. Approve enclosed:

Procedure for production, quality control and address of bioimplants;

Procedure for production, quality control and address of ksenoimplantat;

medicobiological requirements to animals, conditions of their content, procedure for withdrawal at animal anatomic materials for production of ksenoimplantat.

2. Determine that bioimplants which underwent state registration in product quality of medical appointment are resolved for application in the territory of Ukraine before entry into force of this resolution.

3. Bring in the list of types of products concerning which bodies of the state market supervision exercise the state market supervision approved by the resolution of the Cabinet of Ministers of Ukraine of December 28, 2016 No. 1069 (The Official Bulletin of Ukraine, 2017, No. 50, the Art. 1550), change which is applied.

4. This resolution becomes effective in two months from the date of its publication.

Prime Minister of Ukraine

D. Shmygal

Approved by the Resolution of the Cabinet of Ministers of Ukraine of February 24, 2021 , No. 158

Procedure for production, quality control and address of bioimplants

General part

1. This Procedure determines the mechanism of production, quality control and address of bioimplants.

2. This Procedure is developed taking into account the Directive 2004/23/EU of the European Parliament and Council of March 31, 2004 about establishment of the quality standards and safety for donorship, procurement, check, processing, preservation, storage and distribution of human fabrics and cages, the Directive of the Commission 2006/17/EC of February 8, 2007 which establishes rules of implementation of the Directive 2004/23/EU of the European Parliament and Council concerning certain technical requirements concerning donorship, purchases and testing of fabrics and cages of human origin, the Directive of the Commission 2006/86/EC of October 24, 2006 which implements the Directive 2004/23/EU of the European Parliament and Council concerning requirements of tracking, the message on serious collateral reactions and events and certain technical requirements to coding, processing, storage, accumulating and distribution of fabrics and cages of human origin, Regulations (EU) 2017/745 European Parliament and Council of the April 5, 2017 about medical products making changes to Directives 2001/83/EC, the resolution (EU) No. 178/2002 and the resolution (EU) No. 1223/2009.

3. The terms used in this Procedure have the following value:

skin allotransplantata - the products of medical appointment made of anatomic material of the person in the form of skin;

production of bioimplants - the transactions consisting of processing and conservation of the anatomic materials of the person intended for production of bioimplants, packaging of ready bioimplant owing to which the bioimplant becomes available to application to destination;

the producer - the legal entity (the resident or the nonresident of Ukraine) who makes bioimplants or charges their production and distribution of bioimplants under the name or trademark;

organization which provides anatomic materials - healthcare institution, bureau of forensic medical examination or other subject of managing which is engaged in withdrawal of anatomic materials of the person for further production of bioimplants;

application to destination - use of bioimplants according to the purposes specified by the producer in its marking and/or the instruction for application;

storage - content of the anatomic materials of the person intended for production of bioimplants in the corresponding controlled conditions until their direction to the producer of bioimplants;

identification of anatomic materials - assignment and provides to the anatomic materials intended for production of bioimplants, unique distinctive code which is used for their marking opportunity their tracking from the withdrawal moment until application to destination of bioimplant;

identification of the donor - provision to the donor of unique number for possibility of tracking of its anatomic materials intended for production of bioimplants;

identification of the died person - identification of the died person on its passport data;

quarantine - the status of the selected anatomic materials of the person intended for production of bioimplants before decision about their acceptance for production of bioimplants or variation;

conservation - use of chemicals and/or physical factors of impact in the course of production of bioimplants for the purpose of prevention or delay of their biological or physical destruction;

processing - all transactions with the anatomic materials of the person intended for production of bioimplants which are connected with preparation, manipulations of impact of chemicals and physical factors and change of their structure;

assessment of conformity of bioimplants - check of compliance of bioimplants to quality requirements and safety of testing, withdrawal, storage and transportation of the anatomic materials of the person intended for production of bioimplants, process of their production and the producer concerning its compliance to requirements of this Procedure;

traceability - opportunity to trace and identify the anatomic materials of the person intended for production of bioimplants, and the bioimplants made of them from the withdrawal moment until their application to destination;

serious unfavorable event (case) - any unfavorable event connected with withdrawal, processing, storage and transportation of the anatomic materials of the person intended for production of bioimplants which can lead to transfer of infectious diseases, death or threat for life, disability or incapacity of patients or which can entail or continue their hospitalization or diseases;

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