Medical Licence for a Clinic of Reproductive Medicine
Embryology Laboratory • Cryobank • IVF • Donation • Surrogacy | Dextralaw
Assisted Reproductive Technology (ART) Clinic — The Most Complex Licensing Project in Medicine
Over the past five years, we have supported the opening and re-registration of licences for more than thirty reproductive medicine clinics in Ukraine. Every time we begin by explaining one thing to the founders: a reproductive technology clinic is not a single room with a chair, but a complex medical infrastructure where assisted reproductive technologies (ART) operate in parallel across several specialised zones.
This is a multi-zone facility where outpatient consultations, ultrasound diagnostics, an operating room for punctures, an embryology laboratory with incubators and micromanipulators, a cryobank with liquid nitrogen, a genetic laboratory and an andrology room all function simultaneously.
Each of these zones has its own requirements for premises, equipment, personnel and SOPs. In practice, the licensing package for an assisted reproductive technology clinic turns out to be 3–5 times larger than for a regular gynaecological clinic. And a mistake in the embryology laboratory is not just a regulatory breach — it means lost human embryos, civil lawsuits, criminal proceedings.
We have written in detail about the contractual framework for reproductive medicine clinics — surrogacy, donor programmes, cryopreservation — in our dedicated article. This material is about licensing.
“Licensing an ART clinic is not about filling out forms. We start with planning the premises and end with a contract with the NHSU for free IVF. Between these two points are dozens of documents, SOPs and approvals that we handle ourselves.”
— From the practice of Dextralaw lawyers
Legislative Framework
- Law of Ukraine “On Licensing of Economic Activities” — clause 15, part 1, article 7: medical practice is subject to licensing
- Resolution of the Cabinet of Ministers of Ukraine No. 285 of 02.03.2016 — Licensing Conditions (as amended by No. 1393, No. 536, No. 781 of 02.07.2025)
- Order of the Ministry of Health No. 787 of 09.09.2013 (as amended on 29.01.2025) — Procedure for the Application of ART: IVF, ICSI, donation, cryopreservation, surrogacy
- Family Code of Ukraine — art. 123 (determination of parents under ART), art. 139 (prohibition on challenging the maternity of a surrogate mother)
- Law of Ukraine “Fundamentals of Healthcare Legislation” — art. 48 (artificial insemination), art. 43 (informed consent)
- Law of Ukraine “On Personal Data Protection” — art. 7 (genetic and medical data)
- Resolution of the Cabinet of Ministers No. 1808 of 31.12.2025 — Procedure for implementing the Medical Guarantees Programme in 2026 (package “Treatment of Infertility by ART Methods”)
- Criminal Code of Ukraine — art. 138 (illegal medical activity), art. 140 (improper performance of duties), art. 145 (medical confidentiality)
Specialties in the Licence of a Reproductive Technology Clinic
The minimum set of specialties required for a fully functioning reproductive medicine clinic looks as follows:
| Specialty | What it permits | Personnel requirements |
|---|---|---|
| Obstetrics and Gynaecology | Consultations, examinations, ovarian stimulation, follicle puncture, embryo transfer, management of pregnancy after IVF. | Obstetrician-gynaecologist (reproductologist) with a specialist certificate and ART training. |
| Anaesthesiology | Anaesthesia for follicle puncture, sedation. Mandatory for invasive procedures. | Anaesthesiologist. Anaesthesia nurse. |
| Medical Genetics | Preimplantation genetic diagnosis (PGD/PGT), medical genetic counselling, embryo cryoscreening. | Medical geneticist with the relevant certificate. |
| Clinical Laboratory Diagnostics | Hormonal testing, spermogram, blood tests, infection screening. | Laboratory physician or laboratory diagnostics specialist. |
| Ultrasound Diagnostics | Follicometry, monitoring of stimulation, ultrasound of pelvic organs, early pregnancy. | Ultrasound physician or gynaecologist with the right to perform ultrasound. |
| Urology | Diagnosis and treatment of male infertility, TESA/MESA (testicular biopsy), consultations. | Urologist with a specialist certificate. |
| Endocrinology | Hormonal disorders, polycystic ovary syndrome, thyroid pathology in infertility. | Endocrinologist. |
| Healthcare Organisation and Management | Mandatory for the head of the institution. | Head of the clinic with the relevant certificate. |
| Nursing / Midwifery | Mid-level medical personnel: injections, blood sampling, assistance during procedures, documentation. | Junior specialists with medical education. |
An important change in 2025. CMU Resolution No. 781 introduced differentiation of licensing by specialty. Now a violation or temporary absence of a specialist in one specialty does not entail suspension of the licence for the entire activity — only for that specialty. For clinics with 6–10 specialties, this is fundamentally important: the risk of the whole clinic “collapsing” because one specialist resigned is now closed.
