Support in the Accreditation of Healthcare Facilities
Accreditation of a healthcare facility in Ukraine is voluntary — and that is precisely why there is so much confusion around it. A facility is not obliged to undergo accreditation, but without an accreditation certificate it often loses out where it matters most: in access to certain packages of the Medical Guarantees Programme, in tenders, and in patients’ trust. The procedure itself is not a formality but a check of how systematically the facility has built its quality management, staffing and medical records. Dextra Law provides end-to-end support in accrediting medical facilities: we prepare the facility for the expert assessment, compile the document package and handle communication with the accreditation commission through to obtaining the certificate.
What accreditation of a healthcare facility is
Accreditation is the official recognition that a healthcare facility has the conditions in place for quality and timely medical care, that it complies with industry standards, and that its staff meet the unified qualification requirements. The legal basis is the Fundamentals of the Legislation of Ukraine on Healthcare No. 2801-XII and the Procedure for the Accreditation of a Healthcare Facility, approved by Resolution of the Cabinet of Ministers of Ukraine No. 765 of 15 July 1997 (as amended).
It is important not to confuse accreditation with licensing. A licence for medical practice is a mandatory permit, without which operating is not allowed. Accreditation is a voluntary confirmation of the level of quality that opens up additional opportunities but is not, in itself, a condition for starting work.
Accreditation is voluntary — so why does a facility need it
Following amendments to Article 16 of the Fundamentals of the Legislation, accreditation became voluntary — facilities undergo it by their own decision. The law expressly exempts pharmacy facilities from mandatory accreditation. The narrow range of activities for which accreditation was historically mandatory (in particular, those related to transplantation) was also moved largely onto a voluntary footing by the 2025 reforms, so the current requirement for a specific area is worth checking separately.
Despite being voluntary, accreditation gives a facility quite practical advantages:
- Access to NHSU funding. For certain packages of medical services paid for by the National Health Service of Ukraine, holding accreditation or a corresponding category may be a condition of participation.
- Reputation and competitiveness. For the private sector, the certificate is an argument in communication with patients, partners and insurers.
- Internal quality. Preparing for accreditation forces a facility to put its quality management system, staffing documentation and clinical processes in order — and that stays with the facility after the certificate is issued.
Which facilities undergo accreditation
Accreditation is available to healthcare facilities of all forms of ownership and at all levels of medical care. In practice, it is undergone by, among others:
- primary-care facilities — primary healthcare centres, outpatient clinics, feldsher-midwifery posts, and sole-practitioner doctors;
- secondary-care facilities — multidisciplinary and specialised hospitals, polyclinics, and diagnostic and consultative centres;
- tertiary (highly specialised) care facilities — regional and specialised centres and university clinics;
- private clinics and surgeries — in particular dental, rehabilitation, reproductive-medicine and aesthetic-medicine facilities;
- pharmacy facilities — on a purely voluntary basis, since they are not subject to mandatory accreditation.
Here it is worth distinguishing “who undergoes it” from “who actually needs it”. For some facilities, accreditation becomes a practical necessity when it is a condition of participation in certain packages of the NHSU Medical Guarantees Programme. For the rest, it is a matter of reputation and internal quality that the facility decides for itself.
Accreditation of a healthcare facility: the essentials at a glance
| Parameter | Details |
|---|---|
| Nature of the procedure | Voluntary (pharmacy facilities are not subject to mandatory accreditation) |
| Legal basis | Fundamentals of the Legislation No. 2801-XII; Procedure for Accreditation (CMU Resolution No. 765); amendments — CMU Resolution No. 42 (2025) |
| Authority | Main Accreditation Commission at the Ministry of Health and the accreditation commissions at regional administrations |
| Outcome | Status of “accredited” or a category — second, first or highest |
| Duration of the procedure | Must not exceed three months from the date of filing the application |
| Certificate validity | 3 years |
| Methods of submission | In person, by post, or electronically |
Who carries out accreditation
Accreditation is carried out by accreditation commissions, and which one applies depends on the facility’s form of ownership and the level of medical care:
- The Main Accreditation Commission at the Ministry of Health accredits state-owned facilities; municipal facilities providing tertiary care; and private facilities providing secondary and tertiary care.
- The accreditation commissions at regional administrations accredit municipal facilities providing primary and secondary care, as well as private facilities providing primary care.
- A separate main commission at the Ministry of Health accredits pharmacy facilities of all forms of ownership.
Correctly identifying which commission the application should go to is the first practical step, because an error here delays the procedure before it has even begun.
