Publication date: 12.07.2024
The procedure for obtaining a Medical Licence
Medical practice requires a high level of professionalism and compliance with strict quality and safety standards. In Ukraine, to practice medicine, you need to obtain a licence, which confirms that a medical institution or practitioner meets the requirements of the law. In this article, we will review the procedure for obtaining a medical licence, the regulatory framework, the main requirements for applicants, the stages of the licensing process and the possible consequences of non-compliance with the licence conditions.
Legal and regulatory framework
The process of obtaining a medical licence in Ukraine is regulated by several key legal acts:
TheLaw of Ukraine "On Licensing of Economic Activities":
- Defines the general legal framework for licensing of economic activities, establishes the list of activities subject to licensing, the procedure for obtaining a licence and requirements for licensees.
Law of Ukraine "Fundamentals of the Legislation of Ukraine on Healthcare":
- Defines the basic legal, organisational and socio-economic principles of healthcare, establishes the procedure for the provision of medical care and licensing of medical activities.
Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Procedure for Licensing Medical Practice":
- Regulates the procedure for granting a licence to carry out medical activities, sets requirements for medical practice entities and the procedure for submitting documents.
Order of the Ministry of Health of Ukraine "On Approval of Licensing Conditions for Conducting Business Activities in Medical Practice":
- Sets out licensing conditions for medical practice entities, including requirements for material and technical facilities, staff qualifications and other aspects.
Main requirements for applicants
In order to obtain a medical practice licence, a business entity must meet a number of requirements set out in the legislation. The main requirements include:
Registration of a legal entity or individual entrepreneur:
- The applicant must be registered as a legal entity or individual entrepreneur in accordance with the laws of Ukraine.
Compliance with the material and technical base:
- The business entity must have the necessary material and technical base to carry out medical activities, including premises, equipment, medical instruments and other means that meet the established standards.
Staff qualifications:
- The business entity must have qualified employees who have the necessary knowledge and experience to carry out medical practice. The staff must have appropriate education, training, certificates and licences.
Compliance withsanitary and epidemiological standards:
- A medical facility or practitioner must comply with established sanitary and epidemiological standards and regulations to ensure the safety of patients and staff.
Nocriminal record:
- The managers and employees of the business entity must not have any convictions for serious crimes, crimes against life and health, as well as other crimes provided for by law.
The procedure for obtaining a licence
The procedure for obtaining a medical licence includes several main stages:
Preparation of documents:
- The applicant must prepare a package of documents required to obtain a licence. This package includes:
- An application for a licence in the prescribed form.
- Copies of constituent documents (for legal entities).
- A copy of the state registration certificate.
- Documents confirming the availability of the material and technical base.
- Qualification documents of employees.
- Sanitary and epidemiological conclusions.
- Certificate of no criminal record for managers and employees.
- An application for a licence in the prescribed form.
Submission of anapplication to the licensing authority:
- The application together with the package of documents is submitted to the relevant licensing authority (for example, the Ministry of Health of Ukraine). The documents may be submitted in person, by mail or electronically through specialised portals.
Consideration of theapplication by the licensing authority:
- The licensing authority reviews the application and checks the submitted documents for compliance with the requirements of the law. If necessary, additional checks or requests to other authorities may be made.
Making a decision on granting a licence:
- Based on the review of the application and verification of the documents, the licensing authority makes a decision to grant or refuse a licence. In case of refusal, the applicant has the right to receive a reasoned response stating the reasons for the refusal.
Issuance of the licence:
- In case of a positive decision, the licensing authority issues a licence to the applicant to carry out medical activities. The licence may be issued in paper or electronic form.
Peculiarities of licensing certain types of medical activities
Licensing of different types of medical activities has its own peculiarities, depending on the specifics of the activity and the requirements of the law:
Alicence for outpatient medical activities:
- The licence is issued to medical institutions that provide outpatient services, including consultations, diagnostics, treatment and prevention of diseases. Requirements to the material and technical base, staff qualifications and sanitary and epidemiological conditions are determined by the relevant regulatory acts.
Licence for inpatient medical care:
- The licence is issued to medical institutions that provide inpatient medical care, including surgical interventions, intensive care, rehabilitation and other types of medical care. Particular attention is paid to the technical condition of the premises, availability of necessary equipment and qualifications of medical staff.
Licence for dental activities:
- The licence is issued to medical institutions and private practitioners providing dental services, including dental treatment, prosthetics, orthodontics and other types of dental care. The requirements for the material and technical base, sanitary and epidemiological conditions and qualifications of dentists are determined by the relevant regulatory acts.
Licence for laboratory diagnostics:
- The licence is issued to medical institutions that carry out laboratory diagnostics, including blood tests, urine tests, biopsies and other types of laboratory tests. The requirements for equipment, staff qualifications and compliance with quality standards are determined by the relevant regulations.
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