Embryology Laboratory
This is a unit that has no equivalent in any other field of medicine. It works with human embryos — biological material for which temperature, air quality, vibration, lighting and sterility are all critical.
Mandatory Equipment and Zones
| Equipment / zone | Purpose and requirements |
|---|---|
| CO₂ incubators (minimum 2) | Embryo culture. Double control of temperature and gas composition. Alarm system. |
| Laminar flow hood (Class II) | Manipulation of oocytes and embryos under sterile conditions. HEPA air filtration. |
| Micromanipulation station (ICSI) | Intracytoplasmic sperm injection. Inverted microscope + micromanipulators. |
| Cryostorage (cryobank) | Storage of embryos, oocytes, sperm in liquid nitrogen (-196°C). Nitrogen-level sensors. 24/7 alert system. |
| Embryoscope (time-lapse) | Continuous monitoring of embryo development without removal from the incubator. Improves the quality of selection. |
| Spermogram centrifuge | Sperm preparation: gradient centrifugation, swim-up. |
| Air quality control system | VOC filters, HEPA, particle control. Embryos are sensitive to volatile organic compounds. |
| Backup power supply | UPS + generator. A power outage = death of embryos in the incubators. |
Requirements for the Laboratory Premises
- Separate room with controlled microclimate: temperature 25±1°C, humidity 40–60%
- VOC air filtration system (volatile organic compounds are toxic to embryos)
- Anti-vibration tables for micromanipulators
- No direct sunlight (UV harms embryos)
- Restricted access: only certified embryologists
- Daily log of environmental parameters: temperature, CO₂, air quality
“An embryology laboratory is a high-tech operation working with families’ destinies. One labelling error and the embryo goes to the wrong couple. One incubator failure without backup power and dozens of embryos die over the weekend. The lawyer’s job is to build a documentary system in which these risks are reduced to a controlled minimum.”
— From Dextralaw’s experience supporting ART clinics
Cryobank: The Legal Side of Frozen Material
Cryopreservation of embryos, oocytes and sperm is regulated by Section VII of the Order of the Ministry of Health No. 787. Technically it is a storage zone. Legally it is the unit we receive more claims about than any other:
- The legal status of an embryo. Current Ukrainian legislation does not define an embryo as a subject or an object of law. This creates uncertainty in cases of divorce, the death of one of the spouses, and disputes over the fate of frozen embryos. In our practice, every second conflict around a cryobank is about exactly this.
- The cryopreservation contract. Must necessarily define storage periods, cost, actions in case of non-payment, the fate of the material in case of divorce or death, and the disposal procedure.
- Donor material. Donor anonymity, quarantine periods (6 months for sperm), genetic screening — all regulated by Section V of Order No. 787.
- Technical requirements. Liquid nitrogen tanks, 24/7 level sensors, automatic alerts when levels fall, a duplicate tank, a logbook recording every storage unit.
⚖ Section VII of MoH Order No. 787: Cryopreservation of reproductive cells and embryos — procedure, terms, accounting.
Contract with the NHSU: Free IVF Under the Medical Guarantees Programme
Since 2024, infertility treatment by ART methods has been included in the Medical Guarantees Programme (MGP). A clinic with a medical practice licence can enter into a contract with the National Health Service of Ukraine (NHSU) and provide patients with up to 2 free IVF cycles per year.
Requirements for Entering Into a Contract with the NHSU
- A valid licence with the relevant specialties
- Compliance with quality indicator metrics
- A multidisciplinary council (MDC) for patient selection
- An embryology laboratory equipped for IVF/ICSI
- The ability to cryopreserve embryos
- Electronic document workflow through the eHealth system
We help clinics not only obtain the licence but also prepare to enter into a contract with the NHSU — we check compliance, prepare the proposal and support the signing process.