What changed in 2025
The accreditation procedure was recently simplified. Resolution of the Cabinet of Ministers of Ukraine No. 42 of 17 January 2025 amended the Procedure for Accreditation, in particular: it clarified which commissions an application should be filed with depending on the form of ownership and level of care, updated the application form, shortened the list of documents to be attached, and allowed documents to be submitted in three ways. At the same time, the Ministry of Health discontinued the separate register of accredited facilities — accreditation decisions are now published by the commissions themselves.
Which documents are needed
The list of documents was shortened after the 2025 changes, but the core of the package comprises:
- an application for accreditation in the updated form;
- documents confirming compliance with the accreditation standards and the functioning of the quality management system;
- staffing documents confirming the qualifications and training of medical and pharmaceutical personnel;
- documents on the facility’s material and technical resources and infrastructure;
- information on the keeping of medical records and observance of patients’ rights.
The commission scrutinises the staffing block and the quality-management-system documentation most closely — that is where there are the most details that are easy to miss.
The accreditation procedure: step by step
- Preparation and submission of the application. The facility prepares the document package and files an application with the relevant accreditation commission.
- Review of the application and formation of an expert group. The commission reviews the documents and appoints experts for the assessment.
- Expert assessment. The expert group assesses the facility’s compliance with the accreditation standards and draws up an expert opinion.
- Decision and certificate. The Main Accreditation Commission approves the opinion, after which an order of the Ministry of Health assigns the facility a status or accreditation category and a certificate is issued.
As a general rule, the whole procedure must be completed within three months from the date the application is filed. The certificate is valid for three years, after which, to confirm its status, the facility undergoes accreditation again.
The standards against which a facility is assessed
The experts look not at individual documents but at the system. The focus is on the management of the quality and safety of medical care, the qualifications and training of staff, the keeping of medical records, observance of patients’ rights, infection control, and the state of the material and technical base. A facility in which these processes exist only “on paper” rather than in reality risks being given a lower category or receiving remarks following the assessment.
Accreditation categories
Following accreditation, a facility receives the status of “accredited” or one of the categories — second, first or highest. The category reflects the level of compliance with the standards: the higher the result of the expert assessment, the higher the category assigned. For a facility, this is not just a status indicator but also an argument in its relations with partners and patients.
How Dextra Law supports the accreditation of a medical facility
Preparing for accreditation is largely work with documents and processes, not a single application. Dextra Law’s lawyers take on this part:
- Readiness audit. We assess the facility against the accreditation standards, review the staffing documentation, the quality management system and the material and technical resources, and record what needs to be addressed.
- Development and organisation of documents. We refine internal documents and regulations, prepare the application in the updated form and compile the full package for the specific commission.
- Choice of commission and submission. We determine which accreditation commission to approach based on the form of ownership and level of care, and submit the documents in a convenient way.
- Support during the expert assessment. We prepare the facility for the experts’ visit and support the process of assessing compliance with the standards.
- Maintaining the status. We track deadlines and support re-accreditation so that the certificate does not lapse.
Most remarks at accreditation arise not from weak medicine but from inconsistent documents and an “under-tuned” quality system. When these things are put in order in advance, the assessment goes smoothly and the facility receives the category it truly deserves.
Frequently asked questions
For healthcare facilities, accreditation is voluntary; pharmacy facilities are expressly exempted by law from mandatory accreditation. Areas for which it was historically mandatory (in particular, transplantation) were also moved largely onto a voluntary footing by the 2025 reforms, so the current requirement for a specific area is worth checking separately.
A licence for medical practice is a mandatory permit, without which the activity is unlawful. Accreditation is a voluntary confirmation of the level of quality that provides additional opportunities but is not a condition for starting work.
Primarily for access to certain NHSU packages, where accreditation or a corresponding category may be a condition of participation, and also for reputation, work with insurers, and putting internal processes in order.
Primarily for access to certain NHSU packages, where accreditation or a corresponding category may be a condition of participation, and also for reputation, work with insurers, and putting internal processes in order.
Under the Procedure for Accreditation, the period must not exceed three months from the date the application is filed.
An accreditation certificate is valid for three years. After that, to confirm its status, the facility undergoes re-accreditation.
It simplified the procedure: it clarified the commissions’ remit, updated the application form, shortened the list of documents, allowed three methods of submission, and discontinued the separate register of accredited facilities.
A facility may obtain the status of “accredited” or an accreditation category — second, first or highest — depending on the result of the expert assessment.
Need support in accrediting a medical facility?
The Dextra Law team will assess your facility’s readiness for accreditation, put the documents and the quality management system in order, and support the procedure from filing the application to obtaining the certificate. Contact us to discuss your facility’s situation and draw up a preparation plan.
