Blood bank licensing

Procedure for obtaining a license

In order to open a cord blood bank, first of all, it is necessary to register either an individual entrepreneur or a legal entity, while the easiest and most convenient way is to register a limited liability company. It is best to register a legal entity even before signing the lease agreement for the premises. To do this, you should contact the Center for Administrative Services Provision, or the state registration department with a relevant application and the Articles of association of your legal entity. Next, you need to obtain a cord blood bank license.

When obtaining a license, you must submit the following documents:

  1. Application for a license.
  2. Information on the state of the material and technical base of a business entity;
  3. Information on the availability of personnel, indicating their educational and qualification levels required for the operation of the bank of umbilical cord blood, other tissues and human cells.
  4. The copy of the passport of the head of the license recipient (or the authorized person) with the mark of the tax service body about the notice on the refusal, due to their religious beliefs, to accept the registration number of a taxpayer’s accounting card (is submitted only by individual entrepreneurs who, due to their religious beliefs, refuse to accept the registration number of a taxpayer’s accounting card and notified the relevant body of the state tax service).
  5. List of documents.

It should also be remembered that the license is issued subject to all the conditions specified in the Order of the Cabinet of Ministers of Ukraine of 02.03.2016 No. 286 “On approval of the Licensing conditions for the implementation of economic activities of banks of umbilical cord blood, other human tissues and cells according to the list approved by the Ministry of Public Health.”

Organizational conditions

According to the above Order of the Cabinet of Ministers of Ukraine No. 286, in order to obtain a license, it is necessary to ensure that the following conditions are met:

  1. it is necessary to ensure the availability of premises owned, leased or used according to another right of use, ensuring the course of the bank technological processes, in particular the biotechnological laboratory, cryostorage, auxiliary structural units, in accordance with the technological requirements provided for in these Licensing Conditions;
  2. it is also impossible to carry out activities without instruments, equipment and verified measuring instruments that ensure the course of the technological process, in accordance with the technological requirements provided for in the Licensing Conditions;
  3. ensure the collection of data on the institution structure and the personnel;
  4. carry out the process for describing products and / or preparations of umbilical cord blood, other human tissues and cells produced by the licensee.

Remember that you will also have to approve the structure, the staff schedule of the bank, the standard operating procedures, which indicate the order: of transportation of biological material (indicating the means of transportation, minimum and maximum temperatures, transportation time), implementation of all processes of the cord blood bank that allow ensure compliance with the Licensing Conditions.

It is also necessary to store the documents confirming the performance of works related to the storage, processing of biological material, labeling (coding), testing (verification) of products and / or preparations of umbilical cord blood, other human tissues and cells.

Technological requirements

In addition to the provided organizational conditions, it is also necessary to ensure the following technological requirements of the legislation on operation of cord blood banks, for example:

  • Cord blood banks operate in non-residential premises, isolated from other premises.
  • All stages of work with biological material are carried out in the premises after the implementation of measures aimed at minimizing the risk of bacterial contamination (or contamination of another kind) of tissues and cells in compliance with the sanitary and epidemiological regime.
  • The premise should be equipped with germicidal lamps.
  • The cryostorage premise with the volume of liquid nitrogen over 2000 liters is equipped with supply and exhaust ventilation with mechanical induction or mixed natural exhaust ventilation with a mechanical supply, which ensures the oxygen content in the air of the cryostorage premises at a level of at least 19 percent, as well as a gas analyzer, which is blocked fromwarning system (light and sound).
  • In the cryostorage premises, a separate place is supposed to store overalls, special footwear and other personal protective equipment, which are provided for personnel working with liquid nitrogen.
  • In the activities of the cord blood bank, technically sound devices, equipment and measuring instruments are used, for which there are technical passports, operating instructions.
  • Measuring instruments are subject to periodic verification and verification after repair.
  • The devices used must comply with the safety and electromagnetic compatibility standards.
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