License for Business Activities in Medical Practice

The medical business in Ukraine is subject to strict regulation, and obtaining a license for conducting medical practice is a mandatory requirement for legal operation. The lack of a license not only constitutes a violation of the law but also exposes your business to significant risks, including fines and suspension of operations.

Are you planning to open a private medical office, a modern clinic, or expand the range of medical services? Obtaining a license is the first and most crucial step, and legal support in acquiring the license is essential for your peace of mind and successful start. In this article, we will outline the key aspects of medical practice licensing to help you successfully navigate this process.

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What Is a Medical License and Who Needs It?

A license for conducting business in medical practice is an official permit issued by the Ministry of Health of Ukraine to business entities, authorizing them to perform specific types of medical activities. It is required for:

• Private doctors planning to run an individual practice (sole proprietors).
• Medical centers, clinics, hospitals, laboratories, diagnostic centers, and other medical institutions (legal entities).
• Sole proprietors who plan to open a medical institution and hire medical staff.

Please note: A medical license is mandatory for all types of medical services defined by the Licensing Conditions for conducting business in medical practice, approved by the Cabinet of Ministers of Ukraine. Your Classification of Economic Activities (KVED) must correspond to the type of activity declared.

Legislative framework:

• The Law of Ukraine "On Licensing of Types of Economic Activities."
• Licensing Conditions for Conducting Business in Medical Practice (Resolution of the Cabinet of Ministers of Ukraine No. 285, dated 02.03.2016).
• Other regulatory legal acts governing the healthcare sector.

Requirements for Licensees to Obtain a Medical License

To obtain a license for conducting business in medical practice, the following requirements must be met:

1.      Qualification requirements for medical personnel: The presence of appropriate medical education, specialist certificates, qualification certificates, and other documents as required by law. It is important to consider the requirements for work experience and ongoing professional development.

2.      Requirements for premises and equipment: The premises must meet sanitary and hygienic standards, building regulations, and fire safety requirements. The premises should be non-residential and owned or leased by the licensee. Necessary medical equipment and inventory for carrying out the declared activities must be available. Accessibility for people with limited mobility should also be ensured.

3.      Sanitary and hygienic requirements: Compliance with sanitary standards and regulations established for medical institutions, as approved by the Ministry of Health.

Procedure for Obtaining a Medical License

The process of obtaining a medical practice license includes the following stages:

1.      Document preparation: Collecting a complete set of documents in accordance with the Licensing Conditions.

2.      Application submission: submitting the application and other required documents to the Ministry of Health of Ukraine.

3.      Document review: The ministry reviews the submitted materials within 10 business days.

4.      Decision-making: A decision is made regarding the issuance of the license, refusal, or dismissal of the application.

5.      License issuance: The Ministry of Health issues the corresponding order, which is published on the official website. Subsequently, information about the licensee is entered into the Licensing Register. Since January 1, 2017, licenses are not issued on paper.

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List of Required Documents

The list of documents is defined by the Licensing Conditions and includes the following:

• Application for obtaining a license.
• Information on the material and technical base and staff qualifications.
• Description of documents attached to the application.

The current list of documents is outlined in the Licensing Regulations and can also be reviewed on the Ministry of Health's website or on our page "Medical Licenses in Ukraine."

Cost of Obtaining a License

The cost of a license for conducting medical practice business consists of a licensing fee. The amount of this fee is determined by legislation and is tied to the minimum wage for working-age individuals. As of the date of writing this article, the administrative fee is equivalent to 1 minimum wage for a working-age person.

The current amount should be verified on the Ministry of Health's website or in the order to issue the license, where payment details and the exact amount to be paid by the licensee are always specified.

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Refusal to Issue a License: Reasons and Solutions

The most common reasons for refusal include:

• Incomplete set of documents.
• Non-compliance with qualification requirements.
• Non-compliance of premises and equipment with established requirements.
• Providing false information.

In case of refusal, the decision can be appealed through administrative or judicial procedures.

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Re-registration, Termination, and Suspension of License

1.      Re-registration of a license: в In the event of the death of a licensee who is a sole proprietor, the right to conduct medical activity may be transferred to their heir. To do so, the license must be re-registered with the licensing authority. The re-registration process occurs within 30 calendar days from the moment the heir acquires the corresponding right, provided they meet the Licensing Regulations.

2.      Termination of the license: A licensee may voluntarily terminate the license either partially or fully for a specified period, upon their request.

3.      Suspension of the license: This refers to the temporary revocation of the business's right to carry out all or part of the activities specified in the license. The Ministry of Health of Ukraine makes the decision to suspend the license in the case of violations of the Licensing Conditions. Information about this is entered into the Licensing Register.

Liability for Conducting Medical Practice Without a License

Conducting medical practice without the proper license is considered an administrative offense and carries liability in accordance with current legislation. Penalties are imposed for such violations, with the amount depending on the circumstances of the violation.

Legal Assistance in Obtaining a Medical License

Licensing medical services is an important and often complex stage for any medical institution. It requires not only time for document preparation but also staying updated on legislative changes to avoid mistakes.

The services of qualified lawyers help identify potential pitfalls, accelerate the process of obtaining a medical practice license, and ensure compliance with all legal requirements. Our team, including a medical law specialist, offers a full range of services for medical activity licensing, which includes:

• Detailed licensing consultations: We will provide comprehensive answers to your questions and offer professional recommendations tailored to the specifics of your business.
• Thorough document analysis and complete package: We will review your existing documents, help gather the necessary certificates, and ensure flawless preparation of all paperwork in accordance with current requirements.
• Representation of your interests with the Ministry of Health and other government authorities: We will handle all communications with government bodies, saving you time and relieving you of stress.
• Professional appeal of license denial decisions (if necessary): If you encounter difficulties with licensing in the form of a refusal, we will provide qualified legal protection of your interests and a legal resolution to the situation.

Don't delay with licensing your clinic or private medical practice! Submit an application on our website or call us. Our experts will provide you with all the necessary information and explain how we can assist you.