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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of March 2, 2016 No. 286

About approval of Licensed conditions of implementation of economic activity of banks of umbilical blood, other fabrics and cells of the person according to the list approved by the Ministry of Health

According to Item and paragraph one of part two of article 9 of the Law of Ukraine "About licensing of types of economic activity" the Cabinet of Ministers of Ukraine decides 16 parts one of Article 7:

Approve Licensed conditions of implementation of economic activity of banks of umbilical blood, other fabrics and cells of the person according to the list approved by the Ministry of Health which are applied.

Prime Minister of Ukraine

A. Yatsenyuk

Approved by the Resolution of the Cabinet of Ministers of Ukraine of March 2, 2016 No. 286

Licensed conditions of implementation of economic activity of banks of umbilical blood, other fabrics and cells of the person according to the list approved by the Ministry of Health

General part

1. These Licensed conditions determine the exhaustive list of the requirements obligatory for accomplishment by the licensee, and also the exhaustive list of the documents enclosed to the application for receipt of the license for implementation of economic activity of banks of umbilical blood, other fabrics and cells of the person (further - the license) according to the list approved by the Ministry of Health (further - activities of banks of umbilical blood).

The licensee shall fulfill requirements of these Licensed conditions, and the license applicant - it to correspond.

2. Action of these Licensed conditions extends to the subjects of managing registered in the procedure established by the legislation as legal entities, irrespective of their form of business and pattern of ownership performing activities of banks of umbilical blood and on the physical persons entrepreneurs performing such activities.

3. Terms in these Licensed conditions are used in such value:

autologichny use - cages or fabrics which are taken from certain person and are applied to it;

the bank of umbilical blood, other fabrics and cells of the person (further - bank) - subject of managing or structural division of the company which obtained the corresponding license and independently or by means of the third parties performs the activities;

biological safety - system of the organizational, medicobiological and technical actions and funds allocated for protection of the personnel working, the populations and habitats of the person from impact of pathogenic biological objects;

biological material - fabrics, cages, the biological liquids, secrets and waste products, physiological allocations, dabs, scrapes, washouts, biopsiyny material received from the person and also material of embrio-fetalny origin;

the biotechnology laboratory - laboratory which is the integral structural division of the bank performing conversion (processing) of biological material, marking (coding) and in case of need holds testing (checks) of products and/or medicines of umbilical blood, other fabrics and cells of the person;

heavy adverse reaction - unexpected reaction, including infectious disease, at the donor or the receiver, connected with procurement or human use of fabrics and cages which is deadly, life-threatening, causes disability, incapacity or which entailed or continued hospitalization or incidence;

interaction with the third parties - transfer of results of accomplishment of stage of engineering procedure from bank to other organization which bears responsibility for results of accomplishment of this stage of engineering procedure. In case of interaction with the third parties transfer is allowed:

results of testing (check) of blue blood of the donor of umbilical blood, other fabrics and cells of the person, biological material, products and/or medicines of umbilical blood, other fabrics and cells of the person in certified/accredited in the procedure for laboratory established by the legislation;

for storage of biological material in case of reorganization or the termination of activities of bank of umbilical blood to organization which has the corresponding license;

traceability - opportunity to trace and identify cages or fabrics at all stages of the address, in particular donorship, procurements, conversion (processing), testing (check), conservation, storage, provision (realization) and/or clinical application, their utilization, with opportunity to identify the donor (except cases when it is forbidden or it is impossible) and the relevant organizations which take away or receive, process and store cages or tissues of the person. Traceability also gives the chance to identify all essential data on the products and materials contacting to cages or fabrics;

activities of bank of umbilical blood - economic activity on conversion (processing), marking (coding), conservation, testing (check), storage, provision (realization) and/or clinical application of products and/or medicines of umbilical blood, other fabrics and cells of the person;

procurement - the procedure of withdrawal by means of which biological material becomes available to further stage of engineering procedure. Responsibility for ensuring procurement of biological material is conferred on bank;

storage - content of biological material, products and/or medicines of umbilical blood, other fabrics and cells of the person under the corresponding controlled conditions until their clinical application and/or provision (realization) or utilization;

quarantine - the status of the taken-away fabrics or cages separated physically or other efficient means at stage before decision about their acceptance or utilization;

cages - separate/discrete cages, or the cellular cultures of in vitro which are not connected among themselves in any fabric (except for reproductive cages);

conservation - use of chemical agents and/or changes of physical factors of the environment in production process for the purpose of prevention or delay of their biological or physical destruction;

provision (realization) - transfer on a grant basis or sale to the third parties of products and/or medicines of umbilical blood, other fabrics and cells of the person;

product and/or medicine of umbilical blood, other fabrics and cells of the person the product and/or medicine consisting from raw or in different degree of the processed (manipulated) cages/fabrics and excipients or from the raw or manipulated cages/fabrics and excipients in combination with pharmacological substances and/or products of medical appointment. The fabrics and cages used as autologichny transplants within one surgical procedure also do not give in to conservation and storage, are not products and/or medicines of umbilical blood, other fabrics and cells of the person;

conversion (processing) - production of products and/or medicines of umbilical blood, other fabrics and cells of the person;

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