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: Expanded the Ministry of Health Medical Licence for a Children’s Rehabilitation Centre

Reading time: 5 min.

Modern rehabilitation for children requires a comprehensive multidisciplinary approach: from accurate diagnostic imaging to the work of specialist professionals. A medical rehabilitation institution located in Western Ukraine approached the lawyers at Prikhodko & Partners with the objective of scaling its capacity and opening a new facility in another district centre.

Main challenges of the case

  1. Preparation of the document package (Application for the expansion of medical practice activities, Information on the state of the material and technical base, and availability of personnel indicating their educational and qualification levels) in accordance with the updated Appendix 2 to the Licensing Conditions.
  2. Adding new positions for rehabilitation professionals and specialists (physical therapists, occupational therapists, assistants, speech and language therapists, clinical psychologists), for which the regulator imposes strict requirements regarding diplomas, specialisation and professional development courses.
  3. Licensing diagnostic equipment: opening an ultrasound diagnostic office and a radiology department (procedure room and control room) in compliance with radiation safety standards, including protective equipment and dosimetry.
  4. Accessibility requirements: confirmation of building accessibility for persons with disabilities and persons with reduced mobility in accordance with DBN standards.

What exactly was added to the licence?

As a result of the audit and preparation of documents, the licence was expanded in the following areas:

  1. A new address for carrying out activities.
  2. Medical specialties: ultrasound diagnostics; radiology.
  3. Specialties of healthcare professionals (rehabilitation care): physical therapy, occupational therapy, clinical psychology, speech and language therapy.
  4. Specialties of healthcare specialists (junior specialists/assistants): radiology (radiographers), physical therapy (physical therapist assistants), occupational therapy (occupational therapist assistants).

Stages of legal support for the procedure

Audit of the material and technical base and room layout

First of all, our lawyers conducted an audit of the material and technical base and the layout of the rooms. The equipment of seven specialised zones with a total area of more than 500 sq. m was reviewed and legally documented.

For example, the speech and language therapist’s room (26.2 sq. m), in addition to standard furniture, is equipped with a magnetic board, PECS alternative communication cards, chewing and swallowing trainers, dysphagia correction sets and thematic Kubuvannia card sets.

The physical therapist’s room (49.3 sq. m) includes a GH3 ceiling lift, a Fit-On RunMed rehabilitation treadmill, wide therapy tables, parallel bars for walking with obstacles, universal stairs for gait training with an inclined surface, balance cushions of various types and sizes, wall bars, yoga mats and examination couches.

The occupational therapist’s room (18.6 sq. m) contains fine motor rehabilitation tools, pinch gauges, DK-25 dynamometers and self-care devices for dressing, putting on footwear and securing cutlery.

The clinical psychologist’s room (14.5 sq. m) is equipped with a standardised diagnostic environment.

The ultrasound diagnostic office (17.7 sq. m) has a Toshiba Aplio 500 expert-class diagnostic system installed, as well as specialised furniture and measuring equipment.

The radiology diagnostic unit comprises two rooms: a procedure room — 47.7 sq. m and a control room — 9.9 sq. m, equipped with an Optima digital system, a negatoscope, a full set of X-ray protective equipment and dosimetry controls.

Qualification audit of personnel

At the next stage, a qualification audit of the personnel was conducted, covering more than 30 employees. Particular attention was paid to confirming the qualifications of the multidisciplinary team by comparing the specialists’ basic medical/educational qualifications with the requirements for rehabilitation professional positions.

The availability of specialist certificates, professional development certificates and qualification categories was reviewed. In our case, the personnel had documents confirming completion of new training programmes in rehabilitation medicine, physical therapy and occupational therapy during 2023–2025.

The lawyers also paid particular attention to the proper legal formalisation of the primary place of employment and secondary employment of the medical director, doctors and mid-level medical personnel.

