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.

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Case: Scaling a Municipal Rehabilitation Centre in the Ternopil Region — Expanded the Medical Licence

Reading time: 6 min.

Today, the development of rehabilitation care in Ukraine is not only a state priority but also a critical necessity for the high-quality recovery of military personnel and civilians. Healthcare institutions are actively purchasing innovative equipment, opening new departments and developing additional locations.

However, for the head of a medical or municipal institution, expanding rehabilitation facilities is always a significant regulatory challenge. The acquisition of modern systems, mechanotherapy equipment or the installation of diagnostic equipment automatically requires strict compliance with the Licensing Conditions for carrying out medical practice.

The main risk for the head of an institution is that operating at a new location or using newly purchased equipment without making changes to the Ministry of Health licensing register is considered unlicensed activity. This may result in disruption of contracting with the NHSU under rehabilitation packages, as well as reputational and financial losses.

The medical lawyers of Prikhodko & Partners share a practical case involving the successful expansion of a medical licence for a large municipal institution in the Ternopil Region.

The head of a large municipal healthcare institution (KNP) in the Ternopil Region approached the medical law practice of Prikhodko & Partners. The institution implemented a large-scale project to develop its rehabilitation services:

  1. Opening a new address: a separate location was created with spacious rehabilitation halls and diagnostic rooms.
  2. Investment in the material and technical base: expensive mechanotherapy equipment, gait rehabilitation systems and a range of measurement and diagnostic devices were purchased.
  3. Engaging a multidisciplinary team: a fully functioning rehabilitation and diagnostic team was formed.

It was necessary to amend the licensing file as quickly as possible, add a new address for carrying out medical practice to the licence and formalise the provision of services in the following specialties:

Diagnostic unit: radiology, ultrasound diagnostics;

Rehabilitation cycle: physical therapy, occupational therapy, speech and language therapy;

Psychological care: clinical psychology.

Common pitfalls: where municipal institutions most often receive refusals from the Ministry of Health

Expanding a municipal institution of this level involves specific risks that not every general-practice lawyer is familiar with:

  1. Material and technical equipment lists: requirements for rehabilitation departments are regulated by Order of the Ministry of Health of Ukraine No. 995 dated 31 May 2023. Any inaccuracy in a serial number, the name of a rehabilitation device or the absence of minor metrological equipment such as goniometers or dynamometers in the Information on the Material and Technical Base may result in the documents being returned.
  2. Radiation safety: adding radiology requires special confirmation of the safety of the premises and authorisation from the State Nuclear Regulatory Inspectorate, as well as compliance with radiation safety standards.
  3. Mismatch in job classifications: legislation clearly distinguishes medical specialties from the specialties of rehabilitation professionals with higher non-medical education. Physical therapists and occupational therapists must comply with current qualification requirements and professional standards.
  4. Accessibility requirements (DBN V.2.2-10:2022): the new rehabilitation location must be fully barrier-free: door openings of at least 90 cm, compliant ramps, specialised sanitary facilities and an official expert report on the inspection of the premises.

Project implementation algorithm by the lawyers of Prikhodko & Partners

Step 1. Technical and sanitary audit of the new location

  • The areas of consultation rooms, occupational therapy halls and kinesitherapy halls were reviewed for compliance with DBN standards.
  • An expert Accessibility Report for persons with reduced mobility was prepared.
  • Existing agreements for the disposal of category B and C medical waste at the new address were reviewed.

Step 2. Systematisation of the material and technical base and equipment

  • All purchased rehabilitation devices, systems and diagnostic equipment (ultrasound system and X-ray unit) were identified in detail.
  • Information on the state of the material and technical base was prepared in accordance with the official equipment lists.

Step 3. Personnel screening of the multidisciplinary team

  • The educational and qualification documents of radiologists, ultrasound diagnostic physicians, physical therapists, occupational therapists, speech and language therapists and clinical psychologists were reviewed.
  • The validity of qualification category certificates, specialist certificates and the required number of Continuing Professional Development (CPD) points was checked.

More about CPD provider registration

Step 4. Preparing the package and support before the Ministry of Health of Ukraine

  • An official application for the expansion of medical practice activities and detailed Information describing the new address and new specialists were prepared.
  • The package was submitted through the Ministry of Health Single Window.
  • Support was provided throughout the review until the Ministry of Health issued an order on the expansion of medical practice activities.

Project results

Parameter Before engaging medical lawyers Result of the work of Prikhodko & Partners
Place of practice Operations exclusively at the previous licensed address The new address was officially legalised in the Ministry of Health licensing register
List of specialties Basic medical specialties without modern rehabilitation services Added: radiology, ultrasound diagnostics, physical therapy, occupational therapy, clinical psychology, speech and language therapy
Material base New rehabilitation devices and equipment without the right to operate them 100% compliance with the Equipment List
Institutional safety Risk of rehabilitation packages under the NHSU being blocked An up-to-date licensing file was prepared, with full readiness for inspections
Legalisation timeframe Risk of the procedure being delayed by 3–6 months due to refusals Ministry of Health order expanding the licence obtained without remarks

Why do heads of municipal healthcare institutions and medical centres choose Prikhodko & Partners?

Expanding a municipal or private medical institution leaves no room for errors in wording. An error in a single field of the information submitted may mean a refusal, lost time for repeated review, unused equipment and financial losses.

Prikhodko & Partners provides:

  • Sector expertise: hundreds of successfully obtained and expanded medical licences for municipal institutions, private hospitals and rehabilitation centres throughout Ukraine.
  • Comprehensive turnkey support: from coordinating architectural accessibility of the premises to protecting the client’s interests before regulatory authorities.
  • Remote support: full legal management of the project in any region of Ukraine through digital channels or the Ministry of Health Single Window.

Frequently asked questions from heads of healthcare institutions (FAQ)

1. Within what period must a municipal institution notify the Ministry of Health about opening a new address or adding doctors?

Under the Licensing Conditions, the licensee must officially submit documents regarding changes in information (a new address, new equipment or personnel) within one month from the date on which such changes occur. If previously undeclared specialties are introduced at the new address, the procedure for expanding the licence must be completed.

2. What is the difference between notification of changes and expansion of a licence?

If a healthcare institution opens an additional consultation room for the same specialties already included in the licence, a notification of changes in information is submitted. If fundamentally new medical or rehabilitation specialties are added, for example occupational therapy or speech and language therapy for the first time, an application in the prescribed form is submitted to expand the medical practice licence.

Are you planning to expand a medical institution or open a rehabilitation department?

Entrust the legal aspects to professionals so that your material and technical base can deliver results without fines or downtime.

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1 question

Is your medical institution opening a new address?

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2 question

Are you planning to open a rehabilitation department?

Yes
No
3 question

Are you adding new medical or rehabilitation specialties?

Yes
No
4 question

Are you adding radiology or ultrasound diagnostics?

Yes
No
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Юридичні послуги для медичного бізнесу та лікарів

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