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Introduction of amendments to the medical practice license in Ukraine: our experience

Obtainment of a Medical License is a difficult and long-awaited result both for private practitioners and healthcare facilities. At the same time, not all of them know that the approval of their package of documents by the Ministry of Health of Ukraine during licensing is not final. In case of some changes, it will be necessary to submit documents and information again.

Failure to notify the licensing authority of changes related to your activities may result in fines, revocation of the license, and in particularly complex cases of medical harm, this may even result in criminal liability.

In this publication, we will elaborate on the changes and the form they shall be reported to the licensing authority.

General requirements for introducing changes to the Medical License

As a general rule, the licensing authority shall be notified of all changes in the data specified in the documents submitted for licensing. In practice, this means that even minor changes such as a change of equipment (purchase, replacement or removal) must be approved. This is accentuated by the tight deadlines. The licensing authority shall be notified of any changes within one month.

In order to make changes in the Medical License, you shall provide the licensing authority with a new version of the statements and a cover letter, indicating the modified items. 

Related article and video: Preparing Documents For Obtaining A Medical License: What Do You Need To Know?

In contrast to obtaining a license, amendments are considered longer (in practice, it takes about a month, compared to 2 weeks), and do not require any official fees.

Below we will consider the specific aspects of this procedure, which most often cause difficulties for our Clients: both for health care facilities and private practitioners. 

Staff changes in a health care facility

Staff-related changes shall be introduced to the Medical License in case of change of doctors and paramedics only. This means that such positions as administrators, cleaners, nursing assistants, etc., are not required to be approved by the Ministry of Health of Ukraine.

The staff changes include:

  • Change of main job to part-time job or vice versa;
  • Change of position: for example, when an ophthalmologist obtains an additional certificate in paediatric ophthalmology and starts the relevant practice;
  • Updating qualification documents: for example, obtaining a qualification category or a new medical specialist certificate;
  • Recruitment of new health workers, even within the existing specialties, as well as termination of employment relationships with doctors and paramedics.

Related article: Can A Person With A Medical Degree Work As A Junior Specialist?

A special case that requires to notify the licensing authority of changes is failure to conclude an employment agreement with employees specified when applying for a license within one month upon the approval of the Ministry of Health of Ukraine. In this case it is necessary to:

  • Approve new specialists for the required specialties;
  • Submit an application for termination/suspension of activities under the corresponding specialty(s).

Business address-related changes

  • You move to another address. In practice, if you move to another address, this means that you change the material and technical base. In this case (provided that no personnel is changed), it is necessary to properly get a new premise for use. For example, you need to rent or purchase it. You shall also obtain the Sanitary and Epidemiological Certificate.

The notice of changes shall clearly specify the future business address and the address to be removed from your license.

  • You enlarge your network. In this case, it is a question of saving the original address and adding new ones.

In addition to the actions already mentioned in the previous paragraph, it is necessary to specify a new address with personnel and devices, medical products, etc.

In the notice, you shall emphasise the registration of an additional address to avoid any misinterpretation of the documents by the specialists of the Ministry of Health and replacement of one address by another.

  • You close your office or health care facility. If you want to close the address, it will be sufficient to submit an application. If this is your only address, you can submit:
- An application for temporary suspension of activities, e.g. due to lack of necessary staff;
- An application for revocation of a license, if you terminate your activity. 

Changing the form of license documentation

A specific form of making changes to the Medical License is the submission of a new set of documents in the event of a change in the form of statements (documents that are submitted with the application to the Ministry of Health of Ukraine). In theory, this means that you need to resubmit old information in a new form.

The law, which regulates the sphere of licensing, stipulates that in this case, the term for submission of new documents is established by the relevant License Terms. The current version of the License Terms does not set forth such a time limit, and therefore no notices are required to be sent to the Ministry of Health so far. This fact is also confirmed by official statements from this authority.

Note! If you have obtained a perpetual license under the old License Terms and you need to make any changes related to a particular business address, you will need to revise the entire document.

Related article: Legal Risk Management In Healthcare 

Responsibility for failure to notify

Failure to notify the licensing authority of changes in the Medical License will most likely result in its revocation. Although the licensees usually have some time to bring their activity into compliance with the law after the first inspection, in practice they are usually short of time to complete all of the corrective actions required. That is why the second inspection may be the last one.

Related article: Why Is It So Important To Apply In Advance For Legal Assistance During The License Inspection?

In addition, the Code of Ukraine on Administrative Offences provides for imposing a fine in the amount of 17,000 to 34,000 UAH for carrying out economic activity contrary to the License Terms. And failure to notify the licensing authority of any changes in the Medical License can be interpreted as such.

Last, but not least, is criminal liability. For example, failure to notify the licensing authority of a new employee, whose activity caused serious health harm to a patient, may negatively affect the results of the court proceedings and identification of persons responsible for such harm.

Conclusion

Changes to the Medical License are not always obvious, but they are an important element of the activities of a physician entrepreneur or a healthcare facility.

Changes to the Medical License shall be made in accordance with a specific procedure that differs depending on the points of statements that are no longer relevant and need to be updated.

The key mainspring to follow the requirements of the licensing legislation in this area is responsibility, which may take the form of a financial penalty or a criminal sanction.

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