Preparation of documents for obtaining a medical practice license: what do you need to know?

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License for medical practice in Ukraine
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Starting a medical business, whether a dental practice or a private medical office, invariably requires a license.

Those who have encountered the process of obtaining permits understand its complexity and the specific knowledge and skills it demands. Not to mention the inevitable expenditure of personal time and resources.

Today, let's delve into the principal aspects of the medical practice licensing process. If you're looking to understand not how to do it, but who can manage this responsibility for you – we are here to help. With our assistance in obtaining your medical license:

  • We commit to delivering results. Every task is manageable for us, whether it's handling MRI, amendments for state hospitals employing over 300 medical professionals, telemedicine, etc.
  • Comprehensive services under one roof: metrology, accreditation, license modifications, the Electronic Healthcare System (EHS), the National Health Service of Ukraine (NHSU), handling the 309th resolution, and even strategizing your medical business. We operate across all regions of Ukraine.
  • Dependability. One in every two clients returns to us for additional services or to expand their business, because we ensure safety, integrity, and results.
  • Over 15 years of legal expertise. In just the past three years, we've secured over 80 licenses. Working with us is engaging because we have all the answers and know exactly what to do, even if your documentation isn't in perfect shape initially.

Our service: Medical License

The Document Preparation Process for Obtaining a License

Before submitting your application to the licensing commission, it's important to choose a suitable and safe workspace. Currently, obtaining a sanitary-epidemiological survey report is not a legal requirement for a medical license, as it was previously. However, you can opt to acquire it. Possessing this SES (Sanitary and Epidemiological Service) Certificate ensures the safety of your clinic for patients' health and life, and it will be an excellent addition to confirming your professionalism and dedication.

After selecting your ideal location and deciding on the SES Certificate, you can start compiling the necessary documents for the Ministry of Health.

Related article: Obtaining a SES Certificate in Ukraine: Challenging Cases from Our Experience

To obtain a medical license, you need to submit three key documents:

  • An application for the license;
  • Information regarding the state of the material-technical base and the availability of staff;
  • A detailed description.

To mitigate any practical issues and errors, it is advisable to use standardized templates for these documents. Samples of these documents are available on the website of the Verkhovna Rada of Ukraine's web portal.

Application for a License and Descriptions of Documents

These documents are quite simple to fill out, hence their discussion is combined here.

In the application, it's critical to accurately fill in your enterprise's details. Common issues include using an abbreviated or incorrect name for the enterprise, incorrect codes, and addresses, or forgetting the applicant's signature. Ensure every section of the Application is meticulously and thoroughly completed.

The Description is essentially a structured list of documents to be submitted along with the application. While filling out this document is generally straightforward, ensure that it only includes the documents being submitted to the Ministry of Health.

Statement on the State of Material-Technical Base and Staff Availability with Educational and Qualification Levels

This document is the most complex to complete. It's where errors are most frequently made.

We will tell you what to pay attention to in each section, and how to fill it out.

Section 1. Information on the medical staff's specialties for medical practice activities. In this section, it's essential to specify the specialties that align with your activities, such as pediatrics, dentistry, or general family medicine, among others. A common issue arises when specialties are listed here that do not require licensing according to the Licensing Conditions.

Related article: Obtaining a Medical License for Ophthalmologists: Most Common Questions from Our Practice

Section 2. Types of medical services provided. This section requires specifying the medical assistance types. The methods employed by the healthcare institution depend on the specialty. These methods must align with the main professional tasks and responsibilities of the specialists, considering the institution's activity profile and the level of medical care provided.

Section 3. Signage at the entrance of medical practice locations. This involves stating the name of the legal entity and the type of institution. Sometimes the EDRPOU code and address are also mentioned, though it's not mandatory. The type of healthcare institution depends on its functional purpose (what it's opened for), the type of medical specialties, the category of patients, and the type of medical assistance.

Section 4. Founding documents and structure of the healthcare institution. This section includes details of the document that established the healthcare institution. This could be a Charter or Regulations under which the healthcare institution was created.

Section 5. Details of the document authorizing the use of the premises. The premises can be owned or rented. Here, you should indicate the Extract from the State Register of Real Property Rights or the Lease Agreement for the premises, i.e., the basis on which you occupy the premises. However, there are nuances!

  • Agreements made before the business entity's registration to evade taxes can lead to license refusal.
  • Lease agreements lasting over 3 years for non-residential premises are subject to notarization and registration.

Related article: Space and Structure Requirements for Physicians' Offices

Section 6. Information on the material-technical base at medical practice locations. This section, known for its complexity, requires meticulous detailing.

The most common mistakes include:

  • Failing to differentiate rooms based on their functional purpose.
  • Listing rooms for specialties that were not declared in the application or in Section 1, which often leads to a rejection.
  • Not including all the necessary spaces for the declared specialties. For instance, for surgical interventions, just having an operating room is not enough; a post-operative room is also essential.

Please note! It should include the name of each room, the specific medical specialty it caters to, the operating hours of the medical staff, the dimensions of each room, and the required equipment.

  • The most frequent errors are found in the fourth part of this section. It's vital to list all medical equipment and devices necessary for the proposed scope of medical services.
  • You should enumerate the equipment used in each room, including its condition, year of manufacture, manufacturer, and model. It's prudent to list every item of equipment mentioned in the equipment inventory to prevent any formal reasons for denial.

Section 7 deals with the metrological verification of equipment.

Typical errors here involve incomplete details in the metrological verification documents and omitting certain measuring equipment that requires verification.

Sections 8 and 9 are about the compliance with educational and qualification requirements of the medical staff, including doctors, junior medical (or pharmaceutical) staff, rehabilitation specialists, and other professionals employed at the institution.

Please note!  There should be no vacant positions.

Related article: The Process of Obtaining Medical Licenses for Family Physicians, Therapists, and Pediatricians Amidst Medical Reforms  

Section 10. Work experience of the healthcare institution's head and individual entrepreneur as recorded in the employment record book for the last 5 years or existing license details.

In this section, you'll need to fill in data from the labor book, detailing information about employment (specific workplaces) and the credentials of the documents based on which employment or termination was executed. It's important to note that an employee of a budgetary institution in a managerial role cannot hold a concurrent position.

Related article: CEO and CMO Roles in Healthcare Institutions

This completes the preparation of the Statement. Don't forget other essential aspects like page numbering, binding, authentication with the signature of an authorized person, and the date the Statement was compiled.

The Medical License Acquisition Process

In the past, after submitting all documents, the licensing body would make a decision within 10 working days. Typically, we would receive a result within two weeks, which the Ministry of Health would then publish on its website.

Unfortunately, obtaining a license quickly is more challenging today due to the war conditions in our homeland. With martial law in place, the Ministry of Health no longer specifies or guarantees any fixed timelines for committee meetings or license issuance decisions.

Once a positive decision on license issuance is received, a fee equal to one minimum living wage at the time of license receipt must be paid.

This fee should be paid within 10 working days from the date the license issuance decision is announced. After payment, the license can be collected in the format stated in the application.

Our service: Medical License

For any inquiries regarding the medical license acquisition process, feel free to consult with our company's specialists.

Publication date: 31/07/2019

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