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Obtained medical license for a diagnostics center in Ukraine

Licensing of diagnostics centers in Ukraine

One of the first Clients, that contacted our company for legal assistance in obtaining a Medical License after the licensing regulations were amended in spring of 2016, was the diagnostics center from the Ivano-Frankivsk region. This health care facility intended to provide health care services in the field of ultrasound diagnostics.

It’s worth noting that when the Client contacted our law firm, the old version of the licensing regulations were still in force and all preliminary consultations were carried out in accordance with their provisions. However, due to the fact that the preparation of the diagnostic center premises and sanitary and epidemiological expertise took much time, the submission of documents to the licensing authority, the Ministry of Health of Ukraine, was delayed until the approval of the new licensing regulations. Such a turn of events resulted in a number of consequences:

1. The format of statements that shall be attached to the application for a Medical Licence was changed (it was no longer required to submit the statements on the regulations and reporting forms, and the statement on the technical and material base and the staff qualification was combined into a single document);

2. The requirement to obtain and submit a conclusion of the Sanitary and Epidemiological Service of Ukraine was abolished (instead, it is required to obtain a Sanitary and Epidemiological Certificate for the premises of the diagnostics centre).

The first point was not particularly critical, since the new combined statement contained the same data that had already been filled in by our lawyers in the old statements, and therefore it wasn’t difficult to amend the document.

Though, we were faced with some difficulties related to amending the document confirming the sanitary compliance of the premises. The fact is that after the examination of the premises, our Client was provided with a conclusion of the Sanitary and Epidemiological Service of Ukraine, as required by the old licensing regulations. But pursuant to the new regulations, it was required to obtain the Sanitary and Epidemiological Examination Certificate. As the analysis of the regulatory framework has shown, such a Certificate should have been executed by the Sanitary and Epidemiological Service before the issuance of the conclusion, but according to the practice of that time they didn’t hand over this document. That is why, when our Client requested the Sanitary and Epidemiological Service to issue the Certificate, they refused him, claiming that the Certificate is an internal document. In response to such actions of the state authority, our lawyers had to build a clear and reasoned legal position, which helped to achieve positive results, when negotiating with the Sanitary and Epidemiological Service, and allowed the Client to obtain the necessary document without additional procedures.

Once the Certificate was obtained, our lawyers prepared a package of documents and submitted it to the licensing authority under the power of attorney. A positive decision to issue the license was made at the nearest meeting of the licensing commission. Right after that we paid the official license fee and obtained the license form, which was promptly delivered to the Client by courier service.

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