Head of Medical Law Practice
Specializes in medical, corporate, and migration law. Has extensive experience working with medical and pharmaceutical businesses, particularly in licensing, circulation of medicines, and comprehensive legal support of healthcare institutions, including corporate, tax, and employment matters, as well as market entry projects of foreign companies into Ukraine.
Case: Expanded the dental clinic’s medical licence and added radiology
The medical business in Ukraine operates under strict control by state authorities. Any inaccuracy in an application or information statements may result in refusal to issue or update documents, while failure to comply with new requirements may lead to suspension of operations.
Recently, the owner of an operating dental medical centre in the Lviv region approached Prikhodko & Partners with the need to make substantial changes to the licensing file.
The client’s request consisted of 3 key tasks:
- Expansion of the staffing structure: Add 5 new dentists and 5 nurses to the existing licence.
- Expansion of services: Add a new medical specialty — radiology, which required a specific approach to the material and technical base.
- Compliance with new Ministry of Health requirements: Fulfil the obligation to officially enter into a medical waste treatment agreement and confirm accessibility of the premises for persons with reduced mobility.
Under the current legislation of Ukraine, where the range of services or staffing is expanded to include new specialties, the business entity must officially notify the licensing authority — the Ministry of Health of Ukraine — within one month. Performing medical procedures by doctors who are not listed in the current information statements constitutes a serious violation of the Licensing Conditions and may result in fines or even complete revocation of the medical practice licence.
Step-by-step implementation of the “Turnkey Medical Licence” project
Step 1: Personnel audit and legalisation of staff
Our medical lawyers conducted a thorough review of the new employees’ education and qualification documents. Diplomas, valid certificates and continuing professional development (CPD) documents were analysed. A package of documents was prepared and submitted for changes to the medical licence.
Step 2: Expansion of the licence — the specialty of “radiology” was added
We prepared detailed Information Statements on the state of the material and technical base and availability of equipment (X-ray equipment) in accordance with the official Equipment Standards.
Step 3: Compliance with environmental and accessibility requirements
Accessibility (DBN V.2.2-10:2022): an inspection was organised and a report was prepared by a construction expert, who issued an official Conclusion on the accessibility of the premises for persons with reduced mobility (availability of a compliant ramp, appropriate doorway widths and an accessible toilet).
Medical waste agreement: we reviewed and selected a company holding a valid licence from the Ministry of Economy for medical waste treatment. We assisted with concluding the agreement.
Project stages and result
| Project stage | Actions of the medical lawyer | Result |
|---|---|---|
| Audit of the material and technical base and personnel | Review of nurses’ certificates and the premises intended for X-ray services. | Risks were eliminated and the personnel were fully legalised. |
| Agreements and Conclusions | Obtaining the accessibility conclusion for persons with reduced mobility and the waste disposal agreement. | Compliance with DBN requirements and sanitary standards was ensured. |
| Submission to the Ministry of Health | Preparation of the application package and information statements. Organisation of document submission. | The licence expansion was obtained quickly and without refusals. |
Result for the dental centre
Thanks to the coordinated work of our lawyers and their in-depth understanding of the Ministry of Health procedures, the medical institution legally launched new services and expanded its staff. The institution operates fully legally, without any risk of fines or loss of patient trust.
Do you need to expand your medical licence?
Do not put your medical business at risk. If you need to add a doctor to the licence, open a new office or expand the list of specialties, entrust this work to professionals.
Contact the medical lawyers at Prikhodko & Partners to review your licensing file and obtain legal support for making changes to your medical licence.
Юридичні послуги для медичного бізнесу та лікарів
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