Licensing of Medical Activities or Practice

Medical License Issuance Kyiv

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Medical License

A medical practice license is a state-issued permit issued by the Ministry of Health (MOH) that certifies the right of an economic entity to provide medical services, subject to compliance with mandatory requirements.

Our law firm will provide all necessary services related to obtaining a medical practice license in Kyiv, which will help reduce the cost and time spent on this procedure.

How to obtain a medical license?

Obtaining a medical license

Medical practice is an economic activity in the health care sector carried out by entities that meet unified qualification conditions, with the aim of providing medical care and medical services.

According to the legislation of Ukraine, the medical practice of a healthcare institution or an individual entrepreneur requires obtaining a medical license and compliance with a number of qualification, organizational and other special requirements.

Required documents for obtaining the license:

• an application of the prescribed form;
• an SES conclusion certifying that the premises where medical services will be provided comply with sanitary norms and rules established in the health sector (issued at the place of activity);
• documents confirming that the material and technical base meets the stated requirements;
• documents confirming the compliance of the regulatory framework necessary for carrying out the activity;
• documents confirming the qualifications of the personnel.

For a correct description of information about the material and technical base, specialties (physicians and junior specialists) for which the applicant plans to conduct medical practice, it is necessary to indicate them strictly following the nomenclatures approved by MOH orders. In addition, it should be taken into account that all premises must comply with state building codes approved for healthcare institutions, and their furnishing with medical equipment and devices must comply with the equipment lists approved by MOH orders. It should also be remembered that using a single room to provide medical services for different functional directions is prohibited. At the same time, the use of a premises by different business entities is permitted (provided the appropriate documents are available: lease agreements, acts). Separate reception rooms should be provided for pediatric, maternity (gynecological), dermatovenereological, infectious, tuberculosis and psychiatric (psychosomatic) departments.

The regulatory framework necessary for conducting medical practice includes approval of the following documents: the charter, staffing schedule, list of equipment, records nomenclature, rules for patient stay, rules and standards for nursing care and procedural interventions, hand washing and disinfection, staff algorithms for emergency situations, and provisions on the system for quality control of work performance. In addition, it is mandatory to specify the accounting and reporting statistical forms of primary documentation used for the declared specialties (approved by MOH orders).

When providing a description of the staff composition, it should be remembered that specialist physicians must meet the approved qualification requirements, for which, in particular, they must undergo professional development (confirmation) of their qualification category every five years.

The licensee must notify the licensing authority within ten days of the occurrence of any changes in the documents confirming the above information, as well as of the termination of activities at the declared address.

The fee for a medical license is fixed at the level of one minimum wage in effect on the date of the licensing authority’s decision. Until 1.12.2015 this amount was determined as 1218 UAH.

A fee of 85 UAH is established for reissuing or issuing a duplicate.

The fee for issuing a copy of the license is 17 UAH.

It should be noted that payment for the administrative service of issuing a medical license is made only after the licensing authority has made a positive decision on your application. After submitting a document confirming payment, the license will be prepared and issued no later than three working days.

Since the beginning of 2010, this type of license has been issued for an unlimited period.

To properly prepare such a large package of documents, you may need a lawyer. In this case, it is also necessary to issue a power of attorney to represent your interests.

Types of medical activities subject to licensing

Medical care is the professional medical activity of healthcare institution staff aimed at prevention, diagnosis, treatment and rehabilitation of various health conditions: diseases, poisonings, injuries, pathological conditions, as well as pregnancy and childbirth.

The types of medical activities subject to licensing include the following medical care:

• emergency;
• primary;
• secondary (specialized);
• tertiary (highly specialized);
• palliative;
• medical rehabilitation.

Main requirements for economic entities wishing to carry out medical practice:

• availability of premises that comply with sanitary rules and norms;
• equipping the technical base with necessary medical equipment, instruments, and medical devices. All measuring equipment is subject to mandatory metrological verification;
• having in the staff the necessary employees to provide the declared medical services – physicians, pharmacists, junior specialists;
• attestation of employees in accordance with rules established by law;
• compliance with requirements regarding mandatory medical examinations of employees;
• ensuring free access to the premises for persons with limited physical abilities.

It should be taken into account that the licensee has the right to provide medical services in accordance with the medical and pharmaceutical specialties and the specialties of junior specialists declared in the submitted documents.

In their medical practice, the licensee may use only medicines authorized by the MOH of Ukraine, as well as methods of prevention, diagnosis, treatment and rehabilitation.

Contact the specialists of our company who:

• will help you understand all the subtleties of the extensive list of licensing requirements;
• will provide qualified representation of your interests in all instances in Kyiv;
• will prepare and submit the document package;
• will obtain the medical license promptly and with minimal involvement from you.

LEGISLATION:

Law of Ukraine “On Licensing of Types of Economic Activity” dated 02.03.2015 № 222-VIII;

Law of Ukraine “Fundamentals of the Legislation of Ukraine on Health Care” dated 19.11.1992 № 2801-XII;

Order of the Ministry of Health of Ukraine “On Approval of Licensing Conditions for Conducting Economic Activity in Medical Practice” dated 02.02.2011 № 49;

Order of the Ministry of Health of Ukraine “On Further Improvement of Physicians’ Certification” dated 19.12.1997 № 359;

Order of the Ministry of Health of Ukraine “On Certification of Junior Specialists with Medical Education” dated 23.11.2007 №742.

DBN B.2.2-10-2001 “Buildings and Structures. Healthcare Institutions”, approved by the Order of the State Construction Committee of Ukraine dated January 4, 2001 № 2 and put into effect on April 1, 2001