Preparation and support of the licensing file before the Ministry of Health

A comprehensive package of information was prepared using the current form — Appendix 2 to the Licensing Conditions — which, among other things, currently requires the inclusion of: information on the agreement for the disposal of hazardous medical waste, reports on accessibility of the premises for persons with reduced mobility, and title documents for the real estate.

Thanks to the professional approach of our medical lawyers, the result was an order of the Ministry of Health of Ukraine approving the expansion of the institution’s medical licence without remarks and without leaving the application without consideration.

Advice for medical and rehabilitation institutions opening a new branch

  1. Do not open rooms without expanding the licence: providing medical or rehabilitation services at a new address before publication of the Ministry of Health order may result in administrative fines and a risk of licence revocation.
  2. Review the educational documents of specialists you employ at your medical institution: for positions such as “speech and language therapist” or “clinical psychologist”, it is important that the basic education (special education, psychology) and specialisation certificates fully comply with the relevant regulatory qualification references.
  3. Accessibility is a priority in a licensing audit: a valid certificate/report confirming access for persons with reduced mobility, prepared by a certified expert, is a mandatory condition for licensing premises used for any type of medical activity.

Why should opening a clinic or expanding a licence be entrusted specifically to Prikhodko & Partners?

We do not learn from your cases. We have already guided hundreds of clinics, private medical offices and large rehabilitation centres through the “Ministry of Health filter”.

We work as an antidote to refusals. An error in a single field of the Information on the Material and Technical Base may cost months of equipment downtime and rent. With us, you can begin seeing patients on time.

Deep knowledge of the standards. From the size of an X-ray room and protective curtains to the nuances of diplomas for clinical psychologists and speech and language therapists — we know the sector from the inside, not from textbooks.

You treat people — we take on the regulatory pressure.

Are you planning to open a new branch of a rehabilitation centre, add diagnostic or rehabilitation specialties, or expand an existing medical licence? Submit a request — the medical lawyers at Prikhodko & Partners will support the preparation of documents and the procedure before the Ministry of Health.

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1 question

Is your rehabilitation centre opening a new address?

Yes
No
2 question

Are you planning to add new rehabilitation specialties?

Yes
No
3 question

Are you opening an ultrasound or radiology office?

Yes
No
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Юридичні послуги для медичного бізнесу та лікарів

Development of documentation for a medical institution under Resolution No. 1158 during an air raid alert Opening a medical business in Ukraine for foreigners Turnkey medical business launch License for a diagnostic center License for a Multispecialty Medical Center Medical license for a rehabilitation center License for a Medical Office in Educational Institutions and Enterprises Cosmetic notification Medical waste treatment contract Amendments to the precursor license Amendments to a medical practice license Certificate of Good Standing Termination of a medical practice license CPD (continuing professional development) provider registration License to sell medicines at gas stations Rehabilitation Services License Medical license for sole proprietors (Doctors) Licensing of the production of veterinary drugs Legal protection of a plastic surgeon Legal protection of a dentist Registration of dietary supplements Testing laboratory certification State registration and re-registration of medicinal products in Ukraine Support in concluding an NSZU contract Accreditation of a medical institution Medical services contract Legal support of medical institutions Verification of Medical Practice Licensing Conditions Medical practice license extension License to sell medicines License for precursors in Ukraine Licensing of the production of medicinal products in Ukraine Medical practice license in Ukraine License for import of medicinal products Registration of disinfectants Medical device certification Registration of medical devices Legal support for clinical trials Registration of medicines Laboratory accreditation GMP certificate Certification of laboratory glassware and test tubes Implementation of paid medical services in the KNP: legal support and consulting Advertising of medicines: legal support of advertising and audit of advertising materials License for veterinary practice Development of standard operating procedures (SOP) for medical facilities Report on the availability of premises for groups with limited mobility License for general trade in medicinal products Pharmacy license Legal protection of the doctor Licensing of medical facilities License for cosmetology services Dental practice license in Ukraine Certification of detergents in Ukraine Certification of cosmetics (cosmetic products)