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Prikhodko&Partners
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Licensing of business activities Cord blood bank license

Tetiana Ryzhova

Head of Medical Law Practice

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ryzhova@prikhodko.com.ua

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Specializes in medical, corporate, and migration law. Has extensive experience working with medical and pharmaceutical businesses, particularly in licensing, circulation of medicines, and comprehensive legal support of healthcare institutions, including corporate, tax, and employment matters, as well as market entry projects of foreign companies into Ukraine.

Cord blood bank license

Special regulatory legal acts of the Ministry of Health and Licensing Conditions approved by Resolution of the Cabinet of Ministers No. 286 establish requirements for the activities of cord blood banks, as well as the procedure for their licensing. Today, a license for such activities must be obtained before starting activities related to:

cryopreservation of cord blood;
storage of cord blood;
use of the specified material for transplantation and for medical purposes.

Obtaining a license involves passing a mandatory procedure for assessing the applicant’s compliance with the requirements regarding its registration, premises, personnel, etc. In the article, we will examine these aspects in more detail.

Who can obtain a license for the activities of cord blood banks?

Legal entities or individual entrepreneurs who:

firstly, have registered KVED 86.90 or 86.21 (if the activity is combined with licensed medical practice);
secondly, have developed and implemented standard operating procedures for the transportation of biological material and the implementation of the activities of the umbilical cord blood bank for its implementation;
thirdly, demonstrate the ability to comply with state sanitary norms and rules for the organization of laboratory work, medical waste management in accordance with the rules of the Ministry of Health.

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Requirements for the material and technical base

To carry out their activities, cord blood banks must have appropriate means, including:

owned or leased premises. Such premises include a biotechnology laboratory, cryo-storage and auxiliary units (if necessary). The activities of cord blood banks must be carried out in non-residential premises, with access for citizens with limited mobility;
instruments, equipment and measuring instruments. This includes equipment for the procurement, processing, cryopreservation, storage and testing of biological material;
products that meet the quality and safety standards of the Ministry of Health. There must also be a detailed description of cord blood products and preparations, including their characteristics, processing methods, and purpose.

It will also be useful: License for veterinary practice

Personnel requirements

The current Licensing Conditions, approved by Resolution of the Cabinet of Ministers of Ukraine No. 286, also establish clear qualification requirements for various categories of personnel, in particular:

the bank manager. He must have a full state higher education in one of the prescribed specialties (“Medical Care”, “Medical and Preventive Care”, “Biochemistry”, etc.) and a certificate of completion of training in the management of a healthcare facility;
medical workers. This category includes doctors and junior medical workers, each of whom must confirm with a diploma or certificate of receipt of a full (for the first category) or basic (for the second category) higher education in the specialties provided, including for the head of the cord blood bank.

Important: staff must undergo regular training and advanced training in accordance with the requirements of the legislation. You can find out more by receiving professional advice from one of our lawyers in the field of licensing medical institutions.

How to obtain a license for the activities of cord blood banks?

Who issues the license?

The authority authorized to issue the license is the Ministry of Health of Ukraine (MOH). Submission of documents is carried out directly to the state body by:

personal application to the office with a package of documents;
sending documentation by mail (registered letter with a description of the attachment) to the MOH;
submitting documents in electronic form using the KEP through the “Diya” portal.

Price of legal assistance

How much does it cost to obtain a license for the operation of cord blood banks in 2025?

A one-time fee of one subsistence minimum, equal to 3,028 hryvnias as of April of this year, is charged for issuing a license.

What documents are required?

To obtain a permit to carry out activities in the field of cord blood sales, an entrepreneur must submit the following set of documents:

a statement of the established form;
information on the material and technical base (premises, equipment and other resources);
information on personnel indicating their educational and qualification level;
attached documents (copies of the manager’s passport, an extract from the Unified State Register of Registration of a legal entity or individual entrepreneur, certificates of ownership, lease agreements, certificates of verification of equipment);
a copy of the receipt for payment of the license (state duty);
a description of the submitted documents.

The lawyers of “Prikhodko & Partners” are ready to provide professional support in preparing the necessary documentation and simplify the entire process. The cost of such support can be found out directly during an introductory consultation with our qualified lawyer.

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