8 Stages of Licensing with Dextralaw
| № | Stage | What Dextralaw does |
|---|---|---|
| 1 | Clinic concept: defining the list of services (IVF, ICSI, donation, surrogacy, cryopreservation, PGT). | Consultation on which specialties are needed in the licence, which premises, equipment and personnel are required. |
| 2 | Premises audit: compliance of the embryology laboratory, operating room and cryobank with licensing requirements. | On-site audit. Checklist with 80+ items. Roadmap for eliminating non-conformities. |
| 3 | Personnel audit: verification of each specialist’s qualifications, validity of certificates and attestations. | Verification of diplomas, certificates, length of service. Recommendations for staffing. |
| 4 | Preparation of the licensing package: application, Appendix 2 (material-technical base + personnel), Appendix 3. | 100% of documentation prepared “turnkey”. Verification of every line of the Statement. |
| 5 | Development of internal documents: SOPs for the embryology lab, cryobank, donor programmes, surrogacy. | Full package: 15+ SOPs, informed consents, contracts, NDAs, personal data policy. |
| 6 | Filing with the MoH and follow-up: “Single Window”, deadline control, responding to enquiries. | Communication with the MoH on your behalf. In case of refusal — appeal. |
| 7 | NHSU contract (MGP): preparation for entering into a contract for free IVF under the Medical Guarantees Programme. | Verification of compliance with indicator metrics. Preparation of the proposal. |
| 8 | Post-licensing support: changes to the licence, preparation for inspections, expansion of specialties. | Legal subscription. Update of documents when legislation changes. |
Internal Documents: From Lab SOPs to the Surrogacy Contract
A licence gives you the right to operate. But an ART clinic requires an unprecedented volume of internal documentation:
- Embryology lab SOPs: biomaterial identification (double verification), culture, vitrification, thawing, ICSI
- Cryobank SOPs: accounting, labelling, nitrogen refilling, emergency protocol, transfer/disposal
- Donor programme SOPs: selection, examination, quarantine, anonymity, donor informed consent
- Surrogacy SOPs: document list, medical protocol, handover of the child, registration with the civil registry office (RATSAHS)
- Informed consents: separate for each programme (IVF, ICSI, oocyte donation, sperm donation, PGT, cryopreservation)
- Contracts with patients and third parties: ART agreement, surrogacy contract, cryopreservation contract, donation contract
- Personal data protection policy: genetic information, donor data, embryo photos
- NDAs with personnel: embryologists, lab technicians and administrators have access to the most sensitive data
More on the contractual framework — in our article on contracts in reproductive medicine.
Cases From Our Practice
Case 1. Embryo Mix-up Due to the Absence of an Identification SOP
⚠ The situation. An embryologist mixed up the labelling of the test tubes. Couple A’s embryo was transferred to Couple B. The error was discovered only after the newborn’s DNA test. The child was not genetically related to the woman who carried him. This is the most severe type of situation an ART clinic can ever face.
⚖ Legal basis. Breach of licensing conditions (absence of an SOP on double verification). Article 140 of the Criminal Code of Ukraine — improper performance of duties by a medical professional. Civil claim under arts. 1166–1167 of the Civil Code of Ukraine. Legal context — the case of Paradiso and Campanelli v. Italy at the ECtHR, where a similar collision was considered at Grand Chamber level.
❌ Outcome. Criminal proceedings. Lawsuits from both couples for a total of more than UAH 2,000,000. Licence revoked.
Takeaway from the case. The double-verification SOP is when the embryologist and a nurse independently check the patient’s name on the tube at every stage: when oocytes are retrieved, at fertilisation, during culture, at transfer. It sounds like unnecessary bureaucracy. In practice — it is the only barrier between the clinic working normally and losing everything.
Case 2. IVF Without the Specialty “Medical Genetics” in the Licence
⚠ The situation. The clinic offered patients preimplantation genetic testing (PGT) of embryos, but the specialty “medical genetics” was not included in the licence. The genetic analysis was carried out by a “biologist without medical education”. An embryo with a chromosomal abnormality was transferred to the patient — the pregnancy ended in loss.
⚖ Legal basis. Provision of services in a specialty not included in the licence — a breach of the Licensing Conditions. Article 138 of the Criminal Code of Ukraine — illegal medical activity.
❌ Outcome. Licence suspension. Patient’s lawsuit: full refund of the programme cost (EUR 48,000) + moral damages of UAH 500,000. Criminal proceedings. Including “medical genetics” in the licence from day one is the only legal way to provide PGT.
Case 3. Cryobank Accident: Loss of Embryos
⚠ The situation. The liquid nitrogen level sensor in the clinic’s cryobank failed. Over the weekend the level dropped to a critical point. There was no alert system — staff only found out on Monday. 47 cryopreserved embryos belonging to 12 couples were destroyed.
I’ll add separately: for some of these couples, these were the only embryos they had managed to obtain after years of attempts.
⚖ Legal basis. Absence of an SOP for cryobank monitoring and a 24/7 alert system — a breach of licensing conditions. Article 906 of the Civil Code of Ukraine — the contractor’s liability under a services contract.
❌ Outcome. 12 lawsuits for a total of more than UAH 3,500,000. MoH inspection, formal notice, threat of revocation. A 24/7 monitoring system with SMS/email alerts plus a duplicate tank — this is the standard that saves clinics.
Case 4. Foreign Couple: Refusal to Register the Child
⚠ The situation. The clinic ran a surrogacy programme for a couple from Germany. The child was born, but the German Embassy refused to recognise the parentage: surrogacy is prohibited in Germany. The clinic had not arranged legal support for registration in the case of foreigners. ⚖ Legal basis — collision between art. 123 of the Family Code of Ukraine and German law (BGB §1591: the mother is the woman who gave birth). A court determination of parentage in Ukraine was required under the Civil Procedure Code of Ukraine (separate proceedings).
❌ Outcome. The child remained in Ukraine for 5 months. Parents’ additional expenses: EUR 15,000 (lawyer + accommodation). The clinic lost its reputation with foreign agencies.
Case 5. Leak of Oocyte Donor Information
⚠ The situation. A clinic administrator accidentally emailed a file with the donor database (full names, photos, contacts, medical data) to the wrong addressee. The information ended up online. 8 donors filed complaints.
⚖ Legal basis. Breach of art. 7 of the Law of Ukraine “On Personal Data Protection” (processing of health data), art. 40 of the Law “Fundamentals” (medical confidentiality), art. 145 of the Criminal Code of Ukraine (criminal liability for disclosure). Breach of donor anonymity — Section V of Order No. 787.
❌ Outcome. Fines imposed on the responsible person. Criminal proceedings. 8 lawsuits for moral damages (totalling approximately UAH 400,000). The clinic lost 60% of its donor base.
What we do in such cases. A proper personal data SOP, NDAs with everyone who has access to the database, technical encryption of files containing donor data and an access logbook — this is the minimum package we implement for clients at the licensing preparation stage. Cheaper than paying out claims later.
“In an ART clinic we work with three of the most sensitive categories at once: human embryos, genetic information and family destinies. No other branch of medicine carries this level of responsibility.”
— From Dextralaw’s medical practice experience
Dextralaw: Turnkey Licensing of an Assisted Reproductive Technology ClinicQuestions and Answers
Dextralaw law firm offers a full cycle of services for reproductive medicine clinics and assisted reproductive technology centres:
- Concept audit: determining the optimal list of specialties, zones and equipment
- Turnkey licensing package: 100% of documentation — from the application to internal SOPs
- Setup support: checklists for the laboratory, cryobank, operating room
- Development of 15+ SOPs: embryology, cryobank, donation, surrogacy, personal data
- Contractual framework: contracts with patients, donors, surrogate mothers, agencies
- NHSU contract: preparation and support for entry into the free IVF programme
- Legal support for foreign programmes: registration, civil registry office, embassies, courts
- Post-licensing subscription: MoH inspections, licence amendments, document updates
Questions and Answers
It differs fundamentally in the scope of requirements. A gynaecological clinic needs 2–3 specialties and a standard room. A reproductive technology clinic needs 6–10 specialties, an embryology laboratory with controlled microclimate, a cryobank with liquid nitrogen, an operating room for punctures, an andrology room. The licensing package is 3–5 times larger.
No. The cryobank is a structural unit of the clinic and is included in the general medical practice licence. However, it must be listed in the Statement (Appendix 2) as a separate premises with an equipment list. A separate licence is required for the operation of cord blood banks and other tissue banks — that is a different type of activity.
The state fee is one subsistence minimum (UAH 3,028 in 2025). The MoH makes a decision within 10 working days. But the actual preparation period is from 2 to 6 months, depending on the condition of the premises and the readiness of the equipment. Most of the time goes into setting up the laboratory, equipping the cryobank, and recruiting personnel.
Yes, the licence does not differentiate patients by citizenship. However, working with foreigners requires additional legal support: a check of the parents’ country legislation (especially for surrogacy), document legalisation (apostille), court determination of parentage, support during registration with the civil registry office and the embassy.
The clinic must hold a valid licence, meet the indicator metrics, have an embryology laboratory and the ability to cryopreserve. A proposal must be submitted in response to the NHSU’s announcement. We prepare the full package for entering into the contract and support the process through to signing.
The main change is the differentiation of licensing by specialty. Previously, a breach in any specialty could lead to suspension of the entire licence. Now the MoH can suspend the licence only for a specific specialty, leaving the right to operate in the others. For ART clinics with 6–10 specialties this is a significant reduction in risk.
