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Got medical practice license for lab of sole trader in Ukraine

Licensing of laboratories in Ukraine

In June 2015, our law firm successfully completed a project for getting a license for the clinical diagnostic laboratory of a sole trader from Kherson region.

The client decided to order services for obtaining a license for medical practice not only after several denials by the Licensing Commission of the Ministry of Health. Given the fact that the premises were rented, and employment contracts were concluded  with the junior medical staff, each denial delayed the launch of the laboratory and caused financial losses. Thus, the lawyers of the medical law practice were faced with the challenge of correcting the mistakes that had been made during the independent preparation of documents and getting a license for medical practice as quickly as possible.

So, the key remarks of the Ministry of Health, which are communicated to the applicants in the form of an official letter, which is to be sent to the legal address of the company or to the place of registration of a sole trade, were regarding the statement No. 1 (on the material and technical base) and No. 2 (on regulatory documents and reporting forms).

Despite the fact that the Сlient was able to basically correctly fill out the material base statements independently, they made mistakes in indicating the type of medical care in clause 2, and also incorrectly indicated the names of rooms and medical occupations, for which the practice is to be carried out. The fact is that, despite its seeming obviousness, especially to doctors who have worked in the field of medicine for many years, the above points are clearly regulated by laws and regulations and sometimes the “letter” of the law differs from the understanding of the applicant, and therefore even the smallest discrepancies can cause denial.

There were other remarks on the above statement, which not only called for the correction of technical errors, but also getting additional documents. So, the list of the declared equipment contained a number of measuring instruments subject to metrological verification, but our client did not have the relevant supporting documents. Our lawyers provided advice on the procedure and bodies for the verification and, within the shortest possible time, we had all the documents to finalize the package of documents for submission.

It should be noted that in parallel with the metrological verification, our lawyers corrected the statement on the norms and regulations, considering  the remarks of the Ministry of Health, and also provided samples of the necessary reporting forms that would be useful to the Client in the future.

It was decided that our lawyers would submit the statements to the Ministry of Health via a power of attorney.

We got a positive response at the very first meeting of the Licensing Committee.

At the final stage, we advised the client on making the official payment for the medical license, filed the payment receits with the licensing authority and monitored the status of the license form completion.

Learn more about our services and experience in obtaining medical practice licenses.


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