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

A health business, opening of a dental or private medical office is subject to licensing.

But anyone who has ever be involved in the process of obtaining permits understands how complex this procedure is and how much specific knowledge and skills it requires. Not to mention how much money and time you need to spend on it.

Today we will talk about the key aspects of licensing of medical practice.

Our service: License For Medical Practice

Document preparation process

Before submitting documents to the licensing commission, you must obtain the sanitary-epidemiological conclusion on the compliance of the existing premises with the requirements of sanitary norms and regulations on medical practice.

Such a conclusion is issued within 10 days. Once you have got the conclusion, you can prepare a package of documents to be submitted to the licensing authority affiliated with the Ministry of Health of Ukraine.

Related article: Obtaining SES (Sanitary And Epidemiologic Service) Conclusion In Ukraine: Problem Projects From Our Practice

In fact, you need to submit 3 documents when applying for a license to practice medicine: 

  • Application for the license; 
  • Statement on the condition of the material and technical base and the availability of personnel; 
  • List of documents submitted.

In order to avoid any problems or mistakes, it is advisable to use the forms of these documents. You can find samples of these documents on the web portal of the Verkhovna Rada of Ukraine.

Application for a license and a list of documents submitted

Both documents are quite easy to fill in, that’s why we have combined them into one section.

In the application form, you shall specify the details and data of the company. But you may face some problems, if you specify the abbreviated or incorrect name of the business entity, wrong code, address, or forget to sing the application, etc. You should carefully and completely fill in all the sections of the Application.

A list of documents is a list of documents that are submitted together with the application. You won’t face many problems when completing this document. But you shall specify here only documents that are submitted to the Ministry of Health of Ukraine.

Information on the condition of the enterprise material and technical base, the availability of personnel, indicating their educational and qualification level 

This is the most difficult document to fill in. As a rule, applicants make a lot of mistakes in it.

We will elaborate on each paragraph and provide you with tips to fill them in.

Paragraph 1: Information about the health care workers’ specialties that will be used in medical practice. Here you should specify the specialties corresponding to your activity. This may include paediatrics, dentistry, and general family medicine. You may face some problems, when specifying the specialties that are not subject to licensing, according to the requirements of the License Terms.

Related article: Obtainment Of A Medical Practice License For Ophthalmologist: Most Frequently Asked Questions From Our Practice

Paragraph 2. The types of health care services. The methods to be used by the health care institution depend on the specialty. It is important that the methods correspond to the main professional tasks and responsibilities of the specialists, taking into account the institution activity profile and the level of health care services.

Paragraph 3 refers to the sign at the entrance to health care institutions. You shall specify the name of the legal entity and a type of institution. You may specify the EDRPOU code and address, but this is not required. The type of health care institution depends on the functional purpose (it is opened for), the type of medical specialties, the category of patients and the type of health care services. 

In Paragraph 4, the applicant shall specify the organizational documents and the structure of the health care institution. Here you shall specify the details of the document on the establishment of the the health care institution. This may be the Charter or Regulations, which forms the basis of the health care institution establishment. 

Paragraph 5.Details of the document confirming the right to use the premises. The premises can be either owned, or rented. Here you should specify the extract from the State Register of Real-Estate Property Rights or the Lease Agreement for the premises, i.e. the grounds to be located in the premises. But there are some nuances!

Such agreements are very often concluded before the registration of the company, in order to avoid taxes. This can lead to a refusal to grant a license.
 
Lease agreements with a term of more than 3 years are subject to notarization and state registration (this applies to non-residential premises)

Related article: Requirements To Area And Structure Of Doctor’s Rooms

Paragraph 6. Details of the Sanitary and Epidemiological Certificate of the premises. The Sanitary and Epidemiological Certificate shall be indicated depending on the type of health care services provided. The applicants may face some problems when filling in the details of the Certificate. 

Paragraph 7. Information on the material and technical base shall be specified for all locations used for  medical practice. This paragraph is one of the most challenging to fill in.

The most common mistakes:

  • The rooms are not separated according to their functional purpose. 
  • Indication of offices used for undeclared specialties. If you have specified a separate office in this paragraph used to carry out medical practice under the specialty that was not indicated in the application or in paragraph 1, you are likely to get a refusal. 
  • Failure to specify all rooms necessary for the declared specialties. This means that if you have an operating room for “surgical intervention”, you shall also have a recovery room. 

Attention! In this paragraph, you shall specify the name of the room, the doctor’s specialty, the doctor’s working hours, the area of each room and the equipment to be used there. 

  • Applicants often make mistakes in the fourth field of this paragraph. First of all, it is necessary to indicate the medical equipment and medical devices required to provide the specified scope of health care services.
  • You shall specify the equipment used for each room, as well as the condition of this equipment, the year of manufacture, the manufacturer, the model. It is advisable to specify each item (equipment) indicated in the list of available equipment so that there is no formal grounds for refusal. 

Paragraph 8 refers to metrology calibration of the equipment.

Common mistakes: Applicants often fail to indicate full details of the documents on metrological verification and do not specify all measuring instruments that are subject to verification. 

Paragraph 9 and 10 shall include information on compliance of physicians (including the head of the institution) with educational and qualification requirements, junior specialists - with medical (pharmaceutical) education, and other specialists working in the institution. 

Note!  No vacant positions shall be specified. 

Related article: Our Practical Experience Of Pediatricians And Family Doctors Licensing Under Medical Reform In Ukraine

Paragraph 11. Information about the length of service of the director of the health care institution and the individual entrepreneur shall be specified in accordance with the employment record book for the past 5 years or the details of the valid license.

You shall indicate the data from the employment record book: record of employment (place of work) and the details of the document, which serves as a basis for the employee’s employment or dismissal. It is important to remember that an employee of a state-funded institution, who works in a managerial position, can not work part-time. 

Related article: General And Medical Director At Medical Institution

That was the final step in completing the Statement. But don’t forget to number the pages, to sew them together, to certify by the authorized representative and to specify the Statement date.

Procedure for obtaining a Medical License 

Following the receipt of all the necessary documents, the licensing authority shall make a decision within 10 business days. In practice, you can check the result on the official website of the Ministry of Health of Ukraine within 2 weeks.

 

After receiving a positive decision on the license issue, you shall pay a license fee in the amount of one subsistence level at the time of obtaining a license.

This fee shall be paid not later than in 10 business days upon the publication of the decision to issue a license. After making a payment, you can get the license in the form specified in the application. 

Our service: License For Medical Practice

If you have any questions related to the procedure of obtaining a Medical License, don’t hesitate to contact our specialists. 

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