Basis: Law of Ukraine No. 86/95-VR "On Pesticides and Agrochemicals"; CMU Resolution No. 295 (04.03.1996, as amended through 1653-2025-p); CMU Resolution No. 966 (08.09.2023); Order No. 595 (20.11.2008, fees). Current as of the uploaded July 2026 texts.

1. Legal framework & classification

Ukraine has no dedicated legal category for plant biostimulants (no equivalent to EU Reg. 2019/1009). Both fertilisers and biostimulants are captured by the definition of "agrochemicals" in the Law: organic, mineral and bacterial fertilisers, chemical ameliorants, plant growth regulators and other substances used to improve soil fertility, yield and crop quality. Agrochemicals may not be imported, produced, sold, applied or advertised before State registration (Art. 4).

Classification is claim-driven, and this is the primary strategic risk:

- Nutrition / soil-improvement / plant-growth claims → agrochemical (fertiliser-type) registration.

- Microbial / biologically active products → still the agrochemical framework (with strain deposit requirements).

- Any plant-protection claim → risks being pulled into the pesticide pathway (heavier data set, longer timeline). Wording of the label and dossier claims should be controlled deliberately before entry.

Key fertiliser exemption: straight/commodity mineral fertilisers listed in the Annex to the Law (urea, ammonium nitrate, ammonium sulphate, superphosphate, potassium chloride/sulphate, NPK grades, sulphur, etc.) may be imported, traded and applied without State registration. Formulated/specialty products, blends with claims, and biostimulants fall outside this exemption and require registration.

2. Competent authority

Following recent restructuring (Resolution 1653-2025-p, Dec 2025), the registering authority is the Ministry of Economy (now consolidated as the Ministry of Economy, Environment and Agriculture — "Minekonomiky"), which conducts the eco-expert evaluation and maintains the State Register. The Ministry of Health provides the sanitary-epidemiological (toxicological-hygienic) expertise. Given the very recent authority merger and wartime administration, confirm the operative contact point and current fee table before filing.

3. Market-placement process (registration route)

1. Apply for inclusion in the State trials plan — accepted only until 25 March each year (nitrogen fertilisers: accepted year-round). This is a hard annual gate.

2. Inclusion into the plan within 30 calendar days of a complete dossier.

3. State trials (field + production), run in Ukraine:

- New active substance: two full vegetation periods.

- A.s. already registered for the same purpose/crop group: reducible to one vegetation period.

- Nitrogen fertilisers with an already-registered a.s.: trials may be replaced by review reports.

4. Toxicological-hygienic evaluation (MOH institutes), eco-toxicological evaluation, and residue method development.

5. Registration decision after payment of the expertise fee: statutory review ≤ 90 calendar days (nitrogen fertilisers with registered a.s.: ≤ 40 days).

6. Entry into the State Register; registration valid for up to 10 years.

4. Two registration types

- Experimental / temporary — issued for 1–2 years; allows import and sale; needs one season of bio-efficacy trials; tox studies on the a.i. deferred. Cannot be extended more than once, and scope of use cannot be expanded.

- Permanent — issued for up to 10 years; requires full tox evaluation of a.i. and product; no second season of bio-efficacy trials.

5. Document requirements

For trials-plan inclusion (by 25 March): product dossier/detailed info; SDS/MSDS; Certificate of Analysis (product and a.i.); a.i. identification method (CIPAC); manufacturer letter-authorisation; power of attorney.

For registration: application form in the approved format (Ukrainian, 2 copies); dossier on a.i. and formulation (Ukrainian or English, 2 copies); certificate of composition constancy; State-trials report (or review report for N-fertilisers); residue-determination methods; draft label per Art. 10; manufacturer authorisation; power of attorney. Bacterial products additionally require a strain deposit certificate and strain passport.

6. Language & format

Application and most documents in Ukrainian (the "or Russian" option was removed by Resolution 966/2023…). Dossier materials may be Ukrainian or English; foreign toxicological/eco-toxicological studies are accepted in English, and GLP data is accepted where quality is adequate. Submissions as hard copy (study reports may be on CD). Bio-efficacy trials and residue studies must be generated in Ukraine.

7. Timelines

The 90-day statutory review is only the final step. End-to-end timing is governed by the in-country trial seasons and the single annual (25 March) intake:

- Temporary/experimental: ~1–1.5 years.

- Permanent: ~2–2.5 years total (including the temporary phase).

The "6–12 months" figure sometimes quoted conflates the statutory review with the whole process and is not realistic for a new foreign biostimulant needing trials. Missing the 25 March intake loses a full year — plan the filing calendar backward from it.

8. Costs

There is no published flat fee. Fees are set by Order No. 595 (20.11.2008) for expertise, registration and re-registration, and vary by product type, new vs. re-registration, and extent of review; receipts go to a special State-budget fund. It’s recommended to bbtain the current fee table from the authority/local consultant before budgeting — the 2008 order has been amended and the fee point of contact shifted with the Dec 2025 restructuring.

9. Data protection & practical flags

- The Law grants 10-year data protection from the date of registration (dossier/safety documentation cannot be relied on by a third party without consent). In practice, reliance/data-sharing mechanisms are limited and generics often regenerate studies.

- No "me-too" registration and no second brand name on one registration.

- A registration can be transferred/sold (owner change is possible in Ukraine).

- Since 2014, the applicant must warrant no infringement of third-party Ukrainian patents — run a patent search (and consider a trademark filing) before starting.

You need help with your product registration in Ukraine? Get in touch.

We wish you a great day,

The sciBASICS